Trulicity

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT  
 
Trulicity 0.75 mg solution for injection in pre-filled pen 
Trulicity 1.5 mg solution for injection in pre-filled pen 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Trulicity 0.75 mg solution for injection 
Each pre-filled pen contains 0.75 mg of dulaglutide* in 0.5 ml solution. 
 
Trulicity 1.5 mg solution for injection  
Each pre-filled pen contains 1.5 mg of dulaglutide* in 0.5 ml solution. 
 
*Produced in CHO cells by recombinant DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection.  
Clear, colourless solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Type 2 Diabetes Mellitus 
 
Trulicity is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus 
as an adjunct to diet and exercise 

• as monotherapy when metformin is considered inappropriate due to intolerance or 
contraindications 

• in addition to other medicinal products for the treatment of diabetes.  
For study results with respect to combinations, effects on glycaemic control and cardiovascular events, 
and the populations studied, see sections 4.4, 4.5 and 5.1. 
 
4.2  Posology and method of administration 
 
Posology 
 
Monotherapy  
The recommended dose is 0.75 mg once weekly. 
 
Add-on therapy 
The recommended dose is 1.5 mg once weekly. 
For potentially vulnerable populations 0.75 mg once weekly can be considered as a starting dose.  
 
When Trulicity is added to existing metformin and/or pioglitazone therapy, the current dose of 
metformin and/or pioglitazone can be continued. When Trulicity is added to existing metformin and/or 
sodium-glucose co-transporter 2 inhibitor (SGLT2i) therapy, the current dose of metformin and/or 
SGLT2i can be continued. When it is added to existing therapy of a sulphonylurea or insulin, a 
reduction in the dose of sulphonylurea or insulin may be considered to reduce the risk of 
hypoglycaemia (see sections 4.4 and 4.8). 
 



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The use of Trulicity does not require blood glucose self-monitoring. Blood glucose self-monitoring is 
necessary to adjust the dose of sulphonylurea or insulin, particularly when Trulicity therapy is started 
and insulin is reduced. A stepwise approach to insulin dose reduction is recommended. 
 
Elderly 
No dose adjustment is required based on age (see section 5.2).  
 
Renal impairment 
No dosage adjustment is required in patients with mild, moderate or severe renal impairment (eGFR 
<90 to ≥15 mL/min/1.73m2). 
 
There is very limited experience in patients with end stage renal disease (<15 ml/min/1.73m2), 
therefore Trulicity cannot be recommended in this population (see sections 5.1 and 5.2). 
 
Hepatic impairment 
No dosage adjustment is required in patients with hepatic impairment. 
 
Paediatric population 
The safety and efficacy of dulaglutide in children aged less than 18 years have not yet been 
established. No data are available. 
 
Method of administration 
 
Trulicity is to be injected subcutaneously in the abdomen, thigh or upper arm. It should not be 
administered intravenously or intramuscularly. 
 
The dose can be administered at any time of day, with or without meals.  
 
If a dose is missed, it should be administered as soon as possible if there are at least 3 days (72 hours) 
until the next scheduled dose. If less than 3 days (72 hours) remain before the next scheduled dose, the 
missed dose should be skipped and the next dose should be administered on the regularly scheduled 
day. In each case, patients can then resume their regular once weekly dosing schedule. 
 
The day of weekly administration can be changed if necessary, as long as the last dose was 
administered 3 or more days (72 hours) before. 
 
4.3 Contraindications  
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use  
 
Dulaglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic 
ketoacidosis. Dulaglutide is not a substitute for insulin. Diabetic ketoacidosis has been reported in 
insulin-dependent patients after rapid discontinuation or dose reduction of insulin (see section 4.2). 
 
Dehydration 
Dehydration, sometimes leading to acute renal failure or worsening renal impairment, has been 
reported in patients treated with dulaglutide, especially at the initiation of treatment. Many of the 
reported adverse renal events occurred in patients who had experienced nausea, vomiting, diarrhoea, 
or dehydration. Patients treated with dulaglutide should be advised of the potential risk of dehydration, 
particularly in relation to gastrointestinal side-effects and take precautions to avoid fluid depletion. 
 
Dulaglutide has not been studied in patients with severe gastrointestinal disease, including severe 
gastroparesis, and is therefore not recommended in these patients. 
 



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Acute pancreatitis 
Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis. In 
clinical trials, acute pancreatitis has been reported in association with dulaglutide (see section 4.8). 
 
Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is 
suspected, dulaglutide should be discontinued. If pancreatitis is confirmed, dulaglutide should not be 
restarted. In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic 
enzymes alone are not predictive of acute pancreatitis (see section 4.8). 
 
Hypoglycaemia 
Patients receiving dulaglutide in combination with sulphonylurea or insulin may have an increased 
risk of hypoglycaemia. The risk of hypoglycaemia may be lowered by a reduction in the dose of 
sulphonylurea or insulin (see sections 4.2 and 4.8). 
 
Sodium content 
This medicinal product contains less than 1 mmol sodium (23 mg) per 1.5 mg dose, i.e. essentially 
‘sodium- free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Dulaglutide delays gastric emptying and has the potential to impact the rate of absorption of 
concomitantly administered oral medicinal products. In the clinical pharmacology studies described 
below, dulaglutide did not affect the absorption of the orally administered medications tested to any 
clinically relevant degree. However, for patients receiving oral medicinal products requiring rapid 
gastrointestinal absorption or prolonged release formulations the potential for altered drug exposure 
should be considered.   
 
Sitagliptin 
Sitagliptin exposure was unaffected when coadministered with a single dose of dulaglutide. Following 
coadministration with 2 consecutive doses of dulaglutide, sitagliptin AUC(0-τ) and Cmax decreased by 
approximately 7.4 % and 23.1 %, respectively. Sitagliptin tmax increased approximately 0.5 hours 
following coadministration with dulaglutide compared to sitagliptin alone. 
 
Sitagliptin can produce up to 80 % inhibition of DPP-4 over a 24-hour period. Dulaglutide 
coadministration with sitagliptin increased dulaglutide exposure and Cmax by approximately 38 % and 
27 %, respectively, and median tmax increased approximately 24 hours. Therefore, dulaglutide does 
have a high degree of protection against DPP-4 inactivation (see section 5.1, Mechanism of action). 
The increased exposure may enhance the effects of dulaglutide on blood glucose levels. 
 
Paracetamol 
Following a first dose of 1 and 3 mg dulaglutide, paracetamol Cmax was reduced by 36 % and 50 %, 
respectively, and the median tmax occurred later (3 and 4 hours, respectively). After coadministration 
with up to 3 mg of dulaglutide at steady state, there were no statistically significant differences on 
AUC(0-12), Cmax or tmax of paracetamol. No dose adjustment of paracetamol is necessary when 
administered with dulaglutide. 
 
Atorvastatin 
Coadministration of dulaglutide with atorvastatin decreased Cmax and AUC(0-∞) up to 70 % and 21 %, 
respectively, for atorvastatin and its major metabolite o-hydroxyatorvastatin. The mean t1/2 of 
atorvastatin and o-hydroxyatorvastatin were increased by 17 % and 41 %, respectively, following 
dulaglutide administration. These observations are not clinically relevant. No dose adjustment of 
atorvastatin is necessary when administered with dulaglutide. 
 
Digoxin  
After coadministration of steady state digoxin with 2 consecutive doses of dulaglutide, overall 
exposure (AUCτ) and tmax of digoxin were unchanged; and Cmax decreased by up to 22 %. This change 



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is not expected to have clinical consequences. No dose adjustment is required for digoxin when 
administered with dulaglutide. 
 
Anti-hypertensives 
Coadministration of multiple dulaglutide doses with steady state lisinopril caused no clinically 
relevant changes in the AUC or Cmax of lisinopril. Statistically significant delays in lisinopril tmax of 
approximately 1 hour were observed on Days 3 and 24 of the study. When a single dose of dulaglutide 
and metoprolol were coadministered, the AUC and Cmax of metoprolol increased by19 % and 32 %, 
respectively. While metoprolol tmax was delayed by 1 hour, this change was not statistically significant. 
These changes were not clinically relevant; therefore no dose adjustment of lisinopril or metoprolol is 
necessary when administered with dulaglutide. 
 
Warfarin  
Following dulaglutide coadministration, S- and R-warfarin exposure and R-warfarin Cmax were 
unaffected, and S-warfarin Cmax decreased by 22 %. AUCINR increased by 2 %, which is unlikely to be 
clinically significant, and there was no effect on maximum international normalised ratio response 
(INRmax). The time of international normalised ratio response (tINRmax) was delayed by 6 hours, 
consistent with delays in tmax of approximately 4 and 6 hours for S- and R-warfarin, respectively. 
These changes are not clinically relevant. No dose adjustment for warfarin is necessary when given 
together with dulaglutide. 
 
Oral contraceptives 
Coadministration of dulaglutide with an oral contraceptive (norgestimate 0.18 mg/ethinyl estradiol 
0.025 mg) did not affect the overall exposure to norelgestromin and ethinyl estradiol. Statistically 
significant reductions in Cmax of 26 % and 13 % and delays in tmax of 2 and 0.30 hours were observed 
for norelgestromin and ethinyl estradiol, respectively. These observations are not clinically relevant. 
No dose adjustment for oral contraceptives is required when given together with dulaglutide. 
 
Metformin 
Following coadministration of multiple dose dulaglutide with steady state metformin (immediate 
release formula [IR]), metformin AUCτ increased up to 15 % and Cmax decreased up to 12 %, 
respectively, with no changes in tmax. These changes are consistent with the gastric emptying delay of 
dulaglutide and within the pharmacokinetic variability of metformin and thus are not clinically 
relevant. No dose adjustment for metformin IR is recommended when given with dulaglutide. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no or limited amount of data from the use of dulaglutide in pregnant women. Studies in 
animals have shown reproductive toxicity (see section 5.3). Therefore, the use of dulaglutide is not 
recommended during pregnancy. 
 
Breast-feeding 
It is unknown whether dulaglutide is excreted in human milk. A risk to newborns/infants cannot be 
excluded. Dulaglutide should not be used during breast-feeding. 
 
Fertility 
The effect of dulaglutide on fertility in humans is unknown. In the rat, there was no direct effect on 
mating or fertility following treatment with dulaglutide (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Trulicity has no or negligible influence on the ability to drive or use machines. When it is used in 
combination with a sulphonylurea or insulin, patients should be advised to take precautions to avoid 
hypoglycaemia while driving and using machines (see section 4.4). 
 



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4.8 Undesirable effects  
 
Summary of safety profile 
In the completed phase II and phase III initial registration studies, 4,006 patients were exposed to 
dulaglutide alone or in combination with other glucose lowering medicinal products. The most 
frequently reported adverse reactions in clinical trials were gastrointestinal, including nausea, 
vomiting and diarrhoea. In general these reactions were mild or moderate in severity and transient in 
nature. Results from the long-term cardiovascular outcome study with 4949 patients randomised to 
dulaglutide and followed for a median of 5.4 years were consistent with these findings. 
 
Tabulated list of adverse reactions 
The following adverse reactions have been identified based on evaluation of the full duration of the 
phase II and phase III clinical studies, the long-term cardiovascular outcome study and post-marketing 
reports. The adverse reactions are listed in Table 1 as MedDRA preferred term by system organ class 
and in order of decreasing incidence (very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: 
≥ 1/1,000 to < 1/100; rare: ≥ 1/10,000 to < 1/1,000; very rare: < 1/10,000 and not known: cannot be 
estimated from available data). Within each incidence grouping, adverse reactions are presented in 
order of decreasing frequency. Frequencies for events have been calculated based on their incidence in 
the phase II and phase III registration studies. 
 
Table 1: The frequency of adverse reactions of dulaglutide 
 

System Organ 
Class 

 

Very common Common 
 

Uncommon 
 

Rare Not 
known 

Immune system 
disorders  

  Hypersensitivity 
 

Anaphylactic 
reaction# 

 

Metabolism 
and nutrition 
disorders 

Hypoglycaemia* 
(when used in 
combination 
with insulin, 
glimepiride, 
metformin† or 
metformin plus 
glimepiride) 

Hypoglycaemia* 
(when used as 
monotherapy or 
in combination 
with metformin 
plus 
pioglitazone) 

Dehydration   

Gastrointestinal 
disorders 

Nausea, 
diarrhoea, 
vomiting†, 
abdominal pain† 

Decreased 
appetite, 
dyspepsia, 
constipation, 
flatulence, 
abdominal 
distention, 
gastroesophageal 
reflux disease, 
eructation 

 Acute 
pancreatitis 

Non-
mechanical 
intestinal 
obstruction 

Hepatobiliary 
disorders 

  Cholelithiasis, 
cholecystitis 

  

Skin and 
subcutaneous 
tissue disorders 

   Angioedema#  

General 
disorders and 
administration 
site conditions 

 Fatigue Injection site 
reactions 

  

Investigations  Sinus 
tachycardia, first 
degree 

   



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# From post-marketing reports.  
* Documented, symptomatic hypoglycaemia with blood glucose ≤ 3.9 mmol/L 
† Dulaglutide 1.5 mg dose only. For dulaglutide 0.75 mg, adverse reaction met frequency for next 

lower incidence grouping. 
 
Description of selected adverse reactions 
 
Hypoglycaemia 
When dulaglutide 0.75 mg and 1.5 mg were used as monotherapy or in combination with metformin 
alone or metformin and pioglitazone, the incidences of documented symptomatic hypoglycaemia were 
5.9% to 10.9% and the rates were 0.14 to 0.62 events/patient/year, and no episodes of severe 
hypoglycaemia were reported. 
 
The incidences of documented symptomatic hypoglycaemia when dulaglutide 0.75 mg and 1.5 mg, 
respectively, were used in combination with a sulphonylurea and metformin were 39.0% and 40.3% 
and the rates were 1.67 and 1.67 events/patient/year. The severe hypoglycaemia event incidences were 
0% and 0.7%, and rates were 0.00 and 0.01 events/patient/year for each dose, respectively. The 
incidence of documented symptomatic hypoglycaemia when dulaglutide 1.5 mg was used with 
sulphonylurea alone was 11.3% and the rate was 0.90 events/patient/year, and there were no episodes 
of severe hypoglycaemia. 
 
The incidence of documented symptomatic hypoglycaemia when dulaglutide 1.5 mg was used in 
combination with insulin glargine was 35.3% and the rate was 3.38 events/patient/year. The severe 
hypoglycaemia event incidence was 0.7% and the rate was 0.01 events/patient/year. 
 
The incidences when dulaglutide 0.75 mg and 1.5 mg, respectively, were used in combination with 
prandial insulin were 85.3% and 80.0% and rates were 35.66 and 31.06 events/patient/year. The severe 
hypoglycaemia event incidences were 2.4% and 3.4%, and rates were 0.05 and 
0.06 events/patient/year. 
 
Gastrointestinal adverse reactions 
Cumulative reporting of gastrointestinal events up to 104 weeks with dulaglutide 0.75mg and 1.5 mg, 
respectively, included nausea (12.9% and 21.2 %), diarrhoea (10.7% and 13.7 %) and vomiting (6.9% 
and 11.5 %). These were typically mild or moderate in severity and were reported to peak during the 
first 2 weeks of treatment and rapidly declined over the next 4 weeks, after which the rate remained 
relatively constant. 
 
In clinical pharmacology studies conducted in patients with type 2 diabetes mellitus up to 6 weeks, the 
majority of gastrointestinal events were reported during the first 2-3 days after the initial dose and 
declined with subsequent doses. 
 
Acute pancreatitis  
The incidence of acute pancreatitis in Phase II and III clinical studies was 0.07% for dulaglutide 
compared to 0.14% for placebo and 0.19% for comparators with or without additional background 
antidiabetic therapy. 
 
Pancreatic enzymes 
Dulaglutide is associated with mean increases from baseline in pancreatic enzymes (lipase and/or 
pancreatic amylase) of 11 % to 21 % (see section 4.4). In the absence of other signs and symptoms of 
acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis. 
 
Heart rate increase  
Small mean increases in heart rate of 2 to 4 beats per minute (bpm) and a 1.3% and 1.4 % incidence of 
sinus tachycardia, with a concomitant increase from baseline ≥ 15 bpm, were observed with 
dulaglutide 0.75mg and 1.5 mg, respectively. 

atrioventricular 
block (AVB) 



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First degree AV block/PR interval prolongation  
Small mean increases from baseline in PR interval of 2 to 3 msec and a 1.5% and 2.4 % incidence of 
first-degree AV block were observed with dulaglutide 0.75 mg and 1.5 mg, respectively. 
 
Immunogenicity  
In clinical studies, treatment with dulaglutide was associated with a 1.6 % incidence of treatment 
emergent dulaglutide anti-drug antibodies, indicating that the structural modifications in the GLP-1 
and modified IgG4 parts of the dulaglutide molecule, together with high homology with native GLP-1 
and native IgG4, minimise the risk of immune response against dulaglutide. Patients with dulaglutide 
anti-drug antibodies generally had low titres, and although the number of patients developing 
dulaglutide anti-drug antibodies was low, examination of the phase III data revealed no clear impact of 
dulaglutide anti-drug antibodies on changes in HbA1c. None of the patients with systemic 
hypersensitivity developed dulaglutide anti-drug antibodies. 
 
Hypersensitivity  
In the phase II and phase III clinical studies, systemic hypersensitivity events (e.g., urticaria, edema) 
were reported in 0.5 % of patients receiving dulaglutide.  Cases of anaphylactic reaction have been 
rarely reported with marketed use of dulaglutide.  
 
Injection site reactions  
Injection site adverse events were reported in 1.9 % of patients receiving dulaglutide. Potentially 
immune-mediated injection site adverse events (e.g., rash, erythema) were reported in 0.7 % of 
patients and were usually mild. 
 
Discontinuation due to an adverse event 
In studies of 26 weeks duration, the incidence of discontinuation due to adverse events was 2.6% 
(0.75 mg) and 6.1% (1.5 mg) for dulaglutide versus 3.7 % for placebo. Through the full study duration 
(up to 104 weeks), the incidence of discontinuation due to adverse events was 5.1% (0.75 mg) and 
8.4 % (1.5 mg) for dulaglutide. The most frequent adverse reactions leading to discontinuation for 
0.75 mg and 1.5 mg dulaglutide, respectively, were nausea (1.0%, 1.9 %), diarrhoea (0.5%, 0.6 %), 
and vomiting (0.4%, 0.6 %), and were generally reported within the first 4-6 weeks. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Effects of overdose with dulaglutide in clinical studies have included gastrointestinal disorders and 
hypoglycaemia. In the event of overdose, appropriate supportive treatment should be initiated 
according to the patient’s clinical signs and symptoms. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties  
 
Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins, 
ATC code: A10BJ05 
 
Mechanism of action 
Dulaglutide is a long-acting glucagon-like peptide 1 (GLP-1) receptor agonist. The molecule consists 
of 2 identical disulfide-linked chains, each containing a modified human GLP-1 analogue sequence 
covalently linked to a modified human immunoglobulin G4 (IgG4) heavy chain fragment (Fc) by a 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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small peptide linker. The GLP-1 analog portion of dulaglutide is approximately 90 % homologous to 
native human GLP-1 (7-37). Native GLP-1 has a half-life of 1.5-2 minutes due to degradation by 
DPP-4 and renal clearance. In contrast to native GLP-1, dulaglutide is resistant to degradation by 
DPP-4, and has a large size that slows absorption and reduces renal clearance. These engineering 
features result in a soluble formulation and a prolonged half-life of 4.7 days, which makes it suitable 
for once-weekly subcutaneous administration. In addition, the dulaglutide molecule was engineered to 
prevent the Fcγ receptor-dependent immune response and to reduce its immunogenic potential. 
 
Dulaglutide exhibits several antihyperglycaemic actions of GLP-1. In the presence of elevated glucose 
concentrations, dulaglutide increases intracellular cyclic AMP (cAMP) in pancreatic beta cells leading 
to insulin release. Dulaglutide suppresses glucagon secretion which is known to be inappropriately 
elevated in patients with type 2 diabetes. Lower glucagon concentrations lead to decreased hepatic 
glucose output. Dulaglutide also slows gastric emptying. 
 
Pharmacodynamic effects 
Dulaglutide improves glycaemic control through the sustained effects of lowering fasting, pre-meal 
and postprandial glucose concentrations in patients with type 2 diabetes starting after the first 
dulaglutide administration and is sustained throughout the once weekly dosing interval. 
 
A pharmacodynamic study with dulaglutide demonstrated, in patients with type 2 diabetes, a 
restoration of first phase insulin secretion to a level that exceeded levels observed in healthy subjects 
on placebo, and improved second phase insulin secretion in response to an intravenous bolus of 
glucose. In the same study, a single 1.5 mg dose of dulaglutide appeared to increase maximal insulin 
secretion from the β-cells, and to enhance β-cell function in subjects with type 2 diabetes mellitus as 
compared with placebo. 
 
Consistent with the pharmacokinetic profile, dulaglutide has a pharmacodynamic profile suitable for 
once weekly administration (see section 5.2). 
 
Clinical efficacy and safety 
 
Glycaemic control 
The safety and efficacy of dulaglutide were evaluated in nine randomised, controlled, phase III trials 
involving 6,193 patients with type 2 diabetes. Of these, 1,206 were ≥ 65 years of which 119 were 
≥ 75 years. These studies included 3,808 dulaglutide treated patients, of whom 2,250 were treated with 
Trulicity 1.5 mg weekly and 1,558 were treated with Trulicity 0.75 mg weekly. In all studies, 
dulaglutide produced clinically significant improvements in glycaemic control as measured by 
glycosylated haemoglobin A1c (HbA1c).  
 
Monotherapy 
Dulaglutide was studied in a 52 week active controlled monotherapy study in comparison to 
metformin. Trulicity 1.5 mg and 0.75 mg were superior to metformin (1500-2000 mg/day) in the 
reduction in HbA1c and a significantly greater proportion of patients reached an HbA1c target of 
< 7.0 % and ≤ 6.5 % with Trulicity 1.5 mg and Trulicity 0.75 mg compared to metformin at 26 weeks.  
 



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Table 2: Results of a 52 week active controlled monotherapy study with two doses of dulaglutide in 
comparison to metformin 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in  
body 

weight 
 (%) (%) <7.0% (%) ≤6.5% (%) (mmol/L) (kg) 

26 weeks 
Dulaglutide 1.5 mg 
once weekly (n=269) 7.63 -0.78

†† 61.5# 46.0## -1.61 -2.29 

Dulaglutide 0.75 mg 
once weekly (n=270) 7.58 -0.71

†† 62.6# 40.0# -1.46 -1.36# 

Metformin 
1500-2000 mg/day 
(n=268) 

7.60 -0.56 53.6 29.8 -1.34 -2.22 

52 weeks 
Dulaglutide 1.5 mg 
once weekly (n=269) 7.63 -0.70

†† 60.0# 42.3## -1.56# -1.93 

Dulaglutide 0.75 mg 
once weekly (n=270) 7.58 -0.55

† 53.2 34.7 -1.00 -1.09# 

Metformin 
1500-2000 mg/day 
(n=268) 

7.60 -0.51 48.3 28.3 -1.15 -2.20 

† multiplicity adjusted 1-sided p-value < 0.025, for noninferiority; †† multiplicity adjusted 1-sided 
p-value < 0.025, for superiority of dulaglutide to metformin, assessed  for HbA1c only 

# p < 0.05, ## p < 0.001 dulaglutide treatment group compared to metformin  
 
The rate of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and 
metformin were 0.62, 0.15, and 0.09 episodes/patient/year, respectively. No cases of severe 
hypoglycaemia were observed. 
 
Combination therapy with metformin  
The safety and efficacy of dulaglutide was investigated in a placebo and active controlled (sitagliptin 
100 mg daily) study of 104 weeks duration, all in combination with metformin. Treatment with 
Trulicity 1.5 mg and 0.75 mg resulted in a superior reduction in HbA1c compared to sitagliptin at 
52 weeks, accompanied by a significantly greater proportion of patients achieving HbA1c targets of 
< 7.0 % and ≤ 6.5 %. These effects were sustained to the end of the study (104 weeks).  
 



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Table 3: Results of a 104 week placebo and active controlled study with two doses of dulaglutide in 
comparison to sitagliptin 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in 
body 

weight 
 (%) (%) <7.0 %(%) ≤6.5 %(%) (mmol/L) (kg) 

26 weeks 
Dulaglutide 1.5 mg 
once weekly (n=304) 8.12 -1.22

‡‡,## 60.9**,## 46.7**,## -2.38**,## -3.18**,## 

Dulaglutide 0.75 mg 
once weekly (n=302) 8.19 -1.01

‡‡,## 55.2**,## 31.0**,## -1.97**,## -2.63**,## 

Placebo (n= 177) 8.10 0.03 21.0 12.5 -0.49 -1.47 
Sitagliptin 
100 mg once daily 
(n=315) 

8.09 -0.61 37.8 21.8 -0.97 -1.46 

52 weeks 
Dulaglutide 1.5 mg 
once weekly (n=304) 8.12 -1.10

†† 57.6## 41.7## -2.38## -3.03## 

Dulaglutide 0.75 mg 
once weekly (n=302) 8.19 -0.87

†† 48.8## 29.0## -1.63## -2.60## 

Sitagliptin 100 mg 
once daily (n=315) 8.09 -0.39 33.0 19.2 -0.90 -1.53 

104 weeks 
Dulaglutide 1.5 mg 
once weekly (n=304) 8.12 -0.99

†† 54.3## 39.1## -1.99## -2.88## 

Dulaglutide 0.75 mg 
once weekly (n=302) 8.19 -0.71

†† 44.8## 24.2## -1.39## -2.39 

Sitagliptin 100 mg 
once daily (n=315) 8.09 -0.32 31.1 14.1 -0.47 -1.75 

†† multiplicity adjusted 1-sided p-value < 0.025, for superiority of dulaglutide compared to sitagliptin, 
assessed only for HbA1c at 52 and 104 weeks 

‡‡ multiplicity adjusted 1-sided p-value < 0.001 for superiority of dulaglutide compared to placebo, 
assessed for HbA1c only 

** p < 0.001 dulaglutide treatment group compared to placebo 
## p < 0.001 dulaglutide treatment group compared to sitagliptin 
 
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and 
sitagliptin were 0.19, 0.18, and 0.17 episodes/patient/year, respectively. No cases of severe 
hypoglycaemia with dulaglutide were observed. 
 
The safety and efficacy of dulaglutide was also investigated in an active controlled study (liraglutide 
1.8 mg daily) of 26 weeks duration, both in combination with metformin. Treatment with Trulicity 
1.5 mg resulted in similar lowering of HbA1c and patients achieving HbA1c targets of < 7.0 % and 
≤ 6.5 % compared to liraglutide.  



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Table 4: Results of a 26 week active controlled study of one dose of dulaglutide in comparison to 
liraglutide 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in 
body 

weight 
 (%) (%) <7.0 %(%) ≤6.5 %(%) (mmol/L) (kg) 

26 weeks 
Dulaglutide 1.5 mg 
once weekly (n=299) 8.06 

-1.42‡ 68.3 54.6 -1.93 -2.90# 

Liraglutide+ 1.8 mg 
daily (n=300) 8.05 

-1.36 67.9 50.9 -1.90 -3.61 
‡ 1-sided p-value p < 0.001, for noninferiority of dulaglutide compared to liraglutide, assessed only 

for HbA1c. 
# p < 0.05 dulaglutide treatment group compared to liraglutide. 
+ Patients randomised to liraglutide were initiated at a dose of 0.6 mg/day. After Week 1, patients 

were up-titrated to 1.2 mg/day and then at Week 2 to 1.8 mg/day. 
 
The rate of documented symptomatic hypoglycaemia with Trulicity 1.5 mg was 
0.12 episodes/patient/year and with liraglutide was 0.29 episodes/patient/year. No cases of severe 
hypoglycaemia were observed 
 
Combination therapy with metformin and sulphonylurea 
In an active controlled study of 78 weeks duration, dulaglutide was compared to insulin glargine, both 
on a background of metformin and a sulphonylurea. At 52 weeks, Trulicity 1.5 mg demonstrated 
superior lowering in HbA1c to insulin glargine which was maintained at 78 weeks; whereas lowering 
in HbA1c with Trulicity 0.75 mg was non-inferior to insulin glargine. With Trulicity 1.5 mg a 
significantly higher percentage of patients reached a target HbA1c of < 7.0 % or ≤ 6.5 % at 52 and 
78 weeks compared to insulin glargine.  
 
Table 5: Results of a 78 week active controlled study with two doses of dulaglutide in comparison to 
insulin glargine 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in 
body 

weight 
 (%) (%) <7.0% (%) ≤6.5% (%) (mmol/L) (kg) 

52 weeks 
Dulaglutide 1.5 mg 
once weekly (n=273) 8.18 -1.08

†† 53.2## 27.0## -1.50 -1.87## 

Dulaglutide 0.75 mg 
once weekly (n=272) 8.13 -0.76

† 37.1 22.5# -0.87## -1.33## 

Insulin glargine+ 
once daily (n=262) 8.10 -0.63 30.9 13.5 -1.76 1.44 

78 weeks 
Dulaglutide 1.5 mg 
once weekly (n=273) 8.18 -0.90

†† 49.0## 28.1## -1.10# -1.96## 

Dulaglutide 0.75 mg 
once weekly (n=272) 8.13 -0.62† 34.1 22.1 -0.58

## -1.54## 

Insulin glargine+ 
once daily (n=262) 8.10 -0.59 30.5 16.6 -1.58 1.28 

† multiplicity adjusted 1-sided p-value < 0.025, for noninferiority; †† multiplicity adjusted 1-sided 
p-value < 0.025, for superiority of dulaglutide to insulin glargine, assessed for HbA1c only 

# p < 0.05, ## p < 0.001 dulaglutide treatment group compared to insulin glargine  
+  Insulin glargine doses were adjusted utilising an algorithm with a fasting plasma glucose target of 

< 5.6 mmol/L 
 
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and insulin 
glargine were 1.67, 1.67, and 3.02 episodes/patient/year, respectively. Two cases of severe 



13 

hypoglycaemia were observed with Trulicity 1.5mg and two cases of severe hypoglycaemia were 
observed with insulin glargine. 
 
Combination therapy with sulphonylurea 
The safety and efficacy of dulaglutide as add-on to a sulphonylurea was investigated in a placebo 
controlled study of 24 weeks duration. Treatment with Trulicity 1.5mg in combination with 
glimepiride resulted in a statistically significant reduction in HbA1c compared to placebo with 
glimepiride at 24 weeks.   With Trulicity 1.5 mg, a significantly higher percentage of patients reached 
a target HbA1c of < 7.0 % and ≤ 6.5 % at 24 weeks compared to placebo.  
 
Table 6: Results of a 24 week placebo controlled study of dulaglutide as add-on to glimepiride 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in 
body 

weight 
 (%) (%) <7.0% (%) ≤6.5% (%) (mmol/L) (kg) 

24 weeks 
Dulaglutide 1.5 mg 
once weekly (n=239) 8.39 -1.38

‡‡ 55.3‡‡ 40.0** -1.70‡‡ -0.91 

Placebo (n=60) 8.39 -0.11 18.9 9.4 0.16 -0.24 
‡‡  p < 0.001 for superiority of dulaglutide compared to placebo, with overall type I error controlled 
** p < 0.001 for dulaglutide treatment group compared to placebo  
 
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and placebo were 0.90 
and 0.04 episodes/patient/year, respectively. No cases of severe hypoglycaemia were observed for 
Trulicity or placebo. 
 
Combination therapy with SGLT2 inhibitor with or without metformin  
The safety and efficacy of dulaglutide as add-on to sodium-glucose co-transporter 2 inhibitor 
(SGLT2i) therapy (96% with and 4% without metformin) were investigated in a placebo controlled 
study of 24 weeks duration. Treatment with Trulicity 0.75 mg or Trulicity 1.5 mg in combination with 
SGLT2i therapy resulted in a statistically significant reduction in HbA1c compared to placebo with 
SGLT2i therapy at 24 weeks. With both Trulicity 0.75 mg and 1.5 mg, a significantly higher 
percentage of patients reached a target HbA1c of < 7.0% and ≤ 6.5% at 24 weeks compared to 
placebo.  
 
Table 7: Results of a 24 week placebo controlled study of dulaglutide as add-on to SGLT2i therapy 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in 
body 

weight 
 (%) (%) <7.0%^ (%) ≤6.5% (%) (mmol/L) (kg) 

24 weeks 
Dulaglutide 0.75 mg 
once weekly (n=141) 8.05 -1.19

‡‡ 58.8‡‡ 38.9** -1.44 -2.6 

Dulaglutide 1.5 mg 
once weekly (n=142) 8.04 -1.33

‡‡ 67.4‡‡ 50.8** -1.77 -3.1 

Placebo (n=140) 8.05 -0.51 31.2 14.6 -0.29 -2.3 
‡‡  p < 0.001 for superiority of dulaglutide compared to placebo, with overall type I error controlled 
** p < 0.001 for dulaglutide treatment group compared to placebo  
^ Patients who withdrew from randomized treatment before 24 weeks were considered as not meeting 
the target 
 
The rates of documented symptomatic hypoglycaemia with Trulicity 0.75 mg, Trulicity 1.5 mg, and 
placebo were 0.15, 0.16 and 0.12 episodes/patient/year, respectively. One patient reported severe 
hypoglycaemia with Trulicity 0.75 mg in combination with SGLT2i therapy and none with Trulicity 
1.5 mg or placebo. 



14 

 
Combination therapy with metformin and pioglitazone 
In a placebo and active (exenatide twice daily) controlled study, both in combination with metformin 
and pioglitazone, Trulicity 1.5 mg and 0.75 mg demonstrated superiority for HbA1c reduction in 
comparison to placebo and exenatide, accompanied by a significantly a greater percentage of patients 
achieving HbA1c targets of < 7.0 % or ≤ 6.5 % 
 
Table 8: Results of a 52 week active controlled study with two doses of dulaglutide in comparison to 
exenatide 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in 
body 

weight 
 (%) (%) <7.0% (%) ≤6.5% (%) (mmol/L) (kg) 

26 weeks 
Dulaglutide 1.5 mg 
once weekly (n=279) 8.10 -1.51‡‡,

†† 78.2**,## 62.7**,## -2.36**,## -1.30** 

Dulaglutide 0.75 mg 
once weekly (n=280) 8.05 -1.30‡‡/

†† 65.8**/## 53.2**/## -1.90**/## 0.20 */## 

Placebo (n=141)  8.06 -0.46  42.9 24.4 -0.26 1.24 
Exenatide+ 
10 mcg twice daily 
(n=276) 

8.07 -0.99 52.3 38.0 -1.35 -1.07 

52 weeks 
Dulaglutide 1.5 mg 
once weekly (n=279) 8.10 -1.36

†† 70.8## 57.2## -2.04## -1.10 

Dulaglutide 0.75 mg 
once weekly (n=280) 8.05 -1.07

†† 59.1# 48.3## -1.58# 0.44# 

Exenatide+ 
10 mcg twice daily 
(n=276) 

8.07 -0.80 49.2 34.6 -1.03 -0.80 

†† multiplicity adjusted 1-sided p-value < 0.025, for superiority of dulaglutide to exenatide, assessed 
for HbA1c only 
‡‡ multiplicity adjusted 1-sided p-value < 0.001 for superiority of dulaglutide compared to placebo, 
assessed for HbA1c only 
* p < 0.05, **p < 0.001 dulaglutide treatment group compared to placebo 
# p < 0.05, ##p < 0.001 dulaglutide treatment group compared to exenatide 
+ Exenatide dose was 5 mcg twice daily for first 4 weeks and 10 mcg twice daily thereafter 
 
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and 
exenatide twice daily were 0.19, 0.14, and 0.75 episodes/patient/year, respectively. No cases of severe 
hypoglycaemia were observed for dulaglutide and two cases of severe hypoglycaemia were observed 
with exenatide twice daily. 
 
Combination therapy with titrated basal insulin, with or without metformin 
In a 28 week placebo controlled study, Trulicity1.5 mg was compared to placebo as add-on to titrated 
basal insulin glargine (88% with and 12% without metformin) to evaluate the effect on glycaemic 
control and safety. To optimise the insulin glargine dose, both groups were titrated to a target fasting 
serum glucose of <5.6 mmol/L. The mean baseline dose of insulin glargine was 37 units/day for 
patients receiving placebo and 41 units/day for patients receiving Trulicity 1.5mg.  The initial insulin 
glargine doses in patients with HbA1c <8.0% were reduced by 20%. At the end of the 28 week 
treatment period the dose was 65 units/day and 51 units/day, for patients receiving placebo and 
Trulicity 1.5 mg, respectively. At 28 weeks, treatment with once weekly Trulicity 1.5 mg resulted in a 
statistically significant reduction in HbA1c compared to placebo and a significantly greater percentage 
of patients achieving HbA1c targets of < 7.0 % and ≤ 6.5 % (Table 9). 
 



15 

Table 9: Results of a 28 week study of dulaglutide compared to placebo as add-on to titrated insulin 
glargine 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in 
body 

weight 
 (%) (%) <7.0% (%) ≤6.5% (%) (mmol/L) (kg) 

28 weeks 
Dulaglutide 1.5 mg 
once weekly and 
insulin glargine 
(n=150) 

8.41 -1.44‡‡ 66.7‡‡ 50.0** -2.48‡‡ -1.91‡‡ 

Placebo once weekly 
and insulin glargine 
(n=150) 

8.32 -0.67 33.3 16.7 -1.55 0.50 

‡‡  p < 0.001 for superiority of dulaglutide compared to placebo, overall type I error controlled 
** p < 0.001 dulaglutide treatment group compared to placebo 
 
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and insulin glargine were 
3.38 episodes/patient/year compared to placebo and insulin glargine 4.38 episodes/patient/year.  One 
patient reported severe hypoglycaemia with Trulicity 1.5 mg in combination with insulin glargine and 
none with placebo. 
 
Combination therapy with prandial insulin with or without metformin 
In this study, patients on 1 or 2 insulin injections per day prior to study entry, discontinued their 
prestudy insulin regimen and were randomised to dulaglutide once weekly or insulin glargine once 
daily, both in combination with prandial insulin lispro three times daily, with or without metformin. At 
26 weeks, both Trulicity 1.5 mg and 0.75mg were superior to insulin glargine in lowering of HbA1c 
and this effect was sustained at 52 weeks. A greater percentage of patients achieved HbA1c targets of 
< 7.0 % or ≤ 6.5 % at 26 weeks and < 7.0 % at 52 weeks than with insulin glargine.  
 
Table 10: Results of a 52 week active controlled study with two doses of dulaglutide in comparison to 
insulin glargine 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in 
body 

weight 
 (%) (%) <7.0% (%) ≤6.5% (%) (mmol/L) (kg) 

26 weeks 
Dulaglutide 1.5 mg 
once weekly (n=295) 8.46 -1.64

†† 67.6# 48.0# -0.27## -0.87## 

Dulaglutide 0.75 mg 
once weekly (n=293) 8.40 -1.59

†† 69.0# 43.0 0.22## 0.18## 

Insulin glargine+ 
once daily (n=296) 8.53 -1.41 56.8 37.5 -1.58 2.33 

52 weeks 
Dulaglutide 1.5 mg 
once weekly (n=295) 8.46 -1.48

†† 58.5# 36.7 0.08## -0.35## 

Dulaglutide 0.75 mg 
once weekly (n=293) 8.40 -1.42

†† 56.3 34.7 0.41## 0.86## 

Insulin glargine+ 
once daily (n=296) 8.53 -1.23 49.3 30.4 -1.01 2.89 

†† multiplicity adjusted 1-sided p-value < 0.025, for superiority of dulaglutide to insulin glargine, 
assessed for HbA1c only 

# p < 0.05, ## p < 0.001 dulaglutide treatment group compared to insulin glargine 
+ Insulin glargine doses were adjusted utilizing an algorithm with a fasting plasma glucose target of 

< 5.6 mmol/L 
 



16 

The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and insulin 
glargine were 31.06, 35.66, and 40.95 episodes/patient/year, respectively. Ten patients reported severe 
hypoglycaemia with Trulicity 1.5 mg, seven with Trulicity 0.75 mg, and fifteen with insulin glargine. 
 
Fasting blood glucose 
Treatment with dulaglutide resulted in significant reductions from baseline in fasting blood glucose. 
The majority of the effect on fasting blood glucose concentrations occurred by 2 weeks. The 
improvement in fasting glucose was sustained through the longest study duration of 104 weeks. 
 
Postprandial glucose 
Treatment with dulaglutide resulted in significant reductions in mean post prandial glucose from 
baseline (changes from baseline to primary time point -1.95 mmol/L to -4.23 mmol/L). 
 
Beta-cell function 
Clinical studies with dulaglutide have indicated enhanced beta-cell function as measured by 
homeostasis model assessment (HOMA2-%B). The durability of effect on beta-cell function was 
maintained through the longest study duration of 104 weeks. 
 
Body weight 
Trulicity 1.5 mg was associated with sustained weight reduction over the duration of studies (from 
baseline to final time point -0.35 kg to -2.90 kg). Changes in body weight with Trulicity 0.75 mg 
ranged from 0.86 kg to -2.63 kg. Reduction in body weight was observed in patients treated with 
dulaglutide irrespective of nausea, though the reduction was numerically larger in the group with 
nausea. 
 
Patient reported outcomes 
Dulaglutide significantly improved total treatment satisfaction compared to exenatide twice daily. In 
addition, there was significantly lower perceived frequency of hyperglycaemia and hypoglycaemia 
compared to exenatide twice daily. 
 
Blood pressure 
The effect of dulaglutide on blood pressure as assessed by Ambulatory Blood Pressure Monitoring 
was evaluated in a study of 755 patients with type 2 diabetes. Treatment with dulaglutide provided 
reductions in systolic blood pressure (SBP) (-2.8 mmHg difference compared to placebo) at 16 weeks. 
There was no difference in diastolic blood pressure (DBP). Similar results for SBP and DBP were 
demonstrated at the final 26 week time point of the study. 
 
Cardiovascular Evaluation 
 
Meta-analysis of phase II and III studies 
In a meta-analysis of phase II and III registration studies, a total of 51 patients (dulaglutide: 
26 [N = 3,885]; all comparators: 25 [N = 2,125]) experienced at least one cardiovascular (CV) event 
(death due to CV causes, nonfatal MI, nonfatal stroke, or hospitalisation for unstable angina). The 
results showed that there was no increase in CV risk with dulaglutide compared with control therapies 
(HR: 0.57; CI: [0.30, 1.10]). 
 
Cardiovascular outcome study 
The Trulicity long-term cardiovascular outcome study was a placebo-controlled, double-blind clinical 
trial. Type 2 diabetes patients were randomly allocated to either Trulicity 1.5 mg (4,949) or placebo 
(4,952) both in addition to standards of care for type 2 diabetes (the 0.75 mg dose was not 
administered in this study). The median study follow-up time was 5.4 years.  
 
The mean age was 66.2 years, the mean BMI was 32.3 kg/m², and 46.3 % of patients were female. 
There were 3,114 (31.5 %) patients with established CV disease. The median baseline HbA1c was 
7.2 %. The Trulicity treatment arm included patients ≥ 65 years (n = 2,619) and ≥ 75 years (n = 484), 
and patients with mild (n = 2,435), moderate (n = 1,031) or severe (n = 50) renal impairment.  
 



17 

The primary endpoint was the time from randomisation to first occurrence of any major adverse 
cardiovascular events (MACE): CV death, non-fatal myocardial infarction, or non-fatal stroke. 
Trulicity was superior in preventing MACE compared to placebo (Figure 1). Each MACE component 
contributed to the reduction of MACE, as shown in Figure 2. 
 
 

 
 
Figure 1. Kaplan-Meier plot of time to first occurrence of the composite outcome: CV death, non-fatal 
myocardial infarction or non-fatal stroke, in the dulaglutide long-term cardiovascular outcome study 
 



18 

 

 
 
Figure 2: Forest plot of analyses of individual cardiovascular event types, all cause death, and 
consistency of effect across subgroups for the primary endpoint  
 
A significant and sustained reduction in HbA1c levels from baseline to month 60 was observed with 
Trulicity vs placebo, in addition to standard of care (-0.29 % vs 0.22 %; estimated treatment 
difference -0.51 % [-0.57; -0.45]; p < 0.001). There were significantly fewer patients in the Trulicity 
group who received an additional glycaemic intervention compared to placebo (Trulicity: 2,086 
[42.2 %]; placebo: 2,825 [57.0 %]; p < 0.001). 
 
Special populations 
 
Use in patients with renal impairment 
In a 52 week study, Trulicity 1.5 mg and 0.75 mg were compared to titrated insulin glargine as add-on 
to prandial insulin lispro to evaluate the effect on glycaemic control and safety of patients with 
moderate to severe chronic kidney disease (eGFR [by CKD-EPI] <60 and ≥15 mL/min/1.73 m2). 



19 

Patients discontinued their prestudy insulin regimen at randomisation.  At baseline, overall mean 
eGFR was 38 mL/min/1.73 m2, 30% of patients had eGFR < 30 mL/min/1.73 m2. 
 
At 26 weeks, both Trulicity 1.5 mg and 0.75 mg were non-inferior to insulin glargine in lowering of 
HbA1c and this effect was sustained at 52 weeks. A similar percentage of patients achieved HbA1c 
targets of < 8.0 % at 26 and 52 weeks with both dulaglutide doses as well as insulin glargine. 
 
Table 11: Results of a 52 week active controlled study with two doses of dulaglutide in comparison to 
insulin glargine (in patients with moderate to severe chronic kidney disease) 
 

 Baseline 
HbA1c 

Mean change 
in HbA1c 

Patients at 
target 
HbA1c 

Change in 
FBG 

 

Change in 
body weight 

 

 (%) (%) <8.0% (%) (mmol/L) (kg) 
26 weeks 
Dulaglutide 1.5 mg 
once weekly (n=192) 8.60 -1.19

† 78.3 1.28## -2.81## 

Dulaglutide 0.75 mg 
once weekly (n=190) 8.58 -1.12

† 72.6 0.98## -2.02## 

Insulin glargine+ 
once daily (n=194) 8.56 -1.13 75.3 -1.06 1.11 

52 weeks 
Dulaglutide 1.5 mg 
once weekly (n=192) 8.60 -1.10

† 69.1 1.57## -2.66## 

Dulaglutide 0.75 mg 
once weekly (n=190) 8.58 -1.10

† 69.5 1.15## -1.71## 

Insulin glargine+ 
once daily (n=194) 8.56 -1.00 70.3 -0.35 1.57 

† 1-sided p-value < 0.025, for non-inferiority of dulaglutide to insulin glargine 
##  p < 0.001 dulaglutide treatment group compared to insulin glargine 
+ Insulin glargine doses were adjusted utilizing an algorithm with a fasting plasma glucose target of 

≤ 8.3 mmol/L 
 
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and Trulicity 0.75 mg, 
and insulin glargine were 4.44, 4.34, and 9.62 episodes/patient/year, respectively. No patients reported 
cases of severe hypoglycaemia with Trulicity 1.5 mg, six with Trulicity 0.75 mg, and seventeen with 
insulin glargine. The safety profile of Trulicity in patients with renal impairment was similar to that 
observed in other studies with Trulicity. 
 
Paediatric population 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Trulicity in one or more subsets of the paediatric population for the treatment of type 2 diabetes 
mellitus (see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
Following subcutaneous administration to patients with type 2 diabetes, dulaglutide reaches peak 
plasma concentrations in 48 hours. The mean peak (Cmax) and total (AUC) exposures were 
approximately 114 ng/ml and 14,000 ngh/ml, respectively, after multiple subcutaneous 1.5 mg doses 
of dulaglutide in patients with type 2 diabetes. Steady-state plasma concentrations were achieved 
between 2 to 4 weeks of once-weekly administration of dulaglutide (1.5 mg). Exposures after 
subcutaneous administration of single dulaglutide (1.5 mg) doses in the abdomen, thigh, or upper arm 
were comparable. The mean absolute bioavailability of dulaglutide following single-dose 
subcutaneous administration of single 1.5 mg and 0.75 mg doses was 47 % and 65%, respectively. 
 



20 

Distribution 
The mean volume of distribution after subcutaneous administration of dulaglutide 0.75 mg and 1.5 mg 
at steady state in patients with type 2 diabetes mellitus were approximately 19.2 L and 17.4 L. 
 
Biotransformation  
Dulaglutide is presumed to be degraded into its component amino acids by general protein catabolism 
pathways. 
 
Elimination 
The mean apparent clearance of dulaglutide 0.75 mg and 1.5 mg at steady state was 0.111  L/h and 
0.107 L/h with an elimination half-life of 4.5 and 4.7 days, respectively. 
 
Special populations 
 
Elderly 
Age had no clinically relevant effect on the pharmacokinetic and pharmacodynamic properties of 
dulaglutide. 
 
Gender and race 
Gender and race had no clinically meaningful effect on the pharmacokinetics of dulaglutide. 
 
Body weight or body mass index 
Pharmacokinetic analyses have demonstrated a statistically significant inverse relationship between 
body weight or body mass index (BMI) and dulaglutide exposure, although there was no clinically 
relevant impact of weight or BMI on glycaemic control. 
 
Renal impairment 
The pharmacokinetics of dulaglutide were evaluated in a clinical pharmacology study and were 
generally similar between healthy subjects and patients with mild to severe renal impairment 
(CrCl < 30 ml/min), including end stage renal disease (requiring dialysis). Additionally, in a 52-week 
clinical study in patients with type 2 diabetes and moderate to severe renal impairment (eGFR [by 
CKD-EPI] <60 and ≥15 mL/min/1.73 m2), the pharmacokinetic profile of Trulicity 0.75 mg and 1.5 
mg once weekly was similar to that demonstrated in previous clinical studies. This clinical study did 
not include patients with end stage renal disease. 
 
Hepatic impairment 
The pharmacokinetics of dulaglutide were evaluated in a clinical pharmacology study, where subjects 
with hepatic impairment had statistically significant decreases in dulaglutide exposure of up to 30 % to 
33 % for mean Cmax and AUC, respectively, compared to healthy controls. There was a general 
increase in tmax of dulaglutide with increased hepatic impairment. However, no trend in dulaglutide 
exposure was observed relative to the degree of hepatic impairment. These effects were not considered 
to be clinically relevant. 
 
Paediatric population 
Studies characterising the pharmacokinetics of dulaglutide in paediatric patients have not been 
performed. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazards for humans based on conventional studies of safety 
pharmacology or repeat-dose toxicity. 
 
In a 6-month carcinogenicity study in transgenic mice, there was no tumorigenic response. In a 2-year 
carcinogenicity study in rats, at ≥ 7 times the human clinical exposure following 1.5 mg dulaglutide 
per week, dulaglutide caused statistically significant, dose-related increases in the incidence of thyroid 
C-cell tumours (adenomas and carcinomas combined). The clinical relevance of these findings is 
currently unknown.  



21 

 
During the fertility studies, a reduction in the number of corpora lutea and prolonged oestrous cycle 
were observed at dose levels that were associated with decreased food intake and body weight gain in 
maternal animals; however, no effects on indices of fertility and conception or embryonic 
development were observed. In reproductive toxicology studies, skeletal effects and a reduction in 
foetal growth were observed in the rat and rabbit at exposures of dulaglutide 11- to 44-fold higher than 
those proposed clinically, but no foetal malformations were observed. Treatment of rats throughout 
pregnancy and lactation produced memory deficits in female offspring at exposures that were 16-fold 
higher than those proposed clinically. Dulaglutide dosing of male and female juvenile rats did not 
produce memory deficits at 91-fold the human exposure.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium citrate 
Citric acid, anhydrous  
Mannitol 
Polysorbate 80 
Water for injections 
 
6.2  Incompatibilities 
 
In the absence of compatibility studies this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
2 years 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2ºC – 8ºC). 
Do not freeze. 
Store in original package in order to protect from light. 
 
In-use: 
Trulicity may be stored unrefrigerated for up to 14 days at a temperature not above 30ºC. 
 
6.5 Nature and contents of container 
 
Glass syringe (type I) encased in a disposable pen. 
Each pre-filled pen contains 0.5 ml of solution. 
Packs of 2 and 4 pre-filled pens and multipack of 12 (3 packs of 4) pre-filled pens. Not all pack sizes 
may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
Instructions for use 
The pre-filled pen is for single-use only. 
The instructions for using the pen, included with the package leaflet, must be followed carefully. 
Trulicity should not be used if particles appear or if the solution is cloudy and/or discoloured. 
Trulicity that has been frozen must not be used. 



22 

 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
 
8. MARKETING AUTHORISATION NUMBER 
 
EU/1/14/956/001 
EU/1/14/956/002 
EU/1/14/956/003 
EU/1/14/956/006 
EU/1/14/956/007 
EU/1/14/956/008 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 21 November 2014 
Date of latest renewal: 23 August 2019 
 
 
10. DATE OF REVISION OF THE TEXT  
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 

http://www.ema.europa.eu/


23 

1. NAME OF THE MEDICINAL PRODUCT  
 
Trulicity 0.75 mg solution for injection in pre-filled syringe 
Trulicity 1.5 mg solution for injection in pre-filled syringe 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Trulicity 0.75 mg solution for injection 
Each pre-filled syringe contains 0.75 mg of dulaglutide* in 0.5 ml solution. 
 
Trulicity 1.5 mg solution for injection 
Each pre-filled syringe contains 1.5 mg of dulaglutide* in 0.5 ml solution. 
 
*Produced in CHO cells by recombinant DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection.  
Clear, colourless solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Type 2 Diabetes Mellitus 
 
Trulicity is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus 
as an adjunct to diet and exercise 

• as monotherapy when metformin is considered inappropriate due to intolerance or 
contraindications 

• in addition to other medicinal products for the treatment of diabetes. 
For study results with respect to combinations, effects on glycaemic control and cardiovascular events, 
and the populations studied, see sections 4.4, 4.5 and 5.1. 
 
4.2  Posology and method of administration 
 
Posology 
 
Monotherapy  
The recommended dose is 0.75 mg once weekly. 
 
Add-on therapy 
The recommended dose is 1.5 mg once weekly. 
For potentially vulnerable populations 0.75 mg once weekly can be considered as a starting dose.  
 
When Trulicity is added to existing metformin and/or pioglitazone therapy, the current dose of 
metformin and/or pioglitazone can be continued. When Trulicity is added to existing metformin and/or 
sodium-glucose co-transporter 2 inhibitor (SGLT2i) therapy, the current dose of metformin and/or 
SGLT2i can be continued. When it is added to existing therapy of a sulphonylurea or insulin, a 
reduction in the dose of sulphonylurea or insulin may be considered to reduce the risk of 
hypoglycaemia (see sections 4.4 and 4.8). 
 



24 

The use of Trulicity does not require blood glucose self-monitoring. Blood glucose self-monitoring is 
necessary to adjust the dose of sulphonylurea or insulin, particularly when Trulicity therapy is started 
and insulin is reduced. A stepwise approach to insulin dose reduction is recommended. 
 
Elderly 
No dose adjustment is required based on age (see section 5.2). 
 
Renal impairment 
No dosage adjustment is required in patients with mild, moderate or severe renal impairment (eGFR 
<90 to ≥15 mL/min/1.73m2). 
 
There is very limited experience in patients with end stage renal disease (<15 ml/min/1.73m2), 
therefore Trulicity cannot be recommended in this population (see sections 5.1 and 5.2). 
 
Hepatic impairment 
No dosage adjustment is required in patients with hepatic impairment. 
 
Paediatric population 
The safety and efficacy of dulaglutide in children aged less than 18 years have not yet been 
established. No data are available. 
 
Method of administration 
 
Trulicity is to be injected subcutaneously in the abdomen, thigh or upper arm. It should not be 
administered intravenously or intramuscularly. 
 
The dose can be administered at any time of day, with or without meals.  
 
If a dose is missed, it should be administered as soon as possible if there are at least 3 days (72 hours) 
until the next scheduled dose. If less than 3 days (72 hours) remain before the next scheduled dose, the 
missed dose should be skipped and the next dose should be administered on the regularly scheduled 
day. In each case, patients can then resume their regular once weekly dosing schedule. 
 
The day of weekly administration can be changed if necessary, as long as the last dose was 
administered 3 or more days (72 hours) before. 
 
4.3 Contraindications  
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use  
 
Dulaglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic 
ketoacidosis. Dulaglutide is not a substitute for insulin. Diabetic ketoacidosis has been reported in 
insulin-dependent patients after rapid discontinuation or dose reduction of insulin (see section 4.2). 
 
Dehydration 
Dehydration, sometimes leading to acute renal failure or worsening renal impairment, has been 
reported in patients treated with dulaglutide, especially at the initiation of treatment. Many of the 
reported adverse renal events occurred in patients who had experienced nausea, vomiting, diarrhoea, 
or dehydration. Patients treated with dulaglutide should be advised of the potential risk of dehydration, 
particularly in relation to gastrointestinal side-effects and take precautions to avoid fluid depletion. 
 
Dulaglutide has not been studied in patients with severe gastrointestinal disease, including severe 
gastroparesis, and is therefore not recommended in these patients. 
 
Acute pancreatitis 



25 

Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis. In 
clinical trials, acute pancreatitis has been reported in association with dulaglutide (see section 4.8). 
 
Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is 
suspected, dulaglutide should be discontinued. If pancreatitis is confirmed, dulaglutide should not be 
restarted. In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic 
enzymes alone are not predictive of acute pancreatitis (see section 4.8). 
 
Hypoglycaemia 
Patients receiving dulaglutide in combination with sulphonylurea or insulin may have an increased 
risk of hypoglycaemia. The risk of hypoglycaemia may be lowered by a reduction in the dose of 
sulphonylurea or insulin (see sections 4.2 and 4.8). 
 
Sodium content 
This medicinal product contains less than 1 mmol sodium (23 mg) per 1.5 mg dose, i.e. essentially 
‘sodium- free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Dulaglutide delays gastric emptying and has the potential to impact the rate of absorption of 
concomitantly administered oral medicinal products. In the clinical pharmacology studies described 
below, dulaglutide did not affect the absorption of the orally administered medications tested to any 
clinically relevant degree. However, for patients receiving oral medicinal products requiring rapid 
gastrointestinal absorption or prolonged release formulations the potential for altered drug exposure 
should be considered.  
 
Sitagliptin 
Sitagliptin exposure was unaffected when coadministered with a single dose of dulaglutide. Following 
coadministration with 2 consecutive doses of dulaglutide, sitagliptin AUC(0-τ) and Cmax decreased by 
approximately 7.4 % and 23.1 %, respectively. Sitagliptin tmax increased approximately 0.5 hours 
following coadministration with dulaglutide compared to sitagliptin alone. 
 
Sitagliptin can produce up to 80 % inhibition of DPP-4 over a 24-hour period. Dulaglutide 
coadministration with sitagliptin increased dulaglutide exposure and Cmax by approximately 38 % and 
27 %, respectively, and median tmax increased approximately 24 hours. Therefore, dulaglutide does 
have a high degree of protection against DPP-4 inactivation (see section 5.1, Mechanism of action). 
The increased exposure may enhance the effects of dulaglutide on blood glucose levels. 
 
Paracetamol 
Following a first dose of 1 and 3 mg dulaglutide, paracetamol Cmax was reduced by 36 % and 50 %, 
respectively, and the median tmax occurred later (3 and 4 hours, respectively). After coadministration 
with up to 3 mg of dulaglutide at steady state, there were no statistically significant differences on 
AUC(0-12), Cmax or tmax of paracetamol. No dose adjustment of paracetamol is necessary when 
administered with dulaglutide. 
 
Atorvastatin 
Coadministration of dulaglutide with atorvastatin decreased Cmax and AUC(0-∞) up to 70 % and 21 %, 
respectively, for atorvastatin and its major metabolite o-hydroxyatorvastatin. The mean t1/2 of 
atorvastatin and o-hydroxyatorvastatin were increased by 17 % and 41 %, respectively, following 
dulaglutide administration. These observations are not clinically relevant. No dose adjustment of 
atorvastatin is necessary when administered with dulaglutide. 
 
Digoxin  
After coadministration of steady state digoxin with 2 consecutive doses of dulaglutide, overall 
exposure (AUCτ) and tmax of digoxin were unchanged; and Cmax decreased by up to 22 %. This change 
is not expected to have clinical consequences. No dose adjustment is required for digoxin when 
administered with dulaglutide. 



26 

 
Anti-hypertensives 
Coadministration of multiple dulaglutide doses with steady state lisinopril caused no clinically 
relevant changes in the AUC or Cmax of lisinopril. Statistically significant delays in lisinopril tmax of 
approximately 1 hour were observed on Days 3 and 24 of the study. When a single dose of dulaglutide 
and metoprolol were coadministered, the AUC and Cmax of metoprolol increased by19 % and 32 %, 
respectively. While metoprolol tmax was delayed by 1 hour, this change was not statistically significant. 
These changes were not clinically relevant; therefore no dose adjustment of lisinopril or metoprolol is 
necessary when administered with dulaglutide. 
 
Warfarin  
Following dulaglutide coadministration, S- and R-warfarin exposure and R-warfarin Cmax were 
unaffected, and S-warfarin Cmax decreased by 22 %. AUCINR increased by 2 %, which is unlikely to be 
clinically significant, and there was no effect on maximum international normalised ratio response 
(INRmax). The time of international normalised ratio response (tINRmax) was delayed by 6 hours, 
consistent with delays in tmax of approximately 4 and 6 hours for S- and R-warfarin, respectively. 
These changes are not clinically relevant. No dose adjustment for warfarin is necessary when given 
together with dulaglutide. 
 
Oral contraceptives 
Coadministration of dulaglutide with an oral contraceptive (norgestimate 0.18 mg/ethinyl estradiol 
0.025 mg) did not affect the overall exposure to norelgestromin and ethinyl estradiol. Statistically 
significant reductions in Cmax of 26 % and 13 % and delays in tmax of 2 and 0.30 hours were observed 
for norelgestromin and ethinyl estradiol, respectively. These observations are not clinically relevant. 
No dose adjustment for oral contraceptives is required when given together with dulaglutide. 
 
Metformin 
Following coadministration of multiple dose dulaglutide with steady state metformin (immediate 
release formula [IR]), metformin AUCτ increased up to 15 % and Cmax decreased up to 12 %, 
respectively, with no changes in tmax. These changes are consistent with the gastric emptying delay of 
dulaglutide and within the pharmacokinetic variability of metformin and thus are not clinically 
relevant. No dose adjustment for metformin IR is recommended when given with dulaglutide. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no or limited amount of data from the use of dulaglutide in pregnant women. Studies in 
animals have shown reproductive toxicity (see section 5.3). Therefore, the use of dulaglutide is not 
recommended during pregnancy. 
 
Breast-feeding 
It is unknown whether dulaglutide is excreted in human milk. A risk to newborns/infants cannot be 
excluded. Dulaglutide should not be used during breast-feeding. 
 
Fertility 
The effect of dulaglutide on fertility in humans is unknown. In the rat, there was no direct effect on 
mating or fertility following treatment with dulaglutide (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Trulicity has no or negligible influence on the ability to drive or use machines. When it is used in 
combination with a sulphonylurea or insulin, patients should be advised to take precautions to avoid 
hypoglycaemia while driving and using machines (see section 4.4). 
 



27 

4.8 Undesirable effects  
 
Summary of safety profile 
In the completed phase II and phase III initial registration studies, 4,006 patients were exposed to 
dulaglutide alone or in combination with other glucose lowering medicinal products. The most 
frequently reported adverse reactions in clinical trials were gastrointestinal, including nausea, 
vomiting and diarrhoea. In general these reactions were mild or moderate in severity and transient in 
nature. Results from the long-term cardiovascular outcome study with 4949 patients randomised to 
dulaglutide and followed for a median of 5.4 years were consistent with these findings. 
 
Tabulated list of adverse reactions 
The following adverse reactions have been identified based on evaluation of the full duration of the 
phase II and phase III clinical studies, the long-term cardiovascular outcome study and post-marketing 
reports. The adverse reactions are listed in Table 1 as MedDRA preferred term by system organ class 
and in order of decreasing incidence (very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: 
≥ 1/1,000 to < 1/100; rare: ≥ 1/10,000 to < 1/1,000; very rare: < 1/10,000 and not known: cannot be 
estimated from available data). Within each incidence grouping, adverse reactions are presented in 
order of decreasing frequency. Frequencies for events have been calculated based on their incidence in 
the phase II and phase III registration studies. 
 
Table 1: The frequency of adverse reactions of dulaglutide 
 

System Organ 
Class 

 

Very common Common 
 

Uncommon 
 

Rare Not 
known 

Immune system 
disorders  

  Hypersensitivity 
 

Anaphylactic 
reaction# 

 

Metabolism 
and nutrition 
disorders 

Hypoglycaemia* 
(when used in 
combination 
with insulin, 
glimepiride, 
metformin† or 
metformin plus 
glimepiride) 

Hypoglycaemia* 
(when used as 
monotherapy or 
in combination 
with metformin 
plus 
pioglitazone) 

Dehydration   

Gastrointestinal 
disorders 

Nausea, 
diarrhoea, 
vomiting†, 
abdominal pain† 

Decreased 
appetite, 
dyspepsia, 
constipation, 
flatulence, 
abdominal 
distention, 
gastroesophageal 
reflux disease, 
eructation 

 Acute 
pancreatitis 

Non-
mechanical 
intestinal 
obstruction 

Hepatobiliary 
disorders 

  Cholelithiasis, 
cholecystitis 

  

Skin and 
subcutaneous 
tissue disorders 

   Angioedema#  

General 
disorders and 
administration 
site conditions 

 Fatigue Injection site 
reactions 

  

Investigations  Sinus 
tachycardia, first 
degree 

   



28 

# From post-marketing reports.  
* Documented, symptomatic hypoglycaemia with blood glucose ≤ 3.9 mmol/L 
† Dulaglutide 1.5 mg dose only. For dulaglutide 0.75 mg, adverse reaction met frequency for next 
lower incidence grouping. 
 
Description of selected adverse reactions 
 
Hypoglycaemia 
When dulaglutide 0.75 mg and 1.5 mg were used as monotherapy or in combination with metformin 
alone or metformin and pioglitazone, the incidences of documented symptomatic hypoglycaemia were 
5.9% to 10.9% and the rates were 0.14 to 0.62 events/patient/year, and no episodes of severe 
hypoglycaemia were reported. 
 
The incidences of documented symptomatic hypoglycaemia when dulaglutide 0.75 mg and 1.5 mg, 
respectively, were used in combination with a sulphonylurea and metformin were 39.0% and 40.3% 
and the rates were 1.67 and 1.67 events/patient/year. The severe hypoglycaemia event incidences were 
0% and 0.7%, and rates were 0.00 and 0.01 events/patient/year for each dose, respectively. The 
incidence of documented symptomatic hypoglycaemia when dulaglutide 1.5 mg was used with 
sulphonylurea alone was 11.3% and the rate was 0.90 events/patient/year, and there were no episodes 
of severe hypoglycaemia. 
 
The incidence of documented symptomatic hypoglycaemia when dulaglutide 1.5 mg was used in 
combination with insulin glargine was 35.3% and the rate was 3.38 events/patient/year. The severe 
hypoglycaemia event incidence was 0.7% and the rate was 0.01 events/patient/year. 
 
The incidences when dulaglutide 0.75 mg and 1.5 mg, respectively, were used in combination with 
prandial insulin were 85.3% and 80.0% and rates were 35.66 and 31.06 events/patient/year. The severe 
hypoglycaemia event incidences were 2.4% and 3.4%, and rates were 0.05 and 
0.06 events/patient/year. 
 
Gastrointestinal adverse reactions 
Cumulative reporting of gastrointestinal events up to 104 weeks with dulaglutide 0.75mg and 1.5 mg, 
respectively, included nausea (12.9% and 21.2 %), diarrhoea (10.7% and 13.7 %) and vomiting (6.9% 
and 11.5 %). These were typically mild or moderate in severity and were reported to peak during the 
first 2 weeks of treatment and rapidly declined over the next 4 weeks, after which the rate remained 
relatively constant. 
 
In clinical pharmacology studies conducted in patients with type 2 diabetes mellitus up to 6 weeks, the 
majority of gastrointestinal events were reported during the first 2-3 days after the initial dose and 
declined with subsequent doses. 
 
Acute pancreatitis  
The incidence of acute pancreatitis in Phase II and III clinical studies was 0.07% for dulaglutide 
compared to 0.14% for placebo and 0.19% for comparators with or without additional background 
antidiabetic therapy. 
 
Pancreatic enzymes 
Dulaglutide is associated with mean increases from baseline in pancreatic enzymes (lipase and/or 
pancreatic amylase) of 11 % to 21 % (see section 4.4). In the absence of other signs and symptoms of 
acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis. 
 
Heart rate increase  
Small mean increases in heart rate of 2 to 4 beats per minute (bpm) and a 1.3% and 1.4 % incidence of 
sinus tachycardia, with a concomitant increase from baseline ≥ 15 bpm, were observed with 
dulaglutide 0.75mg and 1.5 mg, respectively. 

atrioventricular 
block (AVB) 



29 

 
First degree AV block/PR interval prolongation  
Small mean increases from baseline in PR interval of 2 to 3 msec and a 1.5% and 2.4 % incidence of 
first-degree AV block were observed with dulaglutide 0.75 mg and 1.5 mg, respectively. 
 
Immunogenicity  
In clinical studies, treatment with dulaglutide was associated with a 1.6 % incidence of treatment 
emergent dulaglutide anti-drug antibodies, indicating that the structural modifications in the GLP-1 
and modified IgG4 parts of the dulaglutide molecule, together with high homology with native GLP-1 
and native IgG4, minimise the risk of immune response against dulaglutide. Patients with dulaglutide 
anti-drug antibodies generally had low titres, and although the number of patients developing 
dulaglutide anti-drug antibodies was low, examination of the phase III data revealed no clear impact of 
dulaglutide anti-drug antibodies on changes in HbA1c. None of the patients with systemic 
hypersensitivity developed dulaglutide anti-drug antibodies. 
 
Hypersensitivity  
In the phase II and phase III clinical studies, systemic hypersensitivity events (e.g., urticaria, edema) 
were reported in 0.5 % of patients receiving dulaglutide. Cases of anaphylactic reaction have been 
rarely reported with marketed use of dulaglutide.  
 
Injection site reactions  
Injection site adverse events were reported in 1.9 % of patients receiving dulaglutide. Potentially 
immune-mediated injection site adverse events (e.g., rash, erythema) were reported in 0.7 % of 
patients and were usually mild. 
 
Discontinuation due to an adverse event 
In studies of 26 weeks duration, the incidence of discontinuation due to adverse events was 2.6% 
(0.75 mg) and 6.1% (1.5 mg) for dulaglutide versus 3.7 % for placebo. Through the full study duration 
(up to 104 weeks), the incidence of discontinuation due to adverse events was 5.1% (0.75 mg) and 
8.4 % (1.5 mg) for dulaglutide. The most frequent adverse reactions leading to discontinuation for 
0.75 mg and 1.5 mg dulaglutide, respectively, were nausea (1.0%, 1.9 %), diarrhoea (0.5%, 0.6 %), 
and vomiting (0.4%, 0.6 %), and were generally reported within the first 4-6 weeks. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Effects of overdose with dulaglutide in clinical studies have included gastrointestinal disorders and 
hypoglycaemia. In the event of overdose, appropriate supportive treatment should be initiated 
according to the patient’s clinical signs and symptoms. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties  
 
Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins, 
ATC code: A10BJ05 
 
Mechanism of action 
Dulaglutide is a long-acting glucagon-like peptide 1 (GLP-1) receptor agonist. The molecule consists 
of 2 identical disulfide-linked chains, each containing a modified human GLP-1 analogue sequence 
covalently linked to a modified human immunoglobulin G4 (IgG4) heavy chain fragment (Fc) by a 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


30 

small peptide linker. The GLP-1 analog portion of dulaglutide is approximately 90 % homologous to 
native human GLP-1 (7-37). Native GLP-1 has a half-life of 1.5-2 minutes due to degradation by 
DPP-4 and renal clearance. In contrast to native GLP-1, dulaglutide is resistant to degradation by 
DPP-4, and has a large size that slows absorption and reduces renal clearance. These engineering 
features result in a soluble formulation and a prolonged half-life of 4.7 days, which makes it suitable 
for once-weekly subcutaneous administration. In addition, the dulaglutide molecule was engineered to 
prevent the Fcγ receptor-dependent immune response and to reduce its immunogenic potential. 
 
Dulaglutide exhibits several antihyperglycaemic actions of GLP-1. In the presence of elevated glucose 
concentrations, dulaglutide increases intracellular cyclic AMP (cAMP) in pancreatic beta cells leading 
to insulin release. Dulaglutide suppresses glucagon secretion which is known to be inappropriately 
elevated in patients with type 2 diabetes. Lower glucagon concentrations lead to decreased hepatic 
glucose output. Dulaglutide also slows gastric emptying. 
 
Pharmacodynamic effects 
Dulaglutide improves glycaemic control through the sustained effects of lowering fasting, pre-meal 
and postprandial glucose concentrations in patients with type 2 diabetes starting after the first 
dulaglutide administration and is sustained throughout the once weekly dosing interval. 
 
A pharmacodynamic study with dulaglutide demonstrated, in patients with type 2 diabetes, a 
restoration of first phase insulin secretion to a level that exceeded levels observed in healthy subjects 
on placebo, and improved second phase insulin secretion in response to an intravenous bolus of 
glucose. In the same study, a single 1.5 mg dose of dulaglutide appeared to increase maximal insulin 
secretion from the β-cells, and to enhance β-cell function in subjects with type 2 diabetes mellitus as 
compared with placebo. 
 
Consistent with the pharmacokinetic profile, dulaglutide has a pharmacodynamic profile suitable for 
once weekly administration (see section 5.2). 
 
Clinical efficacy and safety 
 
Glycaemic control 
The safety and efficacy of dulaglutide were evaluated in nine randomised, controlled, phase III trials 
involving 6,193 patients with type 2 diabetes. Of these, 1,206 were ≥ 65 years of which 119 were 
≥ 75 years. These studies included 3,808 dulaglutide treated patients, of whom 2,250 were treated with 
Trulicity 1.5 mg weekly and 1,558 were treated with Trulicity 0.75 mg weekly. In all studies, 
dulaglutide produced clinically significant improvements in glycaemic control as measured by 
glycosylated haemoglobin A1c (HbA1c).  
 
Monotherapy 
Dulaglutide was studied in a 52 week active controlled monotherapy study in comparison to 
metformin. Trulicity 1.5 mg and 0.75 mg were superior to metformin (1500-2000 mg/day) in the 
reduction in HbA1c and a significantly greater proportion of patients reached an HbA1c target of 
< 7.0 % and ≤ 6.5 % with Trulicity 1.5 mg and Trulicity 0.75 mg compared to metformin at 26 weeks.  
 



31 

Table 2: Results of a 52 week active controlled monotherapy study with two doses of dulaglutide in 
comparison to metformin 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in  
body 

weight 
 (%) (%) <7.0% (%) ≤6.5% (%) (mmol/L) (kg) 

26 weeks 
Dulaglutide 1.5 mg 
once weekly (n=269) 7.63 -0.78

†† 61.5# 46.0## -1.61 -2.29 

Dulaglutide 0.75 mg 
once weekly (n=270) 7.58 -0.71

†† 62.6# 40.0# -1.46 -1.36# 

Metformin 
1500-2000 mg/day 
(n=268) 

7.60 -0.56 53.6 29.8 -1.34 -2.22 

52 weeks 
Dulaglutide 1.5 mg 
once weekly (n=269) 7.63 -0.70

†† 60.0# 42.3## -1.56# -1.93 

Dulaglutide 0.75 mg 
once weekly (n=270) 7.58 -0.55

† 53.2 34.7 -1.00 -1.09# 

Metformin 
1500-2000 mg/day 
(n=268) 

7.60 -0.51 48.3 28.3 -1.15 -2.20 

† multiplicity adjusted 1-sided p-value < 0.025, for noninferiority; †† multiplicity adjusted 1-sided 
p-value < 0.025, for superiority of dulaglutide to metformin, assessed  for HbA1c only 

# p < 0.05, ## p < 0.001 dulaglutide treatment group compared to metformin  
 
The rate of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and 
metformin were 0.62, 0.15, and 0.09 episodes/patient/year, respectively. No cases of severe 
hypoglycaemia were observed. 
 
Combination therapy with metformin  
The safety and efficacy of dulaglutide was investigated in a placebo and active controlled (sitagliptin 
100 mg daily) study of 104 weeks duration, all in combination with metformin. Treatment with 
Trulicity 1.5 mg and 0.75 mg resulted in a superior reduction in HbA1c compared to sitagliptin at 
52 weeks, accompanied by a significantly greater proportion of patients achieving HbA1c targets of 
< 7.0 % and ≤ 6.5 %. These effects were sustained to the end of the study (104 weeks).  
 



32 

Table 3: Results of a 104 week placebo and active controlled study with two doses of dulaglutide in 
comparison to sitagliptin 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in 
body 

weight 
 (%) (%) <7.0 %(%) ≤6.5 %(%) (mmol/L) (kg) 

26 weeks 
Dulaglutide 1.5 mg 
once weekly (n=304) 8.12 -1.22

‡‡,## 60.9**,## 46.7**,## -2.38**,## -3.18**,## 

Dulaglutide 0.75 mg 
once weekly (n=302) 8.19 -1.01

‡‡,## 55.2**,## 31.0**,## -1.97**,## -2.63**,## 

Placebo (n= 177) 8.10 0.03 21.0 12.5 -0.49 -1.47 
Sitagliptin 
100 mg once daily 
(n=315) 

8.09 -0.61 37.8 21.8 -0.97 -1.46 

52 weeks 
Dulaglutide 1.5 mg 
once weekly (n=304) 8.12 -1.10

†† 57.6## 41.7## -2.38## -3.03## 

Dulaglutide 0.75 mg 
once weekly (n=302) 8.19 -0.87

†† 48.8## 29.0## -1.63## -2.60## 

Sitagliptin 100 mg 
once daily (n=315) 8.09 -0.39 33.0 19.2 -0.90 -1.53 

104 weeks 
Dulaglutide 1.5 mg 
once weekly (n=304) 8.12 -0.99

†† 54.3## 39.1## -1.99## -2.88## 

Dulaglutide 0.75 mg 
once weekly (n=302) 8.19 -0.71

†† 44.8## 24.2## -1.39## -2.39 

Sitagliptin 100 mg 
once daily (n=315) 8.09 -0.32 31.1 14.1 -0.47 -1.75 

†† multiplicity adjusted 1-sided p-value < 0.025, for superiority of dulaglutide compared to sitagliptin, 
assessed only for HbA1c at 52 and 104 weeks 

‡‡ multiplicity adjusted 1-sided p-value < 0.001 for superiority of dulaglutide compared to placebo, 
assessed for HbA1c only 

** p < 0.001 dulaglutide treatment group compared to placebo 
## p < 0.001 dulaglutide treatment group compared to sitagliptin 
 
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and 
sitagliptin were 0.19, 0.18, and 0.17 episodes/patient/year, respectively. No cases of severe 
hypoglycaemia with dulaglutide were observed. 
 
The safety and efficacy of dulaglutide was also investigated in an active controlled study (liraglutide 
1.8 mg daily) of 26 weeks duration, both in combination with metformin. Treatment with Trulicity 
1.5 mg resulted in similar lowering of HbA1c and patients achieving HbA1c targets of < 7.0 % and 
≤ 6.5 % compared to liraglutide.  



33 

Table 4: Results of a 26 week active controlled study of one dose of dulaglutide in comparison to 
liraglutide 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in 
body 

weight 
 (%) (%) <7.0 %(%) ≤6.5 %(%) (mmol/L) (kg) 

26 weeks 
Dulaglutide 1.5 mg 
once weekly (n=299) 8.06 

-1.42‡ 68.3 54.6 -1.93 -2.90# 

Liraglutide+ 1.8 mg 
daily (n=300) 8.05 

-1.36 67.9 50.9 -1.90 -3.61 
‡ 1-sided p-value p < 0.001, for noninferiority of dulaglutide compared to liraglutide, assessed only 

for HbA1c. 
# p < 0.05 dulaglutide treatment group compared to liraglutide. 
+ Patients randomised to liraglutide were initiated at a dose of 0.6 mg/day. After Week 1, patients 

were up-titrated to 1.2 mg/day and then at Week 2 to 1.8 mg/day. 
 
The rate of documented symptomatic hypoglycaemia with Trulicity 1.5 mg was 
0.12 episodes/patient/year and with liraglutide was 0.29 episodes/patient/year. No cases of severe 
hypoglycaemia were observed 
 
Combination therapy with metformin and sulphonylurea 
In an active controlled study of 78 weeks duration, dulaglutide was compared to insulin glargine, both 
on a background of metformin and a sulphonylurea. At 52 weeks, Trulicity 1.5 mg demonstrated 
superior lowering in HbA1c to insulin glargine which was maintained at 78 weeks; whereas lowering 
in HbA1c with Trulicity 0.75 mg was non-inferior to insulin glargine. With Trulicity 1.5 mg a 
significantly higher percentage of patients reached a target HbA1c of < 7.0 % or ≤ 6.5 % at 52 and 
78 weeks compared to insulin glargine.  
 
Table 5: Results of a 78 week active controlled study with two doses of dulaglutide in comparison to 
insulin glargine 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in 
body 

weight 
 (%) (%) <7.0% (%) ≤6.5% (%) (mmol/L) (kg) 

52 weeks 
Dulaglutide 1.5 mg 
once weekly (n=273) 8.18 -1.08

†† 53.2## 27.0## -1.50 -1.87## 

Dulaglutide 0.75 mg 
once weekly (n=272) 8.13 -0.76

† 37.1 22.5# -0.87## -1.33## 

Insulin glargine+ 
once daily (n=262) 8.10 -0.63 30.9 13.5 -1.76 1.44 

78 weeks 
Dulaglutide 1.5 mg 
once weekly (n=273) 8.18 -0.90

†† 49.0## 28.1## -1.10# -1.96## 

Dulaglutide 0.75 mg 
once weekly (n=272) 8.13 -0.62† 34.1 22.1 -0.58

## -1.54## 

Insulin glargine+ 
once daily (n=262) 8.10 -0.59 30.5 16.6 -1.58 1.28 

† multiplicity adjusted 1-sided p-value < 0.025, for noninferiority; †† multiplicity adjusted 1-sided 
p-value < 0.025, for superiority of dulaglutide to insulin glargine, assessed for HbA1c only 

# p < 0.05, ## p < 0.001 dulaglutide treatment group compared to insulin glargine  
+  Insulin glargine doses were adjusted utilising an algorithm with a fasting plasma glucose target of 

< 5.6 mmol/L 
 
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and insulin 
glargine were 1.67, 1.67, and 3.02 episodes/patient/year, respectively. Two cases of severe 



34 

hypoglycaemia were observed with Trulicity 1.5mg and two cases of severe hypoglycaemia were 
observed with insulin glargine. 
 
Combination therapy with sulphonylurea 
The safety and efficacy of dulaglutide as add-on to a sulphonylurea was investigated in a placebo 
controlled study of 24 weeks duration. Treatment with Trulicity 1.5mg in combination with 
glimepiride resulted in a statistically significant reduction in HbA1c compared to placebo with 
glimepiride at 24 weeks.   With Trulicity 1.5 mg, a significantly higher percentage of patients reached 
a target HbA1c of < 7.0 % and ≤ 6.5 % at 24 weeks compared to placebo.  
 
Table 6: Results of a 24 week placebo controlled study of dulaglutide as add-on to glimepiride 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in 
body 

weight 
 (%) (%) <7.0% (%) ≤6.5% (%) (mmol/L) (kg) 

24 weeks 
Dulaglutide 1.5 mg 
once weekly (n=239) 8.39 -1.38

‡‡ 55.3‡‡ 40.0** -1.70‡‡ -0.91 

Placebo (n=60) 8.39 -0.11 18.9 9.4 0.16 -0.24 
‡‡  p < 0.001 for superiority of dulaglutide compared to placebo, with overall type I error controlled 
** p < 0.001 for dulaglutide treatment group compared to placebo  
 
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and placebo were 0.90 
and 0.04 episodes/patient/year, respectively. No cases of severe hypoglycaemia were observed for 
Trulicity or placebo. 
 
Combination therapy with SGLT2 inhibitor with or without metformin  
The safety and efficacy of dulaglutide as add-on to sodium-glucose co-transporter 2 inhibitor 
(SGLT2i) therapy (96% with and 4% without metformin) were investigated in a placebo controlled 
study of 24 weeks duration. Treatment with Trulicity 0.75 mg or Trulicity 1.5 mg in combination with 
SGLT2i therapy resulted in a statistically significant reduction in HbA1c compared to placebo with 
SGLT2i therapy at 24 weeks. With both Trulicity 0.75 mg and 1.5 mg, a significantly higher 
percentage of patients reached a target HbA1c of < 7.0% and ≤ 6.5% at 24 weeks compared to 
placebo.  
 
Table 7: Results of a 24 week placebo controlled study of dulaglutide as add-on to SGLT2i therapy 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in 
body 

weight 
 (%) (%) <7.0%^ (%) ≤6.5% (%) (mmol/L) (kg) 

24 weeks 
Dulaglutide 0.75 mg 
once weekly (n=141) 8.05 -1.19

‡‡ 58.8‡‡ 38.9** -1.44 -2.6 

Dulaglutide 1.5 mg 
once weekly (n=142) 8.04 -1.33

‡‡ 67.4‡‡ 50.8** -1.77 -3.1 

Placebo (n=140) 8.05 -0.51 31.2 14.6 -0.29 -2.3 
‡‡  p < 0.001 for superiority of dulaglutide compared to placebo, with overall type I error controlled 
** p < 0.001 for dulaglutide treatment group compared to placebo  
^ Patients who withdrew from randomized treatment before 24 weeks were considered as not meeting 
the target 
 
The rates of documented symptomatic hypoglycaemia with Trulicity 0.75 mg, Trulicity 1.5 mg, and 
placebo were 0.15, 0.16 and 0.12 episodes/patient/year, respectively. One patient reported severe 
hypoglycaemia with Trulicity 0.75 mg in combination with SGLT2i therapy and none with Trulicity 
1.5 mg or placebo. 



35 

 
Combination therapy with metformin and pioglitazone 
In a placebo and active (exenatide twice daily) controlled study, both in combination with metformin 
and pioglitazone, Trulicity 1.5 mg and 0.75 mg demonstrated superiority for HbA1c reduction in 
comparison to placebo and exenatide, accompanied by a significantly a greater percentage of patients 
achieving HbA1c targets of < 7.0 % or ≤ 6.5 % 
 
Table 8: Results of a 52 week active controlled study with two doses of dulaglutide in comparison to 
exenatide 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in 
body 

weight 
 (%) (%) <7.0% (%) ≤6.5% (%) (mmol/L) (kg) 

26 weeks 
Dulaglutide 1.5 mg 
once weekly (n=279) 8.10 -1.51‡‡,

†† 78.2**,## 62.7**,## -2.36**,## -1.30** 

Dulaglutide 0.75 mg 
once weekly (n=280) 8.05 -1.30‡‡/

†† 65.8**/## 53.2**/## -1.90**/## 0.20 */## 

Placebo (n=141)  8.06 -0.46  42.9 24.4 -0.26 1.24 
Exenatide+ 
10 mcg twice daily 
(n=276) 

8.07 -0.99 52.3 38.0 -1.35 -1.07 

52 weeks 
Dulaglutide 1.5 mg 
once weekly (n=279) 8.10 -1.36

†† 70.8## 57.2## -2.04## -1.10 

Dulaglutide 0.75 mg 
once weekly (n=280) 8.05 -1.07

†† 59.1# 48.3## -1.58# 0.44# 

Exenatide+ 
10 mcg twice daily 
(n=276) 

8.07 -0.80 49.2 34.6 -1.03 -0.80 

†† multiplicity adjusted 1-sided p-value < 0.025, for superiority of dulaglutide to exenatide, assessed 
for HbA1c only 
‡‡ multiplicity adjusted 1-sided p-value < 0.001 for superiority of dulaglutide compared to placebo, 
assessed for HbA1c only 
* p < 0.05, **p < 0.001 dulaglutide treatment group compared to placebo 
# p < 0.05, ##p < 0.001 dulaglutide treatment group compared to exenatide 
+ Exenatide dose was 5 mcg twice daily for first 4 weeks and 10 mcg twice daily thereafter 
 
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and 
exenatide twice daily were 0.19, 0.14, and 0.75 episodes/patient/year, respectively. No cases of severe 
hypoglycaemia were observed for dulaglutide and two cases of severe hypoglycaemia were observed 
with exenatide twice daily. 
 
Combination therapy with titrated basal insulin, with or without metformin 
In a 28 week placebo controlled study, Trulicity1.5 mg was compared to placebo as add-on to titrated 
basal insulin glargine (88% with and 12% without metformin) to evaluate the effect on glycaemic 
control and safety. To optimise the insulin glargine dose, both groups were titrated to a target fasting 
serum glucose of <5.6 mmol/L. The mean baseline dose of insulin glargine was 37 units/day for 
patients receiving placebo and 41 units/day for patients receiving Trulicity 1.5mg.  The initial insulin 
glargine doses in patients with HbA1c <8.0% were reduced by 20%. At the end of the 28 week 
treatment period the dose was 65 units/day and 51 units/day, for patients receiving placebo and 
Trulicity 1.5 mg, respectively. At 28 weeks, treatment with once weekly Trulicity 1.5 mg resulted in a 
statistically significant reduction in HbA1c compared to placebo and a significantly greater percentage 
of patients achieving HbA1c targets of < 7.0 % and ≤ 6.5 % (Table 9). 
  



36 

Table 9: Results of a 28 week study of dulaglutide compared to placebo as add-on to titrated insulin 
glargine 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in 
body 

weight 
 (%) (%) <7.0% (%) ≤6.5% (%) (mmol/L) (kg) 

28 weeks 
Dulaglutide 1.5 mg 
once weekly and 
insulin glargine 
(n=150) 

8.41 -1.44‡‡ 66.7‡‡ 50.0** -2.48‡‡ -1.91‡‡ 

Placebo once weekly 
and insulin glargine 
(n=150) 

8.32 -0.67 33.3 16.7 -1.55 0.50 

‡‡  p < 0.001 for superiority of dulaglutide compared to placebo, overall type I error controlled 
** p < 0.001 dulaglutide treatment group compared to placebo 
 
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and insulin glargine were 
3.38 episodes/patient/year compared to placebo and insulin glargine 4.38 episodes/patient/year.  One 
patient reported severe hypoglycaemia with Trulicity 1.5 mg in combination with insulin glargine and 
none with placebo. 
 
Combination therapy with prandial insulin with or without metformin 
In this study, patients on 1 or 2 insulin injections per day prior to study entry, discontinued their 
prestudy insulin regimen and were randomised to dulaglutide once weekly or insulin glargine once 
daily, both in combination with prandial insulin lispro three times daily, with or without metformin. At 
26 weeks, both Trulicity 1.5 mg and 0.75mg were superior to insulin glargine in lowering of HbA1c 
and this effect was sustained at 52 weeks. A greater percentage of patients achieved HbA1c targets of 
< 7.0 % or ≤ 6.5 % at 26 weeks and < 7.0 % at 52 weeks than with insulin glargine.  
 
Table 10: Results of a 52 week active controlled study with two doses of dulaglutide in comparison to 
insulin glargine 
 

 Baseline 
HbA1c 

Mean 
change in 

HbA1c 

Patients at target 
HbA1c 

Change in 
FBG 

Change in 
body 

weight 
 (%) (%) <7.0% (%) ≤6.5% (%) (mmol/L) (kg) 

26 weeks 
Dulaglutide 1.5 mg 
once weekly (n=295) 8.46 -1.64

†† 67.6# 48.0# -0.27## -0.87## 

Dulaglutide 0.75 mg 
once weekly (n=293) 8.40 -1.59

†† 69.0# 43.0 0.22## 0.18## 

Insulin glargine+ 
once daily (n=296) 8.53 -1.41 56.8 37.5 -1.58 2.33 

52 weeks 
Dulaglutide 1.5 mg 
once weekly (n=295) 8.46 -1.48

†† 58.5# 36.7 0.08## -0.35## 

Dulaglutide 0.75 mg 
once weekly (n=293) 8.40 -1.42

†† 56.3 34.7 0.41## 0.86## 

Insulin glargine+ 
once daily (n=296) 8.53 -1.23 49.3 30.4 -1.01 2.89 

†† multiplicity adjusted 1-sided p-value < 0.025, for superiority of dulaglutide to insulin glargine, 
assessed for HbA1c only 

# p < 0.05, ## p < 0.001 dulaglutide treatment group compared to insulin glargine 
+ Insulin glargine doses were adjusted utilizing an algorithm with a fasting plasma glucose target of 

< 5.6 mmol/L 
 



37 

The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and 0.75 mg, and insulin 
glargine were 31.06, 35.66, and 40.95 episodes/patient/year, respectively. Ten patients reported severe 
hypoglycaemia with Trulicity 1.5 mg, seven with Trulicity 0.75 mg, and fifteen with insulin glargine. 
 
Fasting blood glucose 
Treatment with dulaglutide resulted in significant reductions from baseline in fasting blood glucose. 
The majority of the effect on fasting blood glucose concentrations occurred by 2 weeks. The 
improvement in fasting glucose was sustained through the longest study duration of 104 weeks. 
 
Postprandial glucose 
Treatment with dulaglutide resulted in significant reductions in mean post prandial glucose from 
baseline (changes from baseline to primary time point -1.95 mmol/L to -4.23 mmol/L). 
 
Beta-cell function 
Clinical studies with dulaglutide have indicated enhanced beta-cell function as measured by 
homeostasis model assessment (HOMA2-%B). The durability of effect on beta-cell function was 
maintained through the longest study duration of 104 weeks. 
 
Body weight 
Trulicity 1.5 mg was associated with sustained weight reduction over the duration of studies (from 
baseline to final time point -0.35 kg to -2.90 kg). Changes in body weight with Trulicity 0.75 mg 
ranged from 0.86 kg to -2.63 kg. Reduction in body weight was observed in patients treated with 
dulaglutide irrespective of nausea, though the reduction was numerically larger in the group with 
nausea. 
 
Patient reported outcomes 
Dulaglutide significantly improved total treatment satisfaction compared to exenatide twice daily. In 
addition, there was significantly lower perceived frequency of hyperglycaemia and hypoglycaemia 
compared to exenatide twice daily. 
 
Blood pressure 
The effect of dulaglutide on blood pressure as assessed by Ambulatory Blood Pressure Monitoring 
was evaluated in a study of 755 patients with type 2 diabetes. Treatment with dulaglutide provided 
reductions in systolic blood pressure (SBP) (-2.8 mmHg difference compared to placebo) at 16 weeks. 
There was no difference in diastolic blood pressure (DBP). Similar results for SBP and DBP were 
demonstrated at the final 26 week time point of the study. 
 
Cardiovascular Evaluation 
 
Meta-analysis of phase II and III studies 
In a meta-analysis of phase II and III registration studies, a total of 51 patients (dulaglutide: 26 [N = 
3,885]; all comparators: 25 [N = 2,125]) experienced at least one cardiovascular (CV) event (death due 
to CV causes, nonfatal MI, nonfatal stroke, or hospitalisation for unstable angina). The results showed 
that there was no increase in CV risk with dulaglutide compared with control therapies (HR: 0.57; CI: 
[0.30, 1.10]). 
 
Cardiovascular outcome study 
The Trulicity long-term cardiovascular outcome study was a placebo-controlled, double-blind clinical 
trial. Type 2 diabetes patients were randomly allocated to either Trulicity 1.5 mg (4,949) or placebo 
(4,952) both in addition to standards of care for type 2 diabetes (the 0.75 mg dose was not 
administered in this study). The median study follow-up time was 5.4 years.  
 
The mean age was 66.2 years, the mean BMI was 32.3 kg/m², and 46.3 % of patients were female. 
There were 3,114 (31.5 %) patients with established CV disease. The median baseline HbA1c was 
7.2 %. The Trulicity treatment arm included patients ≥ 65 years (n = 2,619) and ≥ 75 years (n = 484), 
and patients with mild (n = 2,435), moderate (n = 1,031) or severe (n = 50) renal impairment.  
 



38 

The primary endpoint was the time from randomisation to first occurrence of any major adverse 
cardiovascular events (MACE): CV death, non-fatal myocardial infarction, or non-fatal stroke. 
Trulicity was superior in preventing MACE compared to placebo (Figure 1). Each MACE component 
contributed to the reduction of MACE, as shown in Figure 2. 
 
 

 
 
Figure 1. Kaplan-Meier plot of time to first occurrence of the composite outcome: CV death, non-fatal 
myocardial infarction or non-fatal stroke, in the dulaglutide long-term cardiovascular outcome study 
 



39 

 

 
 
Figure 2: Forest plot of analyses of individual cardiovascular event types, all cause death, and 
consistency of effect across subgroups for the primary endpoint  
 
A significant and sustained reduction in HbA1c levels from baseline to month 60 was observed with 
Trulicity vs placebo, in addition to standard of care (-0.29 % vs 0.22 %; estimated treatment 
difference -0.51 % [-0.57; -0.45]; p < 0.001). There were significantly fewer patients in the Trulicity 
group who received an additional glycaemic intervention compared to placebo (Trulicity: 2,086 
[42.2 %]; placebo: 2,825 [57.0 %]; p < 0.001). 
 
Special populations 
 
Use in patients with renal impairment 
In a 52 week study, Trulicity 1.5 mg and 0.75 mg were compared to titrated insulin glargine as add-on 
to prandial insulin lispro to evaluate the effect on glycaemic control and safety of patients with 
moderate to severe chronic kidney disease (eGFR [by CKD-EPI] <60 and ≥15 mL/min/1.73 m2). 



40 

Patients discontinued their prestudy insulin regimen at randomisation.  At baseline, overall mean 
eGFR was 38 mL/min/1.73 m2, 30% of patients had eGFR < 30 mL/min/1.73 m2. 
 
At 26 weeks, both Trulicity 1.5 mg and 0.75 mg were non-inferior to insulin glargine in lowering of 
HbA1c and this effect was sustained at 52 weeks. A similar percentage of patients achieved HbA1c 
targets of < 8.0 % at 26 and 52 weeks with both dulaglutide doses as well as insulin glargine. 
 
Table 11: Results of a 52 week active controlled study with two doses of dulaglutide in comparison to 
insulin glargine (in patients with moderate to severe chronic kidney disease) 
 

 Baseline 
HbA1c 

Mean change 
in HbA1c 

Patients at 
target 
HbA1c 

Change in 
FBG 

 

Change in 
body weight 

 

 (%) (%) <8.0% (%) (mmol/L) (kg) 
26 weeks 
Dulaglutide 1.5 mg 
once weekly (n=192) 8.60 -1.19

† 78.3 1.28## -2.81## 

Dulaglutide 0.75 mg 
once weekly (n=190) 8.58 -1.12

† 72.6 0.98## -2.02## 

Insulin glargine+ 
once daily (n=194) 8.56 -1.13 75.3 -1.06 1.11 

52 weeks 
Dulaglutide 1.5 mg 
once weekly (n=192) 8.60 -1.10

† 69.1 1.57## -2.66## 

Dulaglutide 0.75 mg 
once weekly (n=190) 8.58 -1.10

† 69.5 1.15## -1.71## 

Insulin glargine+ 
once daily (n=194) 8.56 -1.00 70.3 -0.35 1.57 

† 1-sided p-value < 0.025, for non-inferiority of dulaglutide to insulin glargine 
##  p < 0.001 dulaglutide treatment group compared to insulin glargine 
+ Insulin glargine doses were adjusted utilizing an algorithm with a fasting plasma glucose target of 

≤ 8.3 mmol/L 
 
The rates of documented symptomatic hypoglycaemia with Trulicity 1.5 mg and Trulicity 0.75 mg, 
and insulin glargine were 4.44, 4.34, and 9.62 episodes/patient/year, respectively. No patients reported 
cases of severe hypoglycaemia with Trulicity 1.5 mg, six with Trulicity 0.75 mg, and seventeen with 
insulin glargine. The safety profile of Trulicity in patients with renal impairment was similar to that 
observed in other studies with Trulicity. 
 
Paediatric population 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Trulicity in one or more subsets of the paediatric population for the treatment of type 2 diabetes 
mellitus (see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
Following subcutaneous administration to patients with type 2 diabetes, dulaglutide reaches peak 
plasma concentrations in 48 hours. The mean peak (Cmax) and total (AUC) exposures were 
approximately 114 ng/ml and 14,000 ngh/ml, respectively, after multiple subcutaneous 1.5 mg doses 
of dulaglutide in patients with type 2 diabetes. Steady-state plasma concentrations were achieved 
between 2 to 4 weeks of once-weekly administration of dulaglutide (1.5 mg). Exposures after 
subcutaneous administration of single dulaglutide (1.5 mg) doses in the abdomen, thigh, or upper arm 
were comparable. The mean absolute bioavailability of dulaglutide following single-dose 
subcutaneous administration of single 1.5 mg and 0.75 mg doses was 47 % and 65%, respectively. 
 



41 

Distribution 
The mean volume of distribution after subcutaneous administration of dulaglutide 0.75 mg and 1.5 mg 
at steady state in patients with type 2 diabetes mellitus were approximately 19.2 L and 17.4 L. 
 
Biotransformation  
Dulaglutide is presumed to be degraded into its component amino acids by general protein catabolism 
pathways. 
 
Elimination 
The mean apparent clearance of dulaglutide 0.75 mg and 1.5 mg at steady state was 0.111  L/h and 
0.107 L/h with an elimination half-life of 4.5 and 4.7 days, respectively. 
 
Special populations 
 
Elderly 
Age had no clinically relevant effect on the pharmacokinetic and pharmacodynamic properties of 
dulaglutide. 
 
Gender and race 
Gender and race had no clinically meaningful effect on the pharmacokinetics of dulaglutide. 
 
Body weight or body mass index 
Pharmacokinetic analyses have demonstrated a statistically significant inverse relationship between 
body weight or body mass index (BMI) and dulaglutide exposure, although there was no clinically 
relevant impact of weight or BMI on glycaemic control. 
 
Renal impairment 
The pharmacokinetics of dulaglutide were evaluated in a clinical pharmacology study and were 
generally similar between healthy subjects and patients with mild to severe renal impairment 
(CrCl < 30 ml/min), including end stage renal disease (requiring dialysis). Additionally, in a 52-week 
clinical study in patients with type 2 diabetes and moderate to severe renal impairment (eGFR [by 
CKD-EPI] <60 and ≥15 mL/min/1.73 m2), the pharmacokinetic profile of Trulicity 0.75 mg and 1.5 
mg once weekly was similar to that demonstrated in previous clinical studies. This clinical study did 
not include patients with end stage renal disease. 
 
Hepatic impairment 
The pharmacokinetics of dulaglutide were evaluated in a clinical pharmacology study, where subjects 
with hepatic impairment had statistically significant decreases in dulaglutide exposure of up to 30 % to 
33 % for mean Cmax and AUC, respectively, compared to healthy controls. There was a general 
increase in tmax of dulaglutide with increased hepatic impairment. However, no trend in dulaglutide 
exposure was observed relative to the degree of hepatic impairment. These effects were not considered 
to be clinically relevant. 
 
Paediatric population 
Studies characterising the pharmacokinetics of dulaglutide in paediatric patients have not been 
performed. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazards for humans based on conventional studies of safety 
pharmacology or repeat-dose toxicity. 
 
In a 6-month carcinogenicity study in transgenic mice, there was no tumorigenic response. In a 2-year 
carcinogenicity study in rats, at ≥ 7 times the human clinical exposure following 1.5 mg dulaglutide 
per week, dulaglutide caused statistically significant, dose-related increases in the incidence of thyroid 
C-cell tumours (adenomas and carcinomas combined). The clinical relevance of these findings is 
currently unknown.  



42 

 
During the fertility studies, a reduction in the number of corpora lutea and prolonged oestrous cycle 
were observed at dose levels that were associated with decreased food intake and body weight gain in 
maternal animals; however, no effects on indices of fertility and conception or embryonic 
development were observed. In reproductive toxicology studies, skeletal effects and a reduction in 
foetal growth were observed in the rat and rabbit at exposures of dulaglutide 11- to 44-fold higher than 
those proposed clinically, but no foetal malformations were observed. Treatment of rats throughout 
pregnancy and lactation produced memory deficits in female offspring at exposures that were 16-fold 
higher than those proposed clinically. Dulaglutide dosing of male and female juvenile rats did not 
produce memory deficits at 91-fold the human exposure.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sodium citrate 
Citric acid, anhydrous  
Mannitol 
Polysorbate 80 
Water for injections 
 
6.2  Incompatibilities 
 
In the absence of compatibility studies this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
2 years 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2ºC – 8ºC). 
Do not freeze. 
Store in original package in order to protect from light. 
 
In-use: 
Trulicity may be stored unrefrigerated for up to 14 days at a temperature not above 30ºC. 
 
6.5 Nature and contents of container 
 
Glass syringe (type I). 
Each pre-filled syringe contains 0.5 ml of solution. 
Packs of 4 pre-filled syringes and multipack of 12 (3 packs of 4) pre-filled syringes. Not all pack sizes 
may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
Instructions for use 
The pre-filled syringe is for single-use only. 
The instructions for using the syringe, included with the package leaflet, must be followed carefully. 
Trulicity should not be used if particles appear or if the solution is cloudy and/or discoloured. 
Trulicity that has been frozen must not be used. 



43 

 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
 
8. MARKETING AUTHORISATION NUMBER 
 
EU/1/14/956/004 
EU/1/14/956/005 
EU/1/14/956/009 
EU/1/14/956/010 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 21 November 2014 
Date of latest renewal: 23 August 2019 
 
 
10. DATE OF REVISION OF THE TEXT  
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 
  

http://www.ema.europa.eu/


44 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE  
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE 

USE OF THE MEDICINAL PRODUCT 
 



45 

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturers of the biological active substance  
Eli Lilly Kinsale Limited 
Dunderrow 
Kinsale  
Co. Cork 
Ireland 
 
Name and address of the manufacturer(s) responsible for batch release 
Eli Lilly Italia S.p.A. 
Via Gramsci 731/733 
50019, Sesto Fiorentino 
Firenze (FI) 
Italy 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  
 

• Periodic Safety Update Reports (PSURs) 
 

The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 

 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the  agreed RMP presented in Module 1.8.2 of the marketing 
authorisation and any agreed  subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk profile or 
as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached.  

  



46 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



47 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



48 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON - PRE-FILLED PEN 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trulicity 0.75 mg solution for injection in pre-filled pen 
dulaglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled pen contains 0.75 mg of dulaglutide in 0.5 ml solution 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium citrate; citric acid, anhydrous; mannitol; polysorbate 80; water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
2 pre-filled pens of 0.5 ml solution 
4 pre-filled pens of 0.5 ml solution 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For single use only. 
Once weekly. 
 
Mark the day of the week you want to use your medicine to help you remember.  
  
 Mon Tues Wed Thu Fri Sat Sun 
 Week 1        
 Week 2        

 
 Mon Tues Wed Thu Fri Sat Sun 
 Week 1        
 Week 2        
 Week 3        
 Week 4        

 
Read the package leaflet before use. 
Subcutaneous use. 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 



49 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator.  
Do not freeze. 
Store in the original package in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/956/001 2 pre-filled pens 
EU/1/14/956/002 4 pre-filled pens 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 

 
www.trulicity.eu 
 
 
16. INFORMATION IN BRAILLE 
 
TRULICITY 0.75 mg 
 

http://www.trulicity.eu/


50 

 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 



51 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INTERMEDIATE CARTON (without Blue Box) component of a multipack - PRE-FILLED 
PEN 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trulicity 0.75 mg solution for injection in pre-filled pen 
dulaglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled pen contains 0.75 mg of dulaglutide in 0.5 ml solution 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium citrate; citric acid, anhydrous; mannitol; polysorbate 80; water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
Multi-pack: 4 pre-filled pens of 0.5 ml solution. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For single use only. 
Once weekly. 
 
Mark the day of the week you want to use your medicine to help you remember.  
  
 Mon Tues Wed Thu Fri Sat Sun 
 Week 1        
 Week 2        

 
 Mon Tues Wed Thu Fri Sat Sun 
 Week 1        
 Week 2        
 Week 3        
 Week 4        

 
Read the package leaflet before use. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 



52 

 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator.  
Do not freeze. 
Store in the original package in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/956/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 

 
www.trulicity.eu 
 
 
16. INFORMATION IN BRAILLE 
 
TRULICITY 0.75 mg 
 

http://www.trulicity.eu/


53 

 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
  



54 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (with Blue Box) – multipack - PRE-FILLED PEN 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trulicity 0.75 mg solution for injection in pre-filled pen 
dulaglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled pen contains 0.75 mg of dulaglutide in 0.5 ml solution 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium citrate; citric acid, anhydrous; mannitol; polysorbate 80; water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
Multi-pack: 12 (3 packs of 4) pre-filled pens of 0.5 ml solution. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For single use only. 
Read the package leaflet before use. 
Once weekly. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator.  
Do not freeze. 
Store in the original package in order to protect from light. 



55 

 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/956/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
TRULICITY 0.75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 

  



56 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON - PRE-FILLED PEN 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trulicity 1.5 mg solution for injection in pre-filled pen 
dulaglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled pen contains 1.5 mg of dulaglutide in 0.5 ml solution 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium citrate; citric acid, anhydrous; mannitol; polysorbate 80; water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
2 pre-filled pens of 0.5ml solution 
4 pre-filled pens of 0.5ml solution 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For single use only. 
Once weekly. 
 
Mark the day of the week you want to use your medicine to help you remember.  
  
 Mon Tues Wed Thu Fri Sat Sun 
 Week 1        
 Week 2        

 
 Mon Tues Wed Thu Fri Sat Sun 
 Week 1        
 Week 2        
 Week 3        
 Week 4        

 
Read the package leaflet before use. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 



57 

 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator.  
Do not freeze. 
Store in original package in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/956/006 2 pre-filled pens 
EU/1/14/956/007 4 pre-filled pens 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 

 
www.trulicity.eu 
 
 
16. INFORMATION IN BRAILLE 
 
TRULICITY 1.5 mg 

http://www.trulicity.eu/


58 

 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 



59 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INTERMEDIATE CARTON (without Blue Box) component of a multipack - PRE-FILLED 
PEN 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trulicity 1.5 mg solution for injection in pre-filled pen 
dulaglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled pen contains 1.5 mg of dulaglutide in 0.5 ml solution 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium citrate; citric acid, anhydrous; mannitol; polysorbate 80; water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
Multi-pack: 4 pre-filled pens of 0.5 ml solution. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For single use only. 
Once weekly. 
 
Mark the day of the week you want to use your medicine to help you remember.  
  
 Mon Tues Wed Thu Fri Sat Sun 
 Week 1        
 Week 2        

 
 Mon Tues Wed Thu Fri Sat Sun 
 Week 1        
 Week 2        
 Week 3        
 Week 4        

 
Read the package leaflet before use. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 



60 

 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator.  
Do not freeze. 
Store in the original package in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/956/008 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 

 
www.trulicity.eu 
 
 
16. INFORMATION IN BRAILLE 
 
TRULICITY 1.5 mg 

http://www.trulicity.eu/


61 

 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



62 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (with Blue Box) multipack - PRE-FILLED PEN 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trulicity 1.5 mg solution for injection in pre-filled pen 
dulaglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled pen contains 1.5 mg of dulaglutide in 0.5 ml solution 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium citrate; citric acid, anhydrous; mannitol; polysorbate 80; water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection  
Multi-pack: 12 (3 packs of 4) pre-filled pens of 0.5 ml solution. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For single use only. 
Read the package leaflet before use. 
Once weekly. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator.  
Do not freeze. 
Store in the original package in order to protect from light. 



63 

 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/956/008 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
TRULICITY 1.5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 



64 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON - PRE-FILLED SYRINGE 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trulicity 0.75 mg solution for injection in pre-filled syringe 
dulaglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 0.75 mg of dulaglutide in 0.5 ml solution 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium citrate; citric acid, anhydrous; mannitol; polysorbate 80; water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
4 pre-filled syringes of 0.5 ml solution 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For single use only. 
Once weekly. 
 
Mark the day of the week you want to use your medicine to help you remember. 
  
 Mon Tues Wed Thu Fri Sat Sun 
 Week 1        
 Week 2        
 Week 3        
 Week 4        

 
Read the package leaflet before use. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
If seal is broken before first use, contact pharmacist. 
 



65 

 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original package in order to protect from light.  
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/956/004 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
TRULICITY 0.75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 



66 

NN: {number} 
 
  



67 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INTERMEDIATE CARTON (without Blue Box) component of a multipack - PRE-FILLED 
SYRINGE 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trulicity 0.75 mg solution for injection in pre-filled syringe 
dulaglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 0.75 mg of dulaglutide in 0.5 ml solution 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium citrate; citric acid, anhydrous; mannitol; polysorbate 80; water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
Multi-pack: 4 pre-filled syringes of 0.5 ml solution. Component of a multipack, can’t be sold 
separately 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For single use only. 
Once weekly. 
 
Mark the day of the week you want to use your medicine to help you remember. 
  
 Mon Tues Wed Thu Fri Sat Sun 
 Week 1        
 Week 2        
 Week 3        
 Week 4        

 
Read the package leaflet before use. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 



68 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
If seal is broken before first use, contact pharmacist. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original package in order to protect from light.  
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/956/005 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
TRULICITY 0.75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 



69 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (with Blue Box) multipack - PRE-FILLED SYRINGE 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trulicity 0.75 mg solution for injection in pre-filled syringe 
dulaglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 0.75 mg of dulaglutide in 0.5 ml solution 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium citrate; citric acid, anhydrous; mannitol; polysorbate 80; water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
Multi-pack: 12 (3 packs of 4) pre-filled syringes of 0.5 ml solution. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For single use only. 
Read the package leaflet before use. 
Once weekly.  
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
If seal is broken before first use, contact pharmacist. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



70 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original package in order to protect from light.  
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/956/005 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
TRULICITY 0.75 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
  



71 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON - PRE-FILLED SYRINGE 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trulicity 1.5 mg solution for injection in pre-filled syringe 
dulaglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 1.5 mg of dulaglutide in 0.5 ml solution 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium citrate; citric acid, anhydrous; mannitol; polysorbate 80; water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
4 pre-filled syringes of 0.5 ml solution 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For single use only. 
Once weekly. 
 
Mark the day of the week you want to use your medicine to help you remember. 
  
 Mon Tues Wed Thu Fri Sat Sun 
 Week 1        
 Week 2        
 Week 3        
 Week 4        

 
Read the package leaflet before use. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
If seal is broken before first use, contact pharmacist. 
 



72 

 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original package in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/956/009 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
TRULICITY 1.5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 



73 

NN: {number} 
 



74 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INTERMEDIATE CARTON (without Blue Box) component of a multipack - PRE-FILLED 
SYRINGE 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trulicity 1.5 mg solution for injection in pre-filled syringe 
dulaglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 1.5 mg of dulaglutide in 0.5 ml solution 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium citrate; citric acid, anhydrous; mannitol; polysorbate 80; water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
Multi-pack: 4 pre-filled syringes of 0.5 ml solution. Component of a multipack, can’t be sold 
separately 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For single use only. 
Once weekly. 
 
Mark the day of the week you want to use your medicine to help you remember. 
  
 Mon Tues Wed Thu Fri Sat Sun 
 Week 1        
 Week 2        
 Week 3        
 Week 4        

 
Read the package leaflet before use. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 



75 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
If seal is broken before first use, contact pharmacist. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original package in order to protect from light.  
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/956/010 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
TRULICITY 1.5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 



76 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (with Blue Box) multipack - PRE-FILLED SYRINGE 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Trulicity 1.5 mg solution for injection in pre-filled syringe 
dulaglutide 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each pre-filled syringe contains 1.5 mg of dulaglutide in 0.5 ml solution 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Sodium citrate; citric acid, anhydrous; mannitol; polysorbate 80; water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
Multi-pack: 12 (3 packs of 4) pre-filled syringes of 0.5 ml solution. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For single use only. 
Read the package leaflet before use. 
Once weekly.  
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
If seal is broken before first use, contact pharmacist. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



77 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original package in order to protect from light.  
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V.  
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/956/010 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
TRULICITY 1.5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number} 
SN: {number} 
NN: {number} 
 
  



78 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Trulicity 0.75 mg solution for injection in pre-filled pen 
dulaglutide 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
Once weekly 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml 
 
 
6. OTHER 

 
  



79 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Trulicity 1.5 mg solution for injection in pre-filled pen 
dulaglutide 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
Once weekly 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml 
 
 
6. OTHER 

 
  



80 

 
 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Trulicity 0.75 mg injection 
dulaglutide 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
Once weekly 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml 
 
 
6. OTHER 

  



81 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Trulicity 1.5 mg injection 
dulaglutide 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
Once weekly 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
0.5 ml 
 
 
6. OTHER 
  



82 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



83 

Package leaflet: Information for the patient 
 

Trulicity 0.75 mg solution for injection in pre-filled pen 
Trulicity 1.5 mg solution for injection in pre-filled pen 

dulaglutide 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Trulicity is and what it is used for 
2. What you need to know before you use Trulicity 
3. How to use Trulicity 
4. Possible side effects 
5. How to store Trulicity 
6. Contents of the pack and other information 
 
 
1. What Trulicity is and what it is used for 
 
Trulicity contains an active substance called dulaglutide and is used to lower blood sugar (glucose) in 
adults with type 2 diabetes mellitus and can help prevent heart disease. 
 
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that  
your body produces does not work as well as it should.  
 
When this happens, sugar (glucose) builds up in the blood. 
 
Trulicity is used: 
- on its own if your blood sugar is not properly controlled by diet and exercise alone, and you 

can’t take metformin (another diabetes medicine). 
- or with other medicines for diabetes when they are not enough to control your blood sugar 

levels. These other medicines may be medicines taken by mouth and/or insulin given by 
injection. 

 
It is important to continue to follow the advice on diet and exercise given to you by your doctor, 
pharmacist or nurse. 
 
 
2. What you need to know before you use Trulicity 
 
Do not use Trulicity 

- if you are allergic to dulaglutide or any of the other ingredients of this medicine (listed in 
section 6).  

 
Warnings and precautions 
Talk to your doctor, pharmacist or nurse before using Trulicity if: 



84 

- you are on dialysis as this medicine is not recommended. 
- you have type 1 diabetes (the type when your body does not produce any insulin) as this 

medicine may not be right for you. 
- you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable 

to break down glucose because there is not enough insulin). The signs include rapid weight loss, 
feeling sick or being sick, a sweet smell to your breath, a sweet or metallic taste in your mouth, 
or a different odour to your urine or sweat. 

- you have severe problems with food digestion or food remaining in your stomach for longer 
than normal (including gastroparesis). 

- you have ever had pancreatitis (inflammation of the pancreas) which causes severe pain in the 
stomach and back which does not go away. 

- you are taking a sulphonylurea or insulin for your diabetes, as low blood sugar (hypoglycaemia) 
can occur. Your doctor may need to change your dose of these other medicines to reduce this 
risk. 

Trulicity is not an insulin and should therefore not be used as a substitute for insulin. 
 
When initiating treatment with Trulicity, you may in some cases experience loss of fluids/dehydration, 
e.g. in case of vomiting, nausea and/or diarrhoea which may lead to a decrease in kidney function. It is 
important to avoid dehydration by drinking plenty of fluids. Contact your doctor if you have any 
questions or concerns. 
 
Children and adolescents 
Trulicity is not recommended for children and adolescents under 18 years of age because it has not 
been studied in these patients. 
 
Other medicines and Trulicity 
Because Trulicity can slow stomach emptying which could affect other medicines, tell your doctor, 
pharmacist or nurse if you are using, have recently used or might use any other medicine. 
 
Especially tell your doctor: 

- if you are using other medicines that lower the amount of sugar in your blood, such as insulin or 
a medicine containing sulphonylurea. Your doctor may want to lower the dose of these other 
medicines to prevent you from getting low blood sugar levels (hypoglycaemia). Ask your 
doctor, pharmacist or nurse if you are not sure what your other medicines contain. 

- if you are using insulin, your doctor will tell you how to reduce the dose of insulin and will 
recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia 
(high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the 
body is unable to break down glucose because there is not enough insulin). 

 
Pregnancy and breast-feeding  
It is not known if dulaglutide could harm your unborn child. Women who could become pregnant 
should use contraception during treatment with dulagutide. Tell your doctor if you are pregnant, think 
you may be pregnant or are planning to have a baby, as Trulicity should not be used during pregnancy. 
Talk to your doctor about the best way to control your blood sugar while you are pregnant. 
 
Talk to your doctor if you would like to or are breast-feeding before taking this medicine. Do not use 
Trulicity if you are breast-feeding. It is not known if dulaglutide passes into human breast milk. 
 
Driving and using machines 
If you use Trulicity in combination with a sulphonylurea or insulin, low blood sugar (hypoglycaemia) 
may occur which may reduce your ability to concentrate. Please keep this in mind in all situations 
where you might put yourself and others at risk (e.g. driving a car or using machines). 
 
Trulicity contains sodium  
This medicine contains less than 1 mmol sodium (23 mg) per 0.75 mg or 1.5 mg, that is to say 
essentially ‘sodium-free’. 
 



85 

 
3. How to use Trulicity 
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure how to use this medicine. 
 
When used alone, the recommended dose is 0.75 mg once a week.  
When used with other medicines for diabetes, the recommended dose is 1.5 mg once a week. In certain 
situations, for example if you are 75 years or older, your doctor may recommend a starting dose of 
0.75 mg once a week. 
 
Each pen contains one weekly dose of Trulicity (0.75 mg or 1.5 mg). Each pen delivers only one dose.  
 
You can use your pen at any time of the day, with or without meals. You should use it on the same day 
each week if you can. To help you remember, you may wish to tick the day of the week when you 
inject your first dose on the box that your pen comes in, or on a calendar. 
 
Trulicity is injected under the skin (subcutaneous injection) of your stomach area (abdomen) or upper 
leg (thigh). If the injection is given by someone else, they may inject in your upper arm. 
 
If you want to do so, you can use the same area of your body each week. But be sure to choose a 
different injection site within that area. 
 
It is important that you test your blood glucose levels as instructed by your doctor, pharmacist or 
nurse, if you are taking Trulicity with a sulphonylurea or insulin. 
 
Read the “Instructions for Use” for the pen carefully before using Trulicity. 
 
If you use more Trulicity than you should 
If you use more Trulicity than you should talk to your doctor immediately. Too much Trulicity may 
make your blood sugar too low (hypoglycaemia) and can make you feel sick or be sick. 
 
If you forget to use Trulicity 
If you forget to inject a dose, and if there are at least 3 days before your next dose is due, then inject 
your dose as soon as possible. Inject your next dose on your regular scheduled day. 
 
If there are less then 3 days before your next dose is due, skip the dose and inject the next one on your 
regular scheduled day. 
 
Do not use a double dose to make up for a forgotten dose. 
 
You can also change the day of the week on which you inject Trulicity if necessary, as long as it has 
been at least 3 days since your last dose of Trulicity. 
 
If you stop using Trulicity 
Do not stop using Trulicity without talking with your doctor. If you stop using Trulicity, your blood 
sugar levels can increase. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 



86 

Severe side effects 
Rare: may affect up to 1 in 1,000 people 
- Severe allergic reactions (anaphylactic reactions, angioedema).  

 You should see a doctor immediately if you experience symptoms such as rashes, itching and 
rapid swelling of the tissues of the neck, face, mouth or throat, hives and difficulties breathing. 

 
- Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back 

which does not go away.  
You should see a doctor immediately if you experience such symptoms. 

 
Not known: the frequency cannot be estimated from the available data 

- Bowel obstruction - a severe form of constipation with additional symptoms such as stomach 
ache, bloating or vomiting.  

 You should see a doctor immediately if you experience such symptoms. 
 
Other side effects 
Very common: may affect more than 1 in 10 people 

- Nausea (feeling sick) 
- Vomiting (being sick) 
- Diarrhoea 
- Abdominal (stomach) pain. 

These side effects are usually not severe. They are most common when first starting dulaglutide but 
decrease over time in most patients. 
 

- Hypoglycaemia (low blood sugar) is very common when dulaglutide is used with medicines that 
contain metformin, a sulphonylurea and/or insulin. If you are taking a sulphonylurea or insulin, 
the dose may need to be lowered while you use dulaglutide. 

 
Common: may affect up to 1 in 10 people 

- Hypoglycaemia is common when dulaglutide is used alone, or with both metformin and 
pioglitazone together, or with a sodium-glucose co-transporter 2 inhibitor (SGLT2i) with or 
without metformin. 

- Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, feeling 
hungry, confusion, irritability, fast heartbeat and sweating. Your doctor should tell you how to 
treat low blood sugar. 

- Feeling less hungry (decreased appetite) 
- Indigestion 
- Constipation 
- Gas (flatulence) 
- Bloating of the stomach 
- Gastroesophageal reflux disease - a disease caused by stomach acid coming up into the tube 

from your stomach to your mouth 
- Burping 
- Feeling tired 
- Increased heart rate  
- Slowing of the electrical currents in the heart 

 
Uncommon: may affect up to 1 in 100 people 

- Injection site reactions (e.g. rash or redness) 
- Allergic reactions (hypersensitivity) (e.g. swelling, raised itchy skin rash (hives)) 
- Dehydration, often associated with nausea, vomiting and/or diarrhoea 
- Gallstones 
- Inflamed gallbladder 

 



87 

Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects, you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Trulicity 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the pen label and on the carton after  
EXP. The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2°C - 8°C). Do not freeze. 
 
Store in the original packaging in order to protect from light. 
 
Trulicity can be taken out of the fridge for up to 14 days at a temperature not above 30ºC. 
 
Do not use this medicine if you notice that the pen is damaged, or the medicine is cloudy, discoloured 
or has particles in it. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Trulicity contains 
The active substance is dulaglutide. 
- Trulicity 0.75 mg: Each pre-filled pen contains 0.75 mg of dulaglutide in 0.5 ml solution. 
- Trulicity 1.5 mg: Each pre-filled pen contains 1.5 mg of dulaglutide in 0.5 ml solution. 
  

The other ingredients are sodium citrate (see section 2 under ‘Trulicity contains sodium citrate’ for 
further information); citric acid, anhydrous; mannitol; polysorbate 80 and water for injections. 
 
What Trulicity looks like and contents of the pack 
Trulicity is a clear, colourless, solution for injection in a pre-filled pen. 
Each pre-filled pen contains 0.5 ml solution. 
The pre-filled pen is for single-use only. 
Pack sizes of 2, 4 or multipacks of 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be 
available in your country. 
 
Marketing Authorisation Holder  
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
Manufacturer 
Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino, Firenze (FI), Italy 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


88 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 
 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 60 00 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 

Eesti 
Tel: +372 6 817 280 
 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges.m.b.H.  
Tel: + 43-(0) 1 711 780 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

France 
Lilly France SAS 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0)1 580 00 10 

Ísland 
Icepharma hf. 
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā 
Tel: +371 67364000 
 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
This leaflet was last revised in Month YYYY 



89 

 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  
 
 
-------------------------------------------------------------------------------------------------------------------------- 

http://www.ema.europa.eu/


90 

Package leaflet: Information for the patient 
 

Trulicity 0.75 mg solution for injection in pre-filled syringe 
Trulicity 1.5 mg solution for injection in pre-filled syringe 

dulaglutide 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Trulicity is and what it is used for 
2. What you need to know before you use Trulicity 
3. How to use Trulicity 
4. Possible side effects 
5. How to store Trulicity 
6. Contents of the pack and other information 
 
 
1. What Trulicity is and what it is used for 
 
Trulicity contains an active substance called dulaglutide and is used to lower blood sugar (glucose) in 
adults with type 2 diabetes mellitus and can help prevent heart disease. 
 
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that  
your body produces does not work as well as it should.  
When this happens, sugar (glucose) builds up in the blood. 
 
Trulicity is used: 
- on its own if your blood sugar is not properly controlled by diet and exercise alone, and you 

can’t take metformin (another diabetes medicine). 
- or with other medicines for diabetes when they are not enough to control your blood sugar 

levels. These other medicines may be medicines taken by mouth and/or insulin given by 
injection. 

 
It is important to continue to follow the advice on diet and exercise given to you by your doctor, 
pharmacist or nurse. 
 
 
2. What you need to know before you use Trulicity 
 
Do not use Trulicity 

- if you are allergic to dulaglutide or any of the other ingredients of this medicine (listed in 
section 6).  

 
Warnings and precautions 
Talk to your doctor, pharmacist or nurse before using Trulicity if: 

- you are on dialysis as this medicine is not recommended. 
- you have type 1 diabetes (the type when your body does not produce any insulin) as this 

medicine may not be right for you. 



91 

- you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable 
to break down glucose because there is not enough insulin). The signs include rapid weight loss, 
feeling sick or being sick, a sweet smell to your breath, a sweet or metallic taste in your mouth, 
or a different odour to your urine or sweat. 

- you have severe problems with food digestion or food remaining in your stomach for longer 
than normal (including gastroparesis). 

- you have ever had pancreatitis (inflammation of the pancreas) which causes severe pain in the 
stomach and back which does not go away. 

- you are taking a sulphonylurea or insulin for your diabetes, as low blood sugar (hypoglycaemia) 
can occur. Your doctor may need to change your dose of these other medicines to reduce this 
risk. 

 
Trulicity is not an insulin and should therefore not be used as a substitute for insulin. 
 
When initiating treatment with Trulicity, you may in some cases experience loss of fluids/dehydration, 
e.g. in case of vomiting, nausea and/or diarrhoea which may lead to a decrease in kidney function. It is 
important to avoid dehydration by drinking plenty of fluids. Contact your doctor if you have any 
questions or concerns. 
 
Children and adolescents 
Trulicity is not recommended for children and adolescents under 18 years of age because it has not 
been studied in these patients. 
 
Other medicines and Trulicity 
Because Trulicity can slow stomach emptying which could affect other medicines, tell your doctor, 
pharmacist or nurse if you are using, have recently used or might use any other medicine. 
 
Especially tell your doctor: 

- if you are using other medicines that lower the amount of sugar in your blood, such as insulin or 
a medicine containing sulphonylurea. Your doctor may want to lower the dose of these other 
medicines to prevent you from getting low blood sugar levels (hypoglycaemia). Ask your 
doctor, pharmacist or nurse if you are not sure what your other medicines contain. 

- if you are using insulin, your doctor will tell you how to reduce the dose of insulin and will 
recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia 
(high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the 
body is unable to break down glucose because there is not enough insulin). 

 
Pregnancy and breast-feeding  
It is not known if dulaglutide could harm your unborn child. Women who could become pregnant 
should use contraception during treatment with dulagutide. Tell your doctor if you are pregnant, think 
you may be pregnant or are planning to have a baby, as Trulicity should not be used during pregnancy. 
Talk to your doctor about the best way to control your blood sugar while you are pregnant. 
 
Talk to your doctor if you would like to or are breast-feeding before taking this medicine. Do not use 
Trulicity if you are breast-feeding. It is not known if dulaglutide passes into human breast milk. 
 
Driving and using machines 
If you use Trulicity in combination with a sulphonylurea or insulin, low blood sugar (hypoglycaemia) 
may occur which may reduce your ability to concentrate. Please keep this in mind in all situations 
where you might put yourself and others at risk (e.g. driving a car or using machines). 
 
Trulicity contains sodium  
This medicine contains less than 1 mmol sodium (23 mg) per 0.75 mg or 1.5 mg, that is to say 
essentially ‘sodium-free’. 
 



92 

3. How to use Trulicity 
 
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure how to use this medicine. 
 
When used alone, the recommended dose is 0.75 mg once a week.  
 
When used with other medicines for diabetes, the recommended dose is 1.5 mg once a week. In certain 
situations, for example if you are 75 years or older, your doctor may recommend a starting dose of 
0.75 mg once a week. 
 
Each syringe contains one weekly dose of Trulicity (0.75 mg or 1.5 mg). Each syringe delivers only 
one dose. 
 
You can use your syringe at any time of the day, with or without meals. You should use it on the same 
day each week if you can. To help you remember, you may wish to tick the day of the week when you 
inject your first dose on the box that your syringe comes in, or on a calendar. 
 
Trulicity is injected under the skin (subcutaneous injection) of your stomach area (abdomen) or upper 
leg (thigh). If the injection is given by someone else, they may inject in your upper arm. 
 
If you want to do so, you can use the same area of your body each week. But be sure to choose a 
different injection site within that area. 
 
It is important that you test your blood glucose levels as instructed by your doctor, pharmacist or 
nurse, if you are taking Trulicity with a sulphonylurea or insulin. 
 
Read the “Instructions for Use” for the syringe carefully before using Trulicity. 
 
If you use more Trulicity than you should 
If you use more Trulicity than you should talk to your doctor immediately. Too much Trulicity may 
make your blood sugar too low (hypoglycaemia) and can make you feel sick or be sick. 
 
If you forget to use Trulicity 
If you forget to inject a dose, and if there are at least 3 days before your next dose is due, then inject 
your dose as soon as possible. Inject your next dose on your regular scheduled day. 
 
If there are less then 3 days before your next dose is due, skip the dose and inject the next one on your 
regular scheduled day. 
 
Do not use a double dose to make up for a forgotten dose. 
 
You can also change the day of the week on which you inject Trulicity if necessary, as long as it has 
been at least 3 days since your last dose of Trulicity. 
 
If you stop using Trulicity 
Do not stop using Trulicity without talking with your doctor. If you stop using Trulicity, your blood 
sugar levels can increase. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 



93 

Severe side effects 
Rare: may affect up to 1 in 1,000 people 

- Severe allergic reactions (anaphylactic reactions, angioedema).  
You should see a doctor immediately if you experience symptoms such as rashes, itching and 
rapid swelling of the tissues of the neck, face, mouth or throat, hives and difficulties breathing. 

 
-  Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back 

which does not go away.  
You should see a doctor immediately if you experience such symptoms. 

 
Not known: the frequency cannot be estimated from the available data 

- Bowel obstruction - a severe form of constipation with additional symptoms such as stomach 
ache, bloating or vomiting.  
You should see a doctor immediately if you experience such symptoms. 

 
Other side effects 
Very common: may affect more than 1 in 10 people 

- Nausea (feeling sick) 
- Vomiting (being sick) 
- Diarrhoea 
- Abdominal (stomach) pain. 

 
These side effects are usually not severe. They are most common when first starting dulaglutide but 
decrease over time in most patients. 
 

- Hypoglycaemia (low blood sugar) is very common when dulaglutide is used with medicines 
that contain metformin, a sulphonylurea and/or insulin. If you are taking a sulphonylurea or 
insulin, the dose may need to be lowered while you use dulaglutide. 

 
Common: may affect up to 1 in 10 people 

- Hypoglycaemia is common when dulaglutide is used alone, or with both metformin and 
pioglitazone together, or with a sodium-glucose co-transporter 2 inhibitor (SGLT2i) with or 
without metformin. 

- Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, feeling 
hungry, confusion, irritability, fast heartbeat and sweating. Your doctor should tell you how to 
treat low blood sugar. 

- Feeling less hungry (decreased appetite) 
- Indigestion 
- Constipation 
- Gas (flatulence) 
- Bloating of the stomach 
- Gastroesophageal reflux disease - a disease caused by stomach acid coming up into the tube 

from your stomach to your mouth 
- Burping 
- Feeling tired 
- Increased heart rate  
- Slowing of the electrical currents in the heart 

 
Uncommon: may affect up to 1 in 100 people 

- Injection site reactions (e.g. rash or redness) 
- Allergic reactions (hypersensitivity) (e.g. swelling, raised itchy skin rash (hives)) 
- Dehydration, often associated with nausea, vomiting and/or diarrhoea 
- Gallstones 
- Inflamed gallbladder 

 



94 

Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects, you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Trulicity 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the syringe label and on the carton 
after EXP. The expiry date refers to the last day of that month. 
 
Store in a refrigerator (2°C - 8°C). Do not freeze. 
 
Store in the original packaging in order to protect from light. 
 
Trulicity can be taken out of the fridge for up to 14 days at a temperature not above 30ºC. 
 
Do not use this medicine if you notice that the syringe is damaged, or the medicine is cloudy, 
discoloured or has particles in it. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Trulicity contains 
The active substance is dulaglutide. 
- Trulicity 0.75 mg: Each pre-filled syringe contains 0.75 mg of dulaglutide in 0.5 ml solution. 
- Trulicity 1.5 mg: Each pre-filled syringe contains 1.5 mg of dulaglutide in 0.5 ml solution. 

 
The other ingredients are sodium citrate (see section 2 under ‘Trulicity contains sodium citrate’ for 
further information); citric acid, anhydrous; mannitol; polysorbate 80 and water for injections. 
 
What Trulicity looks like and contents of the pack 
Trulicity is a clear, colourless, solution for injection in a pre-filled syringe. 
Each pre-filled syringe contains 0.5 ml solution. 
The pre-filled syringe is for single-use only. 
Pack sizes of 4 or multipacks of 12 (3 packs of 4) pre-filled syringes. Not all pack sizes may be 
available in your country. 
 
Marketing Authorisation Holder  
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
Manufacturer 
Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino, Firenze (FI), Italy 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


95 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 
 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 60 00 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 

Eesti 
Tel: +372 6 817 280 
 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges.m.b.H.  
Tel: + 43-(0) 1 711 780 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

France 
Lilly France SAS 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0)1 580 00 10 

Ísland 
Icepharma hf. 
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā 
Tel: +371 67364000 
 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
This leaflet was last revised in Month YYYY 



96 

 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  
 
 
-------------------------------------------------------------------------------------------------------------------------- 

http://www.ema.europa.eu/


97 

Instructions for use 
 

Trulicity 0.75 mg solution for injection in pre-filled pen 
dulaglutide 

 
  

 
 Unfold and lay flat  

 
Read both sides for full instructions 

 
 
 
ABOUT TRULICITY PRE-FILLED PEN 
 
Please read these Instructions for use and the Information for the patient carefully and 
completely before using your pre-filled pen. Talk to your doctor, pharmacist or nurse about how 
to inject Trulicity correctly. 
 
• The pen is a disposable, pre-filled delivery device that is ready to use. Each pen contains one 

weekly dose of Trulicity (0.75 mg). Each pen delivers one dose only. 
• Trulicity is administered once a week. You may want to mark your calendar to remind you 

when to inject your next dose. 
• When you press the green injection button, the pen will automatically insert the needle into 

your skin, inject the medicine, and pull back (retract) the needle after the injection is 
complete.  

 
 
  



98 

BEFORE YOU GET STARTED 
    
Remove Check 

 
Inspect 
 

Prepare 

from the refrigerator. 

Leave the Base Cap 
on until you are ready 
to inject. 

the label to make 
sure you have the 
correct medicine and 
it has not expired. 

the pen. Do not use if 
you notice that the pen 
is damaged, or the 
medicine is cloudy, 
discoloured or has 
particles in it.  
 

by washing your hands. 

 
 
CHOOSE YOUR INJECTION SITE 
 

 

  
 

• Your doctor, pharmacist or nurse can 
help you choose the injection site that is 
best for you. 

• You may inject the medicine into your 
stomach (abdomen) or thigh. 

• Another person may give you the 
injection in your upper arm. 

• Change (rotate) your injection site each 
week. You may use the same area of 
your body, but be sure to choose a 
different injection site in that area. 

 

FRONT BACK 



99 

1. UNCAP 
2. PLACE AND UNLOCK 
3. PRESS AND HOLD 
 

 
 
  



100 

1 UNCAP 
 

 Make sure the pen is locked. 
• Pull off and discard the grey 

base cap. 
 

Do not put the base cap back on – 
this could damage the needle. Do 
not touch the needle. 

 

 
 

 

2 PLACE AND UNLOCK 
 

• Place the clear base flat and 
firmly against your skin at the 
injection site. 

Unlock by turning the lock ring. 

 

  

3 PRESS AND HOLD 
 

• Press and hold the green 
injection button; you will 
hear a loud click. 

Continue holding the clear 
base firmly against your skin 
until you hear a second click. 
This occurs when the needle 
starts retracting in about 
5-10 seconds. 

• Remove the pen from your 
skin. 

 

 
 
  



101 

IMPORTANT INFORMATION 
 
Storage and Handling 
Disposal of Pen 
Commonly Asked Questions 
Other Information 
Where to Learn More 
 
 
STORAGE AND HANDLING 
 
• The pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. 

Use a new pen for your injection. 
• Store your pen in the refrigerator.  
• When refrigeration is not possible, you can keep your pen at room temperature (below 30°C) for 

up to a total of 14 days. 
• Do not freeze your pen. If the pen has been frozen, DO NOT USE. 
• Store the pen in the original package in order to protect from light. 
• Keep the pen out of sight and reach of children. 
• For complete information about proper storage, read the Information for the patient. 
 
DISPOSAL OF PEN 
 
• Dispose of the pen in a sharps 

container or as directed by your 
doctor, pharmacist or nurse.  

• Do not recycle the filled sharps 
container. 

• Ask your doctor, pharmacist or 
nurse about how to dispose of 
medicines you no longer use. 

 
 
 
 
  

 
 
COMMONLY ASKED QUESTIONS 
 
What if I see an air bubble in my pen? 
 
Air bubbles are normal. They will not harm you or affect your dose. 
 
What if I unlock the pen and press the green injection button before pulling off the base cap? 
 
Do not remove the base cap and do not use the pen. Dispose of the pen as directed by your doctor, 
pharmacist or nurse. Inject your dose using another pen. 
 
What if there is a drop of liquid on the tip of the needle when I remove the base cap? 
 
A drop of liquid on the tip of the needle is not unusual and will not affect your dose. 
 
Do I need to hold the injection button down until the injection is complete? 
 
This is not necessary, but it may help you keep the pen steady and firm against your skin. 
 



102 

I heard more than two clicks during my injection - two louder clicks and a soft one. Did I get my 
complete injection? 
 
Some patients may hear a soft click right before the second loud click. That is the normal operation of 
the pen. Do not remove the pen from your skin until you hear the second louder click. 
 
What if there is a drop of liquid or blood on my skin after my injection? 
 
This is not unusual and will not affect your dose. 
 
I’m not sure my pen worked correctly. 
 
Check to see if you have received your dose. Your dose was delivered correctly if the grey part is 
visible (see step 3.) Also contact your local Lilly office listed in the Information for the patient for 
further instructions. Until then, store your pen safely to avoid an accidental needle stick injury. 
 
 
OTHER INFORMATION 
 
• If you have vision problems, DO NOT use your pen without help from a person trained to use 

the Trulicity pen. 
 
 
WHERE TO LEARN MORE 
 
• If you have any questions or problems with your Trulicity pen, contact your doctor, pharmacist 

or nurse. 
 
 

 

SCAN THIS CODE TO LAUNCH  
www.trulicity.eu 

 
Last revised in Month YYYY 



103 

  
Instructions for use 

 
Trulicity 1.5 mg solution for injection in pre-filled pen 

dulaglutide 

 
 

 
 Unfold and lay flat  

 
Read both sides for full instructions 

 
 
 
ABOUT TRULICITY PRE-FILLED PEN 
 
Please read these Instructions for use and the Information for the patient carefully and 
completely before using your pre-filled pen. Talk to your doctor, pharmacist or nurse about how 
to inject Trulicity correctly. 
 
• The pen is a disposable, pre-filled delivery device that is ready to use. Each pen contains one 

weekly dose of Trulicity (1.5 mg). Each pen delivers one dose only. 
• Trulicity is administered once a week. You may want to mark your calendar to remind you 

when to inject your next dose. 
• When you press the green injection button, the pen will automatically insert the needle into 

your skin, inject the medicine, and pull back (retract) the needle after the injection is 
complete.  

 
 
  



104 

BEFORE YOU GET STARTED 
    
Remove Check 

 
Inspect 
 

Prepare 

from the refrigerator. 

Leave the Base Cap 
on until you are ready 
to inject. 

the label to make 
sure you have the 
correct medicine and 
it has not expired. 

the pen. Do not use if 
you notice that the pen 
is damaged, or the 
medicine is cloudy, 
discoloured or has 
particles in it.  
 

by washing your hands. 

 
 
CHOOSE YOUR INJECTION SITE 
 

 

 
 

• Your doctor, pharmacist or nurse can 
help you choose the injection site that is 
best for you. 

• You may inject the medicine into your 
stomach (abdomen) or thigh. 

• Another person may give you the 
injection in your upper arm. 

• Change (rotate) your injection site each 
week. You may use the same area of 
your body, but be sure to choose a 
different injection site in that area. 

 

FRONT BACK 



105 

1. UNCAP 
2. PLACE AND UNLOCK 
3. PRESS AND HOLD 

 

 

  



106 

1 UNCAP 
 

 Make sure the pen is locked. 
• Pull off and discard the grey base 

cap. 
 
Do not put the base cap back on – this 
could damage the needle. Do not 
touch the needle. 

 
 
  

2 PLACE AND UNLOCK 
 

• Place the clear base flat and 
firmly against your skin at the 
injection site. 

Unlock by turning the lock ring. 

 

 
  

3 PRESS AND HOLD 
 

• Press and hold the green injection 
button; you will hear a loud click. 

Continue holding the clear base 
firmly against your skin until you 
hear a second click. This occurs 
when the needle starts retracting 
in about 5-10 seconds. 

• Remove the pen from your skin. 
 

 

 
  



107 

IMPORTANT INFORMATION 
 
Storage and Handling 
Disposal of Pen 
Commonly Asked Questions 
Other Information 
Where to Learn More 
 
 
STORAGE AND HANDLING 
 
• The pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. 

Use a new pen for your injection. 
• Store your pen in the refrigerator.  
• When refrigeration is not possible, you can keep your pen at room temperature (below 30°C) for 

up to a total of 14 days.  
• Do not freeze your pen. If the pen has been frozen, DO NOT USE. 
• Store the pen in the original package in order to protect from light. 
• Keep the pen out of sight and reach of children. 
• For complete information about proper storage, read the Information for the patient. 
 
 
DISPOSAL OF PEN 
 
• Dispose of the pen in a sharps 

container or as directed by your 
doctor, pharmacist or nurse.  

• Do not recycle the filled sharps 
container. 

• Ask your doctor, pharmacist or 
nurse about how to dispose of 
medicines you no longer use. 

 
 
 
 
  

 
 
 
 
COMMONLY ASKED QUESTIONS 
 
What if I see an air bubble in my pen? 
 
Air bubbles are normal. They will not harm you or affect your dose. 
 
What if I unlock the pen and press the green injection button before pulling off the base cap? 
 
Do not remove the base cap and do not use the pen. Dispose of the pen as directed by your doctor, 
pharmacist or nurse. Inject your dose using another pen. 
 
What if there is a drop of liquid on the tip of the needle when I remove the base cap? 
 
A drop of liquid on the tip of the needle is not unusual and will not affect your dose. 
 
Do I need to hold the injection button down until the injection is complete? 



108 

 
This is not necessary, but it may help you keep the pen steady and firm against your skin. 
 
I heard more than two clicks during my injection - two louder clicks and a soft one. Did I get my 
complete injection? 
 
Some patients may hear a soft click right before the second loud click. That is the normal operation of 
the pen. Do not remove the pen from your skin until you hear the second louder click. 
 
What if there is a drop of liquid or blood on my skin after my injection? 
 
This is not unusual and will not affect your dose. 
 
I’m not sure my pen worked correctly. 
 
Check to see if you have received your dose. Your dose was delivered correctly if the grey part is 
visible (see step 3.) Also contact your local Lilly office listed in the Information for the patient for 
further instructions. Until then, store your pen safely to avoid an accidental needle stick injury. 
 
 
OTHER INFORMATION 
 
• If you have vision problems, DO NOT use your pen without help from a person trained to use 

the Trulicity pen. 
 
 
WHERE TO LEARN MORE 
 
• If you have any questions or problems with your Trulicity pen, contact your doctor, pharmacist 

or nurse. 
 

 

SCAN THIS CODE TO LAUNCH  
www.trulicity.eu 

 

 
 

 
Last revised in Month YYYY 



109 

 Instructions for use 
 

Trulicity 0.75 mg solution for injection in pre-filled syringe 
 

dulaglutide 
 
 
 
 

 
 

 Unfold and lay flat  

 
Read both sides for full instructions 

 
 
ABOUT TRULICITY PRE-FILLED SYRINGE 
 
Please read these Instructions for use and the Information for the patient carefully and 
completely before using your pre-filled syringe. 
 
• The syringe is a disposable, pre-filled delivery device. Each syringe contains one weekly dose 

of Trulicity (0.75 mg). Each syringe delivers one dose only. 
• Trulicity is administered once a week. You may want to mark your calendar to remind you 

when to inject your next dose. 
 
 
BEFORE YOU GET STARTED 
    
Remove Check Inspect Prepare 
 
from the refrigerator. 

 
the label to make sure 
you have the correct 
medicine and it has 
not expired. 

 
the syringe. Do not use 
if you notice that the 
syringe is damaged, or 
the medicine is cloudy, 
discoloured or has 
particles in it.  
 

 
by washing your 
hands. 

 



110 

CHOOSE YOUR INJECTION SITE 
 
• Your doctor, pharmacist or nurse can 

help you choose the injection site that 
is best for you. 

• You may inject the medicine into your 
stomach (abdomen) or thigh. 

• Another person may give you the 
injection in your upper arm. 

• Change (rotate) your injection site 
each week. You may use the same 
area of your body, but be sure to 
choose a different injection site in that 
area. 

  
 
 
1. UNCAP 
 
2. INSERT 
 
3. INJECT 

 

  

 

 
 

 

FRONT BACK 

Plunger Rod 

Plunger 

Medicine 

Needle 
Cover 



111 

1 UNCAP 
 
• Pull off and discard the needle 

cover. 
 
 Do not touch the needle. 

 

2 INSERT 
 
• Gently grasp a fold of skin at the 

injection site. 
• Insert the needle into your skin 

at about a 45-degree angle. 

 

 

3 INJECT 
 
• Slowly push the plunger all the 

way in until all the medicine is 
injected. 

• Remove the needle from your 
skin. 

• Gently let go of the fold of skin. 

 

 



112 

IMPORTANT INFORMATION 
 
Storage and Handling 
Disposal of Syringe 
Commonly Asked Questions 
Other Information 
Where to Learn More 
 
 
STORAGE AND HANDLING 
 
• Store your syringe in the refrigerator. 
• When refrigeration is not possible, you can keep your syringe at room temperature 

(below 30°C) for up to a total of 14 days. 
• Do not freeze your syringe. If the syringe has been frozen, DO NOT USE. 
• Keep the syringe out of sight and reach of children. 
• Store the syringe in the original package in order to protect from light. 
 
For complete information about proper storage, read the Information for the patient. 
 
 
DISPOSAL OF SYRINGE 
 
• Do not put the needle cover back 

on – this may result in an 
accidental needle stick injury to 
your hand. 

• Dispose of the syringe in a 
sharps container or as directed by 
your doctor, pharmacist or nurse  

• Do not recycle the filled sharps 
container. 

• Ask your doctor, pharmacist or 
nurse about how to dispose of 
medicines you no longer use. 

• The directions regarding syringe 
handling and disposal are not 
intended to replace local or 
institutional policies. 

 

 
 
COMMONLY ASKED QUESTIONS 
 
What if the needle looks bent? 
 
• Do not use your syringe. 
• Do not touch the needle. 
• Dispose of the syringe as directed. 
• Inject your dose using another syringe. 
 
What if I see an air bubble in my Syringe? 
 
Air bubbles are normal. They will not harm you or affect your dose. 
 
I don’t know how to do a subcutaneous injection. 
 



113 

You should receive training from your doctor, pharmacist or nurse on the right way to prepare and 
inject your medicine. Gently grasp a fold of skin at the injection site. With your other hand, hold the 
syringe like a pencil. Insert the needle into your skin at about a 45-degree angle. Slowly push the 
plunger all the way in until all the medicine is injected. Remove the needle from the skin. Gently 
release the skin. 
 
What if there is a drop of liquid on the tip of the needle when I remove the needle cover? 
 
Drops of liquid on the tip of the needle are not unusual and will not affect your dose. 
 
What if I cannot push in the plunger? 
 
• Do not continue to use your syringe. 
• Remove the needle from your skin. 
• Dispose of the syringe as directed. 
• Inject your dose using another syringe. 
 
How can I tell if I have completed my injection? 
 
When your injection is complete, the plunger should be pushed fully into the syringe, with no more 
medicine left in it. 
 
What if there is a drop of liquid or blood on my skin after my injection? 
 
This is not unusual and will not affect your dose. 
 
 
OTHER INFORMATION 
 
• If you have vision problems, DO NOT use your syringe without help from a person trained to 

use the Trulicity syringe. 
• Do not share your syringe with anyone else. You may give them an infection or get an infection 

from them. 
 
 
WHERE TO LEARN MORE 
 
• If you have any questions or problems with your Trulicity syringe, contact your doctor, 

pharmacist or nurse. 
 
 
Last revised in Month YYYY 



114 

 Instructions for use 
 

Trulicity 1.5 mg solution for injection in pre-filled syringe 
 

dulaglutide 
 
 
 
 

 
 

 Unfold and lay flat  

 
Read both sides for full instructions 

 
ABOUT TRULICITY PRE-FILLED SYRINGE 
 
Please read these Instructions for use and the Information for the patient carefully and 
completely before using your pre-filled syringe. 
 
• The syringe is a disposable, pre-filled delivery device. Each syringe contains one weekly dose 

of Trulicity (1.5 mg). Each syringe delivers once dose only. 
• Trulicity is administered once a week. You may want to mark your calendar to remind you 

when to inject your next dose. 
 
 
BEFORE YOU GET STARTED 
    
Remove Check Inspect Prepare 
 
from the refrigerator. 

 
the label to make sure 
you have the correct 
medicine and it has 
not expired. 

 
the syringe. Do not use 
if you notice that the 
syringe is damaged, or 
the medicine is cloudy, 
discoloured or has 
particles in it.  
 

 
by washing your 
hands. 

 



115 

CHOOSE YOUR INJECTION SITE 
 
• Your doctor, pharmacist or nurse can 

help you choose the injection site that 
is best for you. 

• You may inject the medicine into your 
stomach (abdomen) or thigh. 

• Another person may give you the 
injection in your upper arm. 

• Change (rotate) your injection site 
each week. You may use the same 
area of your body, but be sure to 
choose a different injection site in that 
area. 

 
 
 
1. UNCAP 
 
2. INSERT 
 
3. INJECT 

 

 

 

. 
 

 

FRONT BACK 

Plunger Rod 

Plunger 

Medicine 

Needle 
Cover 



116 

1 UNCAP 
 
• Pull off and discard the needle 

cover. 
 
 Do not touch the needle. 

 
2 INSERT 
 
• Gently grasp a fold of skin at the 

injection site. 
• Insert the needle into your skin 

at about a 45-degree angle. 

 

 

3 INJECT 
 
• Slowly push the plunger all the 

way in until all the medicine is 
injected. 

• Remove the needle from your 
skin. 

• Gently let go of the fold of skin. 

 

 



117 

IMPORTANT INFORMATION 
 
Storage and Handling 
Disposal of Syringe 
Commonly Asked Questions 
Other Information 
Where to Learn More 
 
 
STORAGE AND HANDLING 
 
• Store your syringe in the refrigerator. 
• When refrigeration is not possible, you can keep your syringe at room temperature 

(below 30°C) for up to a total of 14 days. 
• Do not freeze your syringe. If the syringe has been frozen, DO NOT USE.  
• Keep the syringe out of sight and reach of children. 
• Store the syringe in the original package in order to protect from light. 
 
For complete information about proper storage, read the Information for the patient. 
 
 
DISPOSAL OF SYRINGE 
 
• Do not put the needle cover back 

on – this may result in an 
accidental needle stick injury to 
your hand. 

• Dispose of the syringe in a 
sharps container or as directed by 
your doctor, pharmacist or nurse  

• Do not recycle the filled sharps 
container. 

• Ask your doctor, pharmacist or 
nurse about how to dispose of 
medicines you no longer use. 

• The directions regarding syringe 
handling and disposal are not 
intended to replace local or 
institutional policies. 

 

 
 
COMMONLY ASKED QUESTIONS 
 
What if the needle looks bent? 
 
• Do not use your syringe. 
• Do not touch the needle. 
• Dispose of the syringe as directed. 
• Inject your dose using another syringe. 
 
What if I see an air bubble in my syringe? 
 
Air bubbles are normal. They will not harm you or affect your dose. 
 
I don’t know how to do a subcutaneous injection. 
 



118 

You should receive training from your doctor, pharmacist or nurse on the right way to prepare and 
inject your medicine. Gently grasp a fold of skin at the injection site. With your other hand, hold the 
syringe like a pencil. Insert the needle into your skin at about a 45-degree angle. Slowly push the 
plunger all the way in until all the medicine is injected. Remove the needle from the skin. Gently 
release the skin. 
 
What if there is a drop of liquid on the tip of the needle when I remove the needle cover? 
 
Drops of liquid on the tip of the needle are not unusual and will not affect your dose. 
 
What if I cannot push in the plunger? 
 
• Do not continue to use your syringe. 
• Remove the needle from your skin. 
• Dispose of the syringe as directed. 
• Inject your dose using another syringe. 
 
How can I tell if I have completed my injection? 
 
When your injection is complete, the plunger should be pushed fully into the syringe, with no more 
medicine left in it. 
 
What if there is a drop of liquid or blood on my skin after my injection? 
 
This is not unusual and will not affect your dose. 
 
 
OTHER INFORMATION 
 
• If you have vision problems, DO NOT use your syringe without help from a person trained to 

use the Trulicity syringe. 
• Do not share your syringe with anyone else. You may give them an infection or get an infection 

from them. 
 
 
WHERE TO LEARN MORE 
 
• If you have any questions or problems with your Trulicity syringe, contact your doctor, 

pharmacist or nurse. 
 
 
Last revised in Month YYYY  

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET