Clinical trial NCT01336023: Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes
Official title: A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Treated With 1-2 Oral Anti-diabetic Drugs (OADs)With a 26 Week Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-04-15
Enrollment: 1663
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted globally. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide (Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment with metformin or metformin + pioglitazone throughout the entire trial.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes
* HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly, when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%
* Male or female, age 18 years or above (Taiwan: 20 years or above for a site 653 in Taiwan: Taichung Veterans General Hospital)
* Subjects on stable dose of 1-2 OADs (metformin \[at least 1500 mg or max tolerated dose\] or metformin \[at least 1500 mg or max tolerated dose\] + pioglitazone \[at least 30 mg\]) for at least 90 days prior to screening
* Body Mass Index (BMI) maximum 40 kg/m\^2

Exclusion Criteria:

* Treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator)
* Treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90 days prior to trial
* Impaired liver function, defined as alanine aminotransferese (ALAT) at least 2.5 times Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
* Impaired renal function defined as serum-creatinine at least 133 mcmol/l (at least 1.5 mg/dl) for males and at least 125 mcmol/l (at least 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive)
* Screening calcitonin at least 50 ng/L
* Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
* Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months and planned coronary, carotid or peripheral artery revascularisation procedures
* Severe uncontrolled treated or untreated hypertension (systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 100 mm Hg)
* Acute treatment required proliferative retinopathy or maculopathy (macular oedema)
* History of chronic pancreatitis or idiopathic acute pancreatitis

Primary outcomes:
measure: Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.
timeFrame: Week 0, week 26
Secondary outcomes:
measure: Mean Change From Baseline in Body Weight at Week 26
timeFrame: Week 0, Week 26
measure: Number of Hypoglycaemic Episodes
timeFrame: Weeks 0-26
measure: Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test
timeFrame: Week 0, Week 26
measure: Mean Actual Daily Insulin Dose
timeFrame: Week 26
Other outcomes:
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city: Flemington
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city: Toms River
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city: Hamilton
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country: India
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city: Patna
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country: Ireland
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city: Galway
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country: Italy
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city: Forlì
country: Italy
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city: Monserrato, Cagliari
country: Italy
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city: Novara
country: Italy
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city: Olbia
country: Italy
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city: Palermo
country: Italy
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city: Siena
country: Italy
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city: Torino
country: Italy
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city: Cheras
country: Malaysia
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city: Kota Bharu, Kelantan
country: Malaysia
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country: Malaysia
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city: Pulau Pinang
country: Malaysia
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city: Putrajaya
country: Malaysia
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city: Seremban
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Guadalajara
country: Mexico
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state: Jalisco
city: Monterrey
country: Mexico
facility: Novo Nordisk Investigational Site
state: Nuevo León
city: San Juan
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Kursk
country: Russian Federation
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city: Moscow
country: Russian Federation
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city: Moscow
country: Russian Federation
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city: Penza
country: Russian Federation
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city: Saint-Petersburg
country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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city: Saratov
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Stavropol
country: Russian Federation
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city: Voronezh
country: Russian Federation
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city: Vsevolozhsk
country: Russian Federation
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city: Singapore
country: Singapore
facility: Novo Nordisk Investigational Site
city: Singapore
country: Singapore
facility: Novo Nordisk Investigational Site
city: Singapore
country: Singapore
facility: Novo Nordisk Investigational Site
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Lucenec
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Moldava nad Bodvou
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Nove Zamky
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Port Elizabeth
country: South Africa
facility: Novo Nordisk Investigational Site
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: Novo Nordisk Investigational Site
state: Free State
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Vaderbijlpark
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Umkomaas
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Brits
country: South Africa
facility: Novo Nordisk Investigational Site
state: North West
city: Cape Town
country: South Africa
facility: Novo Nordisk Investigational Site
state: Western Cape
city: Almería
country: Spain
facility: Novo Nordisk Investigational Site
city: Granada
country: Spain
facility: Novo Nordisk Investigational Site
city: La Coruña
country: Spain
facility: Novo Nordisk Investigational Site
city: Partida De Bacarot
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Valladolid
country: Spain
facility: Novo Nordisk Investigational Site
city: Taichung City
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Tainan city
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Taipei
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Taoyuan
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Bangkoknoi, Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Chiang Mai
country: Thailand
facility: Novo Nordisk Investigational Site
city: Belfast
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bury St Edmunds
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Carmarthen
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Dundee
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Edgbaston, Birmingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Fife
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Glasgow
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Gloucester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Headington
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Lancaster
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Letchworth
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Llantrisant
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: St Helens
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Stevenage
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Weston Super Mare
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Wrexham
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Khunti K, Mohan V, Jain SM, Boesgaard TW, Begtrup K, Sethi B. Efficacy and Safety of IDegLira in Participants with Type 2 Diabetes in India Uncontrolled on Oral Antidiabetic Drugs and Basal Insulin: Data from the DUAL Clinical Trial Program. Diabetes Ther. 2017 Jun;8(3):673-682. doi: 10.1007/s13300-017-0252-9. Epub 2017 Mar 22.
citation: Holst JJ, Buse JB, Rodbard HW, Linjawi S, Woo VC, Boesgaard TW, Kvist K, Gough SC. IDegLira Improves Both Fasting and Postprandial Glucose Control as Demonstrated Using Continuous Glucose Monitoring and a Standardized Meal Test. J Diabetes Sci Technol. 2015 Oct 6;10(2):389-97. doi: 10.1177/1932296815610124.
citation: Vilsboll T, Vora J, Jarlov H, Kvist K, Blonde L. Type 2 Diabetes Patients Reach Target Glycemic Control Faster Using IDegLira than Either Insulin Degludec or Liraglutide Given Alone. Clin Drug Investig. 2016 Apr;36(4):293-303. doi: 10.1007/s40261-016-0376-0.
citation: Gough SC, Bode B, Woo V, Rodbard HW, Linjawi S, Poulsen P, Damgaard LH, Buse JB; NN9068-3697 (DUAL-I) trial investigators. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes. Lancet Diabetes Endocrinol. 2014 Nov;2(11):885-93. doi: 10.1016/S2213-8587(14)70174-3. Epub 2014 Sep 1.
citation: Gough SC, Bode BW, Woo VC, Rodbard HW, Linjawi S, Zacho M, Reiter PD, Buse JB. One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial. Diabetes Obes Metab. 2015 Oct;17(10):965-73. doi: 10.1111/dom.12498. Epub 2015 Jul 1.
citation: Kapitza C, Bode B, Ingwersen SH, Jacobsen LV, Poulsen P. Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy. J Clin Pharmacol. 2015 Dec;55(12):1369-77. doi: 10.1002/jcph.549. Epub 2015 Jul 14.
citation: King AB, Philis-Tsimikas A, Kilpatrick ES, Langbakke IH, Begtrup K, Vilsboll T. A Fixed Ratio Combination of Insulin Degludec and Liraglutide (IDegLira) Reduces Glycemic Fluctuation and Brings More Patients with Type 2 Diabetes Within Blood Glucose Target Ranges. Diabetes Technol Ther. 2017 Apr;19(4):255-264. doi: 10.1089/dia.2016.0405. Epub 2017 Mar 10.
citation: Norwood P, Chen R, Jaeckel E, Lingvay I, Jarlov H, Lehmann L, Heller S. Rates of hypoglycaemia are lower in patients treated with insulin degludec/liraglutide (IDegLira) than with IDeg or insulin glargine, regardless of the hypoglycaemia definition used. Diabetes Obes Metab. 2017 Nov;19(11):1562-1569. doi: 10.1111/dom.12972. Epub 2017 Jul 10.