Clinical trial NCT03013985
Conditions: Type 2 Diabetes
Keywords: Blood glucose
Sponsor: Emory University
Start date: 2017-05-17; Completion date: 2019-03-22
Enrollment: 247 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out if treatment with Glargine U300 when compared to Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D), who are admitted to the hospital and then transition at home, after discharge from the hospital.

Detailed description:
Several randomized clinical trials done previously in medicine and surgical patients with T2D have shown that basal bolus regimen with glargine results in a lower mean daily blood glucose (BG) concentrations compared to the sole use of sliding scale regular insulin (SSI) and in lower rate of hospital complications. Glargine U300 results in similar improvement but in lower rate of hypoglycemia than treatment with glargine U100. No previous studies; however, have compared the efficacy and safety of glargine U300 in the management of hyperglycemia and diabetes in the hospital setting. This study will determine if treatment with glargine U300 has a similar glucose control in patients with diabetes admitted to the hospital and if glargine U300 will result in lower number of low blood sugars compared to glargine U100 .

Arms: arm 1: Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held. arm 2: Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.
Interventions: intervention 1: Glargine U300 intervention 2: Glargine U100 intervention 3: Glulisine Insulin
Intervention descriptions: intervention 1: Glargine U300 is a new generation long-acting insulin. intervention 2: Glargine U100 is a long-acting insulin. intervention 3: Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.

Protocol documents:
Prot_SAP_000.pdf: 
Glargine U300 vs U100_ Hospital Trial 
01/28/2019 
 
 
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IRB00091740 
 
NCT03013985 
 
A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient and Post-
Hospital Discharge Management of Medicine and Surgery Patients with Type 2 Diabetes 
 
 
Principal Investigator: 
 
 
Guillermo E. Umpierrez, M.D. 
Professor of Medicine, Endocrinology  
Emory University School of Medicine 
Director, Diabetes and Endocrinology Section 
 
 
 
 
Grady Health System 
 
01/28/2019 
 
 
 


Glargine U300 vs U100_ Hospital Trial 
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Title:   
 
Glargine U300 Hospital Trial: A Randomized Controlled Trial Comparing Glargine U300 and Glargine 
U100 for the Inpatient and Post-Hospital Discharge Management of Medicine and Surgery Patients with 
Type 2 Diabetes  
 
Principal Investigator: 
 
 
Guillermo E. Umpierrez, M.D. 
Professor of Medicine, Endocrinology  
Emory University School of Medicine 
Director, Diabetes and Endocrinology Section 
 
 
 
 
Grady Health System 
 
Co-Principal Investigator: 
 
 
 
 
Francisco J Pasquel, MD, MPH 
Assistant Professor of Medicine, Endocrinology  
Emory University School of Medicine 
 
 
Investigators: 
Emory University, Atlanta  
  Priyathama Vellanki, MD   
  Maya Fayfman, MD 
  Sonya Haw, MD 
  Sol Jacobs, MD 
  Rodolfo J Galindo, MD 
 
 
Minneapolis Medical Research Foundation-Hennepin Medical Center, Minneapolis 
 Ameer Ali Khowaja, MD 
 
The Cleveland Clinic Foundation, Ohio 
 Cecilia Lansang, MD 


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I. 
RESEARCH OBJECTIVES AND SPECIFIC AIMS 
 
A. 
Introduction: 
The association between hyperglycemia and poor clinical outcomes in hospitalized patients with 
and without diabetes is well established (1-5). Extensive data from observational and prospective 
randomized controlled trials (RCT) in hospitalized patients have reported a strong association between 
hyperglycemia and poor clinical outcome, such as increased mortality, morbidity, hospital length of stay 
(LOS), infections and overall complications (1, 4, 6-8).  Clinical trials in both critically ill and in non-ICU 
medicine and surgery patients have shown that improvement of glycemic control in patients with 
hyperglycemia reduces LOS, systemic infections (9-11) and short- and long-term mortality (6, 11).   
 
Randomized multi-center trials have shown that basal bolus treatment with glargine U100 improve 
glycemic control and reduce the rate of hospital complications compared to sliding scale regular insulin 
(SSI) (12-14). In general surgery patients, the basal bolus approach results in significant reduction in a 
composite of hospital complications including postoperative wound infection, pneumonia, bacteremia, 
and acute renal and respiratory failure (15). The hospital hypoglycemia rate was reported in 3% in 
medicine (16) and 12% in surgery (17) patients treated with basal bolus regimen. Based on these results, 
clinical practice guidelines have recommended the use of basal bolus approach as the preferred insulin 
regimen for the management of non-ICU patients with diabetes (18-20).  
 
The Food and Drug Administration and the European Commission recently approved Glargine 
U300 insulin for the treatment of patients with diabetes. Glargine U300 is long-acting insulin with 
duration of action longer than 24 hours (21, 22). The results of the Edition clinical trials with more than 
3500 patients demonstrated that glargine U300 resulted in similar improvement in glycemic control and 
with a lower rate of nocturnal hypoglycemia compared to glargine U100 (23-27). The efficacy and safety 
of glargine U300 has been documented in patients with type 1 and type 2 diabetes (22-27); however, no 
previous studies have assessed the safety and efficacy of these new formulations in the inpatient (hospital) 
setting. In addition, certain features of glargine U300 needs to be investigated in the hospital including 1) 
prolonged duration of action, which may limit the ability to make day-to-day adjustments in insulin 
dosage; 2) a steady-state insulin concentration achieved after second or third day of therapy; and limited 
safety data in acutely ill patients with altered nutritional status. Accordingly, the present randomized 
clinical trial will compare the efficacy and safety of a basal bolus regimen with glargine U300 and 
glargine U100 (standard of care) in general medicine and surgery patients with T2D. 
 
B. 
Specific Aims:   
Aim 1.  To determine differences in inpatient glycemic control, as measured by mean daily blood 
glucose concentration and frequency of hypoglycemia, in general medicine and surgery patients 
with T2D treated with basal bolus regimen with glargine U300 and U100 plus glulisine insulin 
before meals. 
Hypothesis: Treatment with glargine U300 will result in equivalent glycemic control in hospitalized 
patients with T2D. Glargine U300 will result in lower number of hypoglycemia compared to glargine. 
 
Aim 2:  To determine differences in glycemic control after hospital discharge between treatment 
with glargine U300 and glargine U100 in medicine and surgery patients T2D.  Patients with poorly 
controlled diabetes (HbA1c ≥7.5%) enrolled in Aim 1 will be invited to participate in this open label 
prospective outpatient study. The total duration of the study is 3 months. Patients with an HbA1c between 
7.5% and 10% will be discharged on preadmission oral antidiabetic agents plus glargine U300 and U100 
once daily. Patients with an admission A1C ≥ 10% will be discharged on basal bolus regimen with 
glargine and glulisine insulin before meals.   


Glargine U300 vs U100_ Hospital Trial 
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Hypothesis: treatment with glargine U300 and U100 will result in a similar improvement in HbA1c levels 
after hospital discharge. Glargine U300 will result in lower number of hypoglycemia compared to U100. 
II. 
BACKGROUND AND CURRENT STATUS OF WORK IN THE FIELD. 
 
Inpatient glycemic control in non-ICU setting.  A large body of evidence has shown that in 
hospitalized patients, the presence of hyperglycemia and diabetes is associated with increased risk of 
complications and death (1-6, 28-31). Several randomized multi-center trials have shown that the use of 
basal bolus insulin regimen result in improved glycemic control and reduced rate of hospital 
complications compared to sliding scale regular insulin (SSI) in patients with T2D (12-14). We have 
reported that treatment with basal and basal bolus regimens using glargine U100 results in greater 
improvement in BG control and a reduction in the frequency of hospital complications including 
postoperative wound infection, pneumonia, bacteremia, and acute renal and respiratory failure compared 
to SSI treatment.(16, 17, 32, 33) In addition, the use of basal bolus regimen with glargine U100 is safe 
with low rate of hypoglycemic events. Based on these studies and others, clinical practice guidelines for 
the management of hyperglycemia in non-ICU setting have favored the use of basal prandial insulin 
regimens with insulin analogs for most inpatients with T2D (6, 19, 31).   
 
Efficacy and safety of new glargine U-300 insulin:  
Glargine U300 insulin has a peakless pharmacodynamic profile with duration of action longer than 
24 hours. Several clinical trials in the Edition clinical program, which included more than 3500 patients 
with type 2 diabetes treated with basal insulin or with oral agents demonstrated that glargine U300 
treatment resulted in similar improvement in glycemic control (HbA1c reduction) compared to glargine 
U100 insulin (23-27). In addition, patients treated with glargine U300 experienced lower rates of 
hypoglycemia, in particular nocturnal hypoglycemia compared to glargine U100 (23-27).  The safety 
profile of glargine U300 makes these new insulin formulations an attractive alternative to glargine U100, 
as hypoglycemia has been associated with increased risk of complications and mortality in the hospital 
setting (34, 35). 
 
No previous studies have determined the safety and efficacy of glargine U300 compared to 
glargine U100 (current standard of care) in hospitalized patients with diabetes. Despite the benefit in 
improving glycemic control and in reducing hypoglycemia, there are potential concerns with the use of 
this new basal insulin formulation in the hospital due to its prolonged duration of action and time to 
achieve a steady-state concentration in patients with altered nutrition.  The anticipated large number of 
patients who will be treated with glargine U300 in the future, makes this proposal timely and of great 
clinical interest. 
 
Transition Care from Hospital to Home. Hospital discharge represents a critical time for ensuring a 
safe transition to the outpatient setting and reducing the need for emergency department visits and re-
hospitalization.  Few studies have addressed the management of patients with diabetes after hospital 
discharge in insulin treated patients with T2D.  The Endocrine Society guidelines for the management of 
hyperglycemia recently recommended the use of HbA1c concentration during the hospital stay in tailoring 
the glycemic management of diabetic patients at discharge (19). In a recent study we assessed the efficacy 
of an HbA1c based algorithm using glargine insulin for the management of patients with T2D (see 
preliminary results section) (36). Patients with an HbA1c between 7% and 9% were discharged on a 
combination of OADs and glargine insulin at 50% of total daily hospital dose. Patients with an admission 
HbA1c ≥ 9% were discharged on a combination of OAD and glargine insulin at 80% of total daily 
hospital dose or on a basal bolus regimen with glargine and rapid-acting insulin analog before meals. The 
admission HbA1c on admission of 8.75% decreased to 7.9% and 7.35% after 4 and 12 weeks of hospital 
discharge (p<0.01). The rate of hypoglycemia was ~30% in patients treated with oral agents plus basal 
insulin and greater than 40% in patients treated with basal bolus insulin regimen.  It is expected that 


Glargine U300 vs U100_ Hospital Trial 
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glargine U300, which is known to have lower rate of hypoglycemia compared to glargine U100, will 
reduce the rate of hypoglycemia after hospital discharge. 
 
Significance and Innovation. Glargine U300 is a new generation basal insulin analog with a longer 
duration of action compared to insulin glargine (21, 22). Several outpatient trials have reported that 
treatment with glargine U300 results in comparable improvement in HbA1c levels and in lower rates of 
hypoglycemia compared to glargine U100 insulin (23-27). No previous studies; however, have compared 
the safety and efficacy of the long-acting glargine U300 in the inpatient management of patients with 
diabetes. It is expected that a large number of patients with diabetes will be started or transitioned to this 
new insulin formulation; so acquiring knowledge on their safety and efficacy is of great clinical interest. 
Accordingly, the proposed study will provide novel and clinically useful information on the efficacy (BG 
control) and safety (hypoglycemia) of glargine U300 in the inpatient setting and after hospital discharge 
in general medicine and surgery patients with T2D.  
 
III. 
PRELIMINARY RESULTS: 
 
Our groups have reported the results of several 
observational and  prospective, randomized multi-center 
trials comparing the efficacy and safety of basal/bolus insulin 
regimens to sliding scale regular insulin (SSI) and split-
mixed regimen with NPH/regular in T2D patients admitted to 
general medicine services (16, 17).   
 
In the Rabbit trial (Fig 1), 130 nonsurgical insulin naïve 
patients were randomized to receive glargine once daily and 
glulisine before meals or SSRI before meals and at bedtime. 
Patients treated with glargine/glulisine had greater 
improvement in BG control than SSRI with a minimal risk of 
hypoglycemia patients (3% of patients in each group had a 
BG < 60 mg/dL). A BG target of <140 mg/dL was achieved 
in 66% of patients treated with glargine and glulisine whereas 
only 38% of those treated with SSRI achieved target glycemia.   
 
In the Rabbit-Surgery trial (Figure 2), 211 general non-cardiac 
surgery patients with T2D were randomized to a basal bolus 
(BB) with glargine once daily and glulisine before meals and to 
sliding scale regular insulin (SSI). Study outcomes included 
differences in daily BG levels and a composite of hospital 
complications including postoperative wound infection, 
pneumonia, respiratory failure, acute renal failure, and 
bacteremia. The mean daily glucose after the 1st day of BB and 
SSI was 145±32 mg/dl and 172±47 mg/dl, respectively, p<0.01. 
BG readings <140 mg/dl were recorded in 55% of patients in BB 
and 31% in the SSI group, p<0.001.  There were reductions with 
BB as compared with SSI in the composite outcome (24.3% and 
8.6%, OR: 3.39 (95% CI: 1.50-7.65); p=0.003).  We concluded 
that treatment with BB improved glycemic control and reduced 
complications compared to SSI in surgery patients with T2D. 
 
Basal insulin during Hospital Discharge.(36)  
Fig 1 
A1C < 7% 
Re-start 
outpatient 
treatment 
regimen 
(OAD and/or 
insulin) 
A1C 7%-9% 
Re-start 
outpatient oral 
agents and D/C 
on glargine once 
daily at 50% of 
hospital dose  
A1C >9% 
D/C on basal bolus at 
same hospital dose. 
Alternative: re-start 
oral agents and D/C 
on glargine once 
daily at 80% of 
hospital dose  
Discharge Treatment 
Umpierrez et al.  ADA Scientific Meeting, Philadelphia 2012 
Fig 3 
8.6
1.0
2.9
0.0
3.8
24.3
1.0
10.3
2.8
10.3
0
5
10
15
20
25
30
Composite
Mortality
Wound 
Infection
Pneumonia
Acute Renal 
Failure
Outcome Frequency, %
Figure 3.   Postoperative Complications
P=0.003
P=NS
P=0.05
P=0.10
P=0.24
Glargine+Glulisine
Sliding Scale Insulin
* Composite of hospital complications: wound infection, pneumonia, 
respiratory failure, acute renal failure, and bacteremia.


Glargine U300 vs U100_ Hospital Trial 
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In a recent preliminary study we assessed the efficacy of an HbA1c based algorithm for the management 
of non-ICU insulin treated patients with T2D (Fig. 4). A total 
of 214 general medicine and surgery patients with an 
admission HbA1c < 7% were discharged on their same 
outpatient antidiabetic regimen (oral antidiabetic drugs, 
OAD and/or insulin).  Patients with an HbA1c between 
7% and 9% were discharged on a combination of OADs 
and basal (glargine) insulin at 50% of total daily hospital 
dose. Patients with an admission HbA1c ≥ 9% were 
discharged on a combination of oral agents and basal 
insulin at 80-100% of total daily hospital dose or on a 
basal bolus regimen at the same hospital dosage. The admission HbA1c of 8.75% decreased to 7.9% and 
7.35% after 4 and 12 weeks of hospital discharge respectively (p<0.01, Fig 5).  Patients with higher 
HbA1c levels experienced a greater reduction as well as those treated with basal bolus insulin regimens. 
We concluded that the admission HbA1c concentration is beneficial in designing the discharge treatment 
algorithm after discharge in non-ICU patients with T2D. 
 
Our preliminary studies indicate that in general medicine and surgery patients with T2D 1) basal bolus or 
basal plus supplement regimens with glargine U100 are effective in improving glycemic control during 
the hospital stay, and 2) treatment with glargine U100 alone or in combination with oral agents or rapid-
acting insulin (basal bolus) is effective in improving and maintain glucose control after hospital discharge.  
In addition, these results indicate our ability to design, recruit and complete clinical trials in hospitalized 
patients with T2D.   
 
 
IV. 
EXPERIMENTAL PLAN 
 
Aim 1.  To determine differences in inpatient glycemic control, as measured by mean daily blood 
glucose concentration and frequency of hypoglycemia, in general medicine and surgery patients 
with T2D treated with basal bolus regimen with glargine U300 and U100 plus glulisine insulin 
before meals. 
 
IV.a. Rationale.   Several studies have shown improved clinical outcome with improved glycemic 
control in hospitalized patients with T2D (4, 5, 9, 11, 28, 37, 38). RCTs in medicine and surgical patients 
with T2D have shown that basal bolus regimen with glargine results in a lower mean daily BG 
concentration compared to the sole use of SSI and in lower rate of hospital complications (see preliminary 
results section). Glargine U300 results in similar improvement but in lower rate of hypoglycemia than 
treatment with glargine U100. No previous studies; however, have compared the efficacy and safety of 
glargine U300 in the management of hyperglycemia and diabetes in hospital setting.  Determining the 
safety and efficacy of new insulin formulations in the hospital, an environment associated with reduced 
insulin sensitivity and altered nutritional intake, is an exceedingly important clinical question.  
 
IV.b. STUDY DESIGN AND METHODS 
We will consent about 300 patients (for a total of 180 randomized subjects) with T2D treated with 
diet, oral hypoglycemic agents or insulin therapy, except long-acting GLP1-RA (albiglutide, albiglutide 
and weekly exenatide), prior to admission will be included in this prospective, randomized, open label 
trial to compare the safety and efficacy of a basal bolus regimen with glargine U300 and U100 in patients 
with T2D admitted to general medicine and surgery services. 
 
IV.c. Primary and Secondary Research Outcomes: 
6.5$
7$
7.5$
8$
8.5$
9$
HbA1c$
Admission$
4$weeks$
12$weeks$
8.75% 
7.9% 
7.35% 
% 
Change in HbA1C levels after discharge 
Umpierrez et al.  ADA Scientific Meeting, Philadelphia 2012 
HbA1c Concentration   
Fig 4 


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The primary outcome of the study is to determine differences in glycemic control as measured by mean 
daily blood glucose concentration between treatment groups. For each subject, we will take the average of 
all pre-meal and bedtime glucose values collected after the first day of therapy during the hospital stay (up 
to 10 days).   
 
Secondary outcomes include differences between treatment groups in any of the following measures:  
1. Differences in mean daily glucose in patients admitted to medicine and surgery services. 
2. Differences in mean daily glucose in patients with admission HbA1c lower than and higher than 8%. 
3. Differences in mean daily glucose in patients with length of stay shorter and longer than 3 and 5 days. 
4. Proportion of BG readings within target of 80 mg/dl and 180 mg/dl before meals. 
5. Number of BG readings between 80 mg/dl and 180 mg/dl before meals without hypoglycemia. 
6. Number of patients with hypoglycemia (defined as a BG < 70 mg/dl) and number of events adjusted by 
length of stay (event rate). 
7. Number of patients with severe hypoglycemia (defined as a BG < 40 mg/dl) and number of events 
adjusted by length of stay (event rate). 
8. Length of hospital stay. 
9. Cardiac complications are defined as myocardial infarction, cardiac arrhythmia requiring medical 
treatment, or cardiac arrest. 
10. Acute renal failure defined as a clinical diagnosis with documented new-onset abnormal renal function 
(increment in serum creatinine > 0.5 mg/dL from baseline). 
11. Hospital mortality.  
 
IV.d. Plan.  This study will include male or female subjects > 18 years. Due to the design of this study, 
there will be no run-in period.  Upon arrival to the emergency department or medical or general surgical 
wards, subjects will be screened.  Patients with a known history of T2D treated with diet alone, any 
combination of OADs, and insulin prior to admission will be considered potential candidates for this 
study. Patients treated with degludec, glargine U300 or with long-acting GLP1-RA (dulaglutide, 
albiglutide and weekly exenatide) prior to admission will be excluded. Patients admitted with acute or 
chronic medical illnesses, emergency or elective surgical procedures and trauma would be included in the 
study. The goal of insulin therapy is to maintain fasting and pre-meal blood glucose levels between 80 
mg/dl and 180 mg/dL while avoiding hypoglycemia.   
 
A total of 180 patients with T2D with a blood glucose > 140 mg/dL and < 400 mg/dL will be randomized 
to receive: 
 
Group 1.  Basal bolus with glargine U300 once daily and glulisine insulin before meals (n=90).  
Group 2.  Basal bolus with glargine U100 once daily and glulisine insulin before meals (n=90). 
 
IV.d. Basal Bolus Insulin Protocol.   
 
Patients will be treated with a basal bolus insulin regimen as previously reported (15, 16, 39).  In brief, 
subjects treated with insulin prior to admission will receive 80% of the total daily outpatient insulin dose 
given. Insulin naïve patients will discontinue oral agents and will receive a starting total daily dose (TDD) 
of 0.4 U/kg/day for BG between 140 mg/dl and 200 mg/dL and 0.5 U/kg/day for BG between 201 mg/dl 
and 400 mg/dL. The starting TDD will be reduced to 0.3 U/kg/day in patients ≥ 70 years or with a GFR < 
60 ml/min. Both groups will be treated with bolus regimen given half of TDD as basal (glargine U300 or 
U100) once daily and half as insulin glulisine divided in three equal doses before meals. Patients with 
poor oral intake or to be kept NPO will receive the basal dose, but prandial dose will be held (32). Insulin 
dose will be adjusted daily to maintain a fasting and pre-dinner BG between 80 mg/dl and 180 mg/dl. 
 


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IV. e Treatment randomization.  This is an open label randomized controlled trial.  Patients will be 
randomized 1:1 consecutively using a computer generated randomization table provided by Dr. Limin 
Peng, statistician at the Emory School of Public Health.  The randomization table will be mailed to the 
research pharmacist at each institution who will be in charge of the randomization and group assignment. 
A research pharmacist at each institution will follow a computer-generated block randomization table 
based on prior insulin use (yes/no). 
 
 
IV.f 
TREATMENT PROTOCOL - Basal Bolus Insulin Regimen with Glargine Once Daily plus 
Glulisine before Meals 
 
Patients Treated with Insulin Prior to Admission 
 Discontinue oral antidiabetic drugs on admission. 
Subjects treated with insulin prior to admission will receive 80% or 100% of the total daily dose 
(TDD) given as basal bolus regimen. Starting Insulin Doses: 
• 
Randomization BG <200mg/dl-give 80% of the TDD* 
• 
Randomization BG>200mg/dl-give 100% of the TDD* 
 Half of TDD will be given as basal (glargine U300 or U100) and half as rapid-acting insulin.   
 Glargine U300 and U100 will be given once daily, at the same time of the day.   
 Patients will receive the full-dose of glargine (even if NPO) the day of surgery or diagnostic 
procedure(s).     
 Glulisine insulin will be given in three equally divided doses before each meal.  To prevent 
hypoglycemia, if a subject is not able to eat, glulisine insulin dose will be held. 
* If patient was on basal only therapy consider adding prandial dose as calculated above.  
 
Insulin Naïve Patients Treated with Oral Agents or GLP1-RAs Prior to Admission 
 Discontinue oral antidiabetic drugs on admission. 
 Starting total daily insulin dose:  
 0.4 U/Kg/day when randomization BG between 140-200 mg/dL 
 0.5 U/Kg/day when randomization BG between 201-400 mg/dL   
 Reduce TDD to 0.3 units per kg in patients ≥ 70 years of age and/or with an eGFR < 60 
ml/min. 
 Half of TDD will be given as glargine U300 or U100 and half as glulisine.   
 Glargine will be given once daily, at the same time of the day.   
 Patients will receive the full-dose of glargine insulin (even if NPO) the day of surgery or 
diagnostic procedure(s).     
 Glulisine insulin will be given in three equally divided doses before meals. To prevent 
hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.  
 
Supplemental insulin. Glulisine insulin will be administered following the “supplemental/correction 
insulin scale” protocol (Appendix 1).   
 If a patient is able and expected to eat most of his/her meals, supplemental insulin will be 
administered before meals and at bedtime following the “usual” dose of the insulin scale protocol. 
 If a patient is not able to eat, supplemental insulin will be administered every 6 hours following 
the “sensitive” dose of the supplemental insulin scale protocol. 
 
Basal Insulin adjustment.   
 Daily basal (glargine U300 and U100) insulin dose will be adjusted as follow:  


Glargine U300 vs U100_ Hospital Trial 
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9
 If the fasting and pre-dinner BG is between 100 - 140 mg/dl in the absence of hypoglycemia 
the previous day: no change  
 If the fasting and pre-dinner BG is between 141 - 180 mg/dl in the absence of hypoglycemia: 
increase basal insulin by 10% every day  
 If the fasting and pre-dinner BG is 181- 299 mg/dl in the absence of hypoglycemia the 
previous day: increase basal insulin (glargine) dose by 20% every day  
 If the fasting and/or pre-dinner BG is ≥ 300 mg/dl in the absence of hypoglycemia the previous 
day: increase basal insulin (glargine) dose by 30% every day 
 If the fasting and pre-dinner BG is between 70 - 99 mg/dl in the absence of hypoglycemia: 
decrease TDD (basal and prandial) insulin dose by 10% every day  
 If a patient develops hypoglycemia (BG <70 mg/dL), the insulin TDD (basal and prandial) 
should be decreased by 20%.   
 If a patient develops severe hypoglycemia (BG <40 mg/dL), the insulin TDD (basal and 
prandial) should be decreased by 30-40%.   
 
IV.g. 
Data Analysis: 
Aim 1.  To determine differences in inpatient glycemic control, as measured by mean daily blood 
glucose concentration and frequency of hypoglycemia, in general medicine and surgery patients 
with T2D treated with basal bolus regimen with glargine U300 and U100 plus glulisine insulin 
before meals. 
 
Due to the lack of efficacy and safety data with the use of glargine U300 in the inpatient setting, periodic 
conduct interim analyses will be conducted every 6 months to monitor the primary outcome and rate of 
hypoglycemia, and to modify the study design regarding interval of administration and dosage adjustment 
for basal insulin (see page 9, Data Safety Monitoring Plan, sections IV. f. and IV.g.).       
 
Sample Size and Power Calculations:  
The primary endpoint in this study is glycemic control measured by mean daily BG concentration.  To 
show the non-inferiority of glargine U300 and U100 in terms of glycemic control, we set the equivalence 
margin as 18 mg/dl (1 mosm/l), from a view that a difference <18 mg/dl is usually not considered as 
clinically significant (12, 14, 16). Based on the results from Rabbit medicine and surgery trials, it is 
reasonable to assume the standard deviation of mean daily BG is bounded above by 45 mg/dl. Assuming 
the true BG difference between the treatment groups is zero, and using one-sided, two-sample t-tests, we 
require 78 subjects for each treatment group to achieve 80% power. Accounting for 10% attrition rate, we 
would need 90 patients per treatment group, which means 180 subjects in total, to achieve >80% power in 
Aim 1.  
 
Analysis of Primary Endpoint: 
The primary endpoint for Aim 1 is glycemic control measured by mean daily BG concentration among the 
two study groups. Blood glucose will be measured before each meal and at bedtime.  We will first 
perform cross-sectional analyses using nonparametric Krustal-Wallis tests (or Wilcoxon tests) or one-way 
ANOVA, followed by repeated measures ANOVA to estimate and test the difference between the two 
treatment groups while simultaneously examining mean daily BG across multiple days during treatment. 
A mixed effect model may be used to further account center effect or other potential confounders for the 
BG outcome. Stepwise, backward, or forward model selection strategy will be adopted to determine the 
variables to be included in the final model. Standard diagnostic and model checking procedures will be 
applied to examine the fit of the developed models. 
 
Analysis of Secondary Endpoints: 
Secondary endpoints for Aim 1in this study include incidence of hypoglycemia, number of hypoglycemic 


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events, number of severe hyperglycemia, mean daily fasting BG, daily insulin dose, length of hospital 
stay, acute renal failure and hospital mortality. Blood glucose will be measured before each meal and at 
bedtime.  For discrete outcomes (such as hypoglycemia outcomes), if the outcome is binary (e.g. with or 
without hypoglycemia), we will first conduct nonparametric comparisons based on a two-sided Chi-
square test (or Fisher’s exact test in the presence of low incidence rates), followed by the Cochran-
Mantel-Haenszel test, which adjusts for the potential center effect. If the discrete outcome is a count 
outcome (such as the number of hypoglycemic event), we will perform Poisson regression (or Negative 
Binomial regression) that adjusts for the length of hospital stay to assess the difference in the count 
outcome between the treatment groups. We also value the repeated measures analyses based on mixed 
effect models. This is because they will allow us to assess treatment effect fined tuned according to other 
confounders of the BG outcomes. By these considerations, we will conduct both types of analyses to 
provide a thorough evaluation of the hypothesis of interest. For continuous outcomes that are not repeated 
measures (such as length of hospital stay), we will use two-sample t-tests or nonparametric Wilcoxon 
tests to compare them between groups. Transformations will be applied if normality violation is detected.  
Multivariate linear regression will be further conducted to assess the difference in continuous secondary 
outcomes between the two groups while other relevant covariates. We will use standard model selection 
and model checking procedures for linear regression to decide the final models and assess their fits to the 
data. 
 
IV.f.        Data and Safety Monitoring Board (DSMB): 
The Data and Safety Monitoring Board (DSMB) will review unblended data on safety, treatment 
compliance, and evaluate the efficacy of the intervention being studied in this clinical trial. The DSMB 
will meet at 6-month intervals and report on study progress to the IRB.  
IV.g. Interim Analysis and Stopping Rules:  We plan to perform one interim analysis on the primary 
endpoint every 6 months and when half of the subjects have been randomized. The trial will be stopped if 
there is evidence beyond a reasonable doubt of a difference in the rate of death and hospital complications 
(two-sided alpha level, <0.01) between the treatment groups.  
 
 
 
V. 
Aim 2:  To determine differences in glycemic control after hospital discharge between 
treatment with glargine U300 and glargine U100 in medicine and surgery patients T2D.   
 
V.a. 
Rationale.  Few studies have addressed the efficacy of insulin alone or in combination with oral 
agents after hospital discharge. In a recent study (see preliminary results section), patients were 
discharged on a combination of OADs and glargine U100 insulin or on a basal bolus regimen according to 
bA1c levels and achieved a marked reduction in HbA1c from 8.75% on admission to 7.9% and 7.35% 
after 4 and 12 weeks of hospital discharge. However, the use of glargine U100 alone or in combination to 
oral agents or as basal bolus insulin resulted in 30% and close to 40% incidence of hypoglycemia, 
respectively. In this study, we will compare the efficacy and safety of glargine U300 and U100 after 
hospital discharge. The total duration of the study is 3 months. Several outpatient insulin trials have 
shown that treatment with glargine U300 results in similar improvement in glycemic control, but in 
significant reduction in hypoglycemia compared to glargine U100 (23-27). Thus we expect that glargine 
U300 will be a safer alternative to current use of glargine U100 formulation. 
  
 V.b Insulin Discharge algorithm:  
Patients with poorly controlled diabetes (HbA1c ≥7.5%) enrolled in Aim 1 will be invited to participate in 
this open label prospective outpatient study. The total duration of the study is 3 months.  


Glargine U300 vs U100_ Hospital Trial 
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11
 Patients with admission Hba1c < 7.5% will be discharged on their preadmission antidiabetic 
regimen and will not be included in the Aim 2 outpatient study.  
 Patients with no previous pharmacological treatment prior to admission will be discharged on 50% 
of daily basal insulin (glargine U300 or glargine U100) hospital dose. 
 Patients on oral agents prior to admission with an HbA1c between 7.5% and <10% will be 
discharged on oral agents plus glargine U300 or glargine U100 at 50% of the daily hospital dose.  
 Patients on oral agents prior to admission with an admission A1C ≥ 10% will be discharged on 
their oral agents plus glargine U300 or glargine U100 at 80% of daily hospital dose.  If previous 
basal bolus only therapy or contraindications to previous oral therapy, discharge on basal bolus at 
100% of daily hospital dose. 
 Patients on oral agents plus basal insulin (NPH, glargine, detemir) prior to admission with HbA1C 
between 7.5% and <10% will be discharged on their oral agents plus glargine U300 or glargine 
U100 at 50% of daily hospital dose.   
 Patients on oral agents plus basal insulin (NPH, glargine, detemir) prior to admission with an 
admission A1C ≥ 10% will be discharged on their oral agents plus glargine U300 or glargine U100 
at 80% of daily hospital dose.  If contraindications to previous oral therapy, discharge on basal 
bolus at 100% of daily hospital dose. 
Patients treated with basal or basal bolus regimen prior to admission will be discharged on 50%-80% of 
their preadmission TDD with glargine once daily and glulisine before meals.   
 
 
Concomitant Medications: 
Background medications: 
 
Metformin.   Metformin is considered background medication (non-investigational medicinal product) 
and will not be provided during the trial.  The total daily dose of metformin prior to admission will be 
restarted at hospital discharge with no dose adjustments occurring during the trial. Patients with eGFR 
between 30-45 ml/min will be discharged at a max-dose of 500 mg twice daily.  Patients with eGFR < 30 
ml/min will not be allowed to receive metformin.   


Glargine U300 vs U100_ Hospital Trial 
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12
 
Sulfonylurea and Insulin secretagogues.  Sulfonylurea treatment is considered background medication 
(non-investigational medicinal product) and will not be provided during the trial.  The total daily dose of 
sulfonylurea prior to admission will be reduced by 50% or stopped at hospital discharge at the 
investigator’s discretion.    
 
Pioglitazone.  Pioglitazone is considered background medication (non-investigational medicinal product) 
and will not be provided during the trial. The total daily dose of pioglitazone prior to admission will be 
restarted at hospital discharge.  No dose adjustment or up-titration will occur during the trial; however, in 
the event of peripheral edema or signs of volume overload, the dose of pioglitazone can be reduced or 
stopped at the investigator’s discretion.    
 
DPP4-inhibitors.  DPP4-i treatment is considered background medication (non-investigational medicinal 
product) and will not be provided during the trial.  The total daily dose of DPP4-I will be adjusted as per 
renal function (eGFR). No dose adjustment or up-titration will occur during the trial. 
 
GLP1-RA.  GLP1-RA treatment is considered background medication (non-investigational medicinal 
product) and will not be provided during the trial.  No dose adjustment or up-titration will occur during 
the trial. 
 
SGLT2-i.  The use of SGLT2-I is considered background medication (non-investigational medicinal 
product) and will not be provided during the trial.  No dose adjustment or up-titration will occur during 
the trial. 
 
 
V.c. Hospital Diabetes Education.  Prior to discharge, participants will be trained in: 
1. Diabetes education if not received within 1 year of admission   
2. Recommended targets for fasting and premeal blood glucose between 90 to 130 mg/dL 
3. Use of glucose meters for home glucose self-monitoring 
4. Keeping BG records, and will receive a logbook to record glucose tests results. 
5. Hypoglycemia prevention, recognition and management 
6. Insulin administration 
 
V.d. 
Follow-up Care: 
 Provide glargine insulin 1-month supply at each clinic visit.  
 A member of the diabetes research team will contact patients via telephone call every 2 weeks for 
a total of 3 months.   
 Patients will be asked to attend outpatient visits at 1 and 3 month after hospital discharge.   
 Recommendation on insulin adjustment to be provided after each telephone contact and/or clinic 
visit by a licensed physician (fellow or study physician) (section V.f).     
 
V.e. 
During follow up we will collect the following information:   
1. Glycemic control: 
a. Mean daily fasting and premeal blood glucose levels 
b. HbA1C at 1 and 3 months after hospital discharge 
c. Hypoglycemic events (BG < 70 mg/dl and < 40 mg/dl) 
d. Hyperglycemic events (BG > 240 mg/dl) 
2. Diabetes treatment: 
a. Insulin dosage (unit/day) 
b. Use of oral agents 


Glargine U300 vs U100_ Hospital Trial 
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13
c. Protocol adherence  
3. Clinical Outcome: 
a. Hospital readmissions 
b. Emergency room visits 
c. Postoperative complications 
 
V.f.    Primary care physicians will be provided with the following algorithm for outpatient basal 
insulin dose adjustment every 2 weeks: 
 
Basal Insulin (glargine U300 and glargine U100) 
If mean FBG > 180 mg/dL for the last 
3 consecutive days and no hypoglycemia or no 
random BG (RBG) <70 mg/dL 
Increase daily dose by 4 IU 
If mean FBG > 140 mg/dL for the last 
3 consecutive days and no hypoglycemia < or 
no RBG <70 mg/dL 
Increase daily dose by 2 IU 
If mean FBG between 100 - 140 mg/dL and 
no hypoglycemia or no RBG <70 mg/dL 
No Change 
If any FBG between 70 – 99 mg/dl 
Decrease by 4 IU or 10% of total daily dose 
If any FBG or RBG 40- 69 mg/dl 
Decrease by 8 IU or 20% of total daily dose 
If any FBG or RBG < 40 mg/dl 
Decrease total daily dose by 30 - 40% 
 
V.g.  Aim 2. Statistical Analysis: 
V.g.1. Sample Size and Power Calculations: The primary endpoint in Aim 2 is difference in glycemic 
control (mean daily BG) after hospital discharge. Under the same assumptions for equivalence margin and 
BG variability as in Aim 1, we have the same sample size requirement (i.e. 78 subjects per group after 
10% attrition). Accounting for 10% attrition rate, we would need 90 patients per treatment group (total # 
of patients to be recruited: 180 subjects, 90 per treatment group), to achieve >80% power.  
 
V.g.2. Analysis of Primary Endpoint: 
The primary endpoint in this study is glycemic control measured by mean daily BG concentration after 
hospital discharge. Secondary outcomes include rate of hypoglycemia during follow-up, change in 
HbA1c, body weight in kilograms, number of episodes of severe hyperglycemia, complications and 
emergency room visits or hospital readmissions at 12 weeks post-discharge. To analyze these outcomes, 
we will follow the same analytic strategy proposed for the secondary endpoints of Aim 1. We will first 
compare the primary outcome using two-sample t-tests (or Wilcoxon tests) or one-way ANOVA, 
followed by multivariate linear regression to estimate and test the difference between the two treatment 
groups while simultaneously accounting for other potential confounders. Transformations will be applied 
if normality violation is detected. Stepwise, backward, or forward model selection strategy will be 
adopted to determine the variables to be included in the final model. Standard diagnostic and model 
checking procedures will be applied to examine the fit of the developed models. 
 
DATA HANDLING AND RECORD KEEPING: 
Data collection records with personal identifiers will be stored in locked file cabinets.  Presentation of the 
study results at regional or scientific meetings or in publications will not identify subjects.  Access to 
research and confidential records will be limited to clinical investigators, research coordinators, and the 
IRB at Emory University.  
All data will be entered electronically in Redcap by participating sites. Sponsor site expects data to be 
entered in Redcap within 10 days of phone call or outpatient visit. 


Glargine U300 vs U100_ Hospital Trial 
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14
 
VI. 
Methods and Procedures Applied to Human Subjects: 
 
VI.a. Subject Population: 
 
We plan to study a total of 180 randomized patients with a known history of T2D, age > 18 years, 
treated with diet alone, any combination of oral antidiabetic agents, GLP1-RA (except long-acting agents: 
albiglutide, albiglutide and weekly exenatide) or insulin therapy (except degludec or glargine U300).  
Patients included within this study will be determined by the set of inclusion and exclusion criteria. 
 
VI.b. Inclusion Criteria: 
1. 
Males or females between > 18 years admitted to a general medicine or surgical service.   
2. 
Known histories of T2D treated with either diet alone, oral monotherapy, any combination of oral 
antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy with the 
exception of degludec and glargine U300.  
3. 
Subjects must have a randomization BG > 140 mg and < 400 mg/dL without laboratory evidence 
of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive serum or urinary 
ketones). 
 
VI.c. Exclusion Criteria:  
1. 
Subjects with increased BG concentration, but without a known history of diabetes. 
2. 
Admission or pre-randomization BG≥400 mg/dl 
3. 
Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA (weekly 
exenatide, dulaglutide or albiglutide).  
4. 
Patients with acute critical or surgical illness admitted to the ICU or expected to require admission 
to the ICU. 
5. 
Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), 
corticosteroid therapy, or impaired renal function (eGFR< 30 ml/min). 
6. 
Mental condition rendering the subject unable to understand the nature, scope, and possible 
consequences of the study. 
7. 
Female subjects who are pregnant or breast-feeding at time of enrollment into the study. 
 
VI.d. Withdrawal Criteria 
1. The subject may withdraw at will at any time. 
2. The subject may be withdrawn from the trial at the discretion of the investigator due to a safety concern 
or if judged non-compliant with trial procedures or included in contravention to the inclusion and/or 
exclusion criteria. 
3. Subject admitted to the ICU who required continuous intravenous insulin infusion to maintain glycemic 
control. 
4. Pregnancy or intention to become pregnant.  
5. Treatment with oral or injectable corticosteroid (equivalent or higher than prednisone 5mg/day), 
parenteral nutrition and immunosuppressive treatment after randomization. 
 
Treatment Failure Criteria 
Subjects with persistent hyperglycemia (≥ 2 glucose readings ≥ 400 mg/dL, ≥ 3 consecutive glucose 
readings > 280 mg/dL, or with a mean daily blood glucose concentration ≥ 280 mg/dL) and no treatable 
intercurrent cause for the hyperglycemia has been identified, will be considered as treatment failure and 
discontinued from the study.  If needed, subjects will be started on continuous insulin infusion.   
 


Glargine U300 vs U100_ Hospital Trial 
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15
VII. 
Study Sites:  This study will be performed at Grady Memorial Hospital, Emory University 
Hospitals, Atlanta, GA, Minneapolis Medical Research Foundation-Hennepin Medical Center, 
Minneapolis, and The Cleveland Clinic Foundation, Ohio. 
 
 
 
 
 
 
VIII. CLINICAL MANAGEMENT GUIDELINES 
 
 
VIII.a.  Admission Laboratory Studies 
 
 
Standard of care laboratory studies including glucose, HbA1C, and chemistry will be measured on 
admission and as determined by the treating physician.   
For research purposes a blood sample will be obtained to measure HbA1C at 1 month and 3 months 
after discharge.  In addition, a urine pregnancy test will be performed, when clinically indicated prior to 
randomization (in female subjects of child bearing potential only).   
 
VIII.b.    Assessment and Monitoring of Hospital Mortality  
The investigators and research team will follow study subjects daily and the presumed cause of death will 
be recorded.  Information on the attending physician’s summary of events surrounding subject’s demise 
will also be documented.    
VIII.c. Assessment and Monitoring of Nosocomial Infections  
Nosocomial infections will be diagnosed based on standardized CDC criteria (40).  New nosocomial 
infections will not be diagnosed until 48 hours after study initiation to minimize the chance that the 
infection was actually present (but undiagnosed) prior to study initiation.   
The investigators will review each subject’s records regarding potential new infection diagnosis daily on 
each weekday from Monday to Friday. Data from the weekends will be collected on the following 
Monday.  The coded infection diagnosis and the presumed causative microorganism will be determined 
daily on a Monday to Friday basis, with weekend data entered on the following Monday.   
 
Aim 1.  Inpatient Arm – Flow Chart 
 
Visit Type 
Hosp-
Day 1 
Hosp-
Day 2 
Hosp-
Day 3 
Hosp-
Day 4 
Hosp-
Day 5 
Hosp-
Day 6 
Hosp-
Day 7 
Hosp-
Day 8 
Hosp-
Day 9 
Hosp-
Day 10 
Visit # 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Time-days 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
Inf. consent  
x 
 
 
 
 
 
 
 
 
 
Inclusion/excl criteria 
x 
 
 
 
 
 
 
 
 
 
Randomization 
x 
 
 
 
 
 
 
 
 
 
Withdrawal criteria 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Dose adjustment 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Efficacy 
 
 
 
 
 
 
 
 
 
 
Vital signs1 
x 
 
 
 
 
 
 
 
 
x 
Phys Exam1 
x 
 
 
 
 
 
 
 
 
x 
Body weight 
x 
 
 
 
 
 
 
 
 
x 
BMI 
x 
 
 
 
 
 
 
 
 
x 
HbA1c 
x 
 
 
 
 
 
 
 
 
 
Fasting BG 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Pre-meal BG 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Safety 
 
 
 
 
 
 
 
 
 
 


Glargine U300 vs U100_ Hospital Trial 
01/28/2019 
 
 
16
Adv events 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Hypoglycemia 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Urine pregnancy test 
x 
 
 
 
 
 
 
 
 
x 
Trial material 
 
 
 
 
 
 
 
 
 
 
Drug dispense2 
x 
 
 
 
 
 
 
 
 
 
1At time of study enrollment and hospital discharge 2As needed 
 
 
 
 
Flow Chart:  Aim 2, Outpatient Study 
 
Visit Type 
Hospital 
Day 1 
TC 
Clinic 
visit 
TC 
TC 
TC 
Clinic 
visit 
Visit # 
1 
2 
3 
4 
5 
6 
7 
Time-wks 
0 
2 
4 
6 
8 
10 
12 
Inf. consent  
x 
 
 
 
 
 
 
Incl/excl criteria 
x 
 
 
 
 
 
 
Randomization 
x 
 
 
 
 
 
 
Withdrawal criteria 
 
x 
x 
x 
x 
x 
x 
Drug Compliance 
 
x 
x 
x 
x 
x 
x 
Dose adjustment 
 
x 
x 
x 
x 
x 
x 
Efficacy 
 
 
 
 
 
 
 
Vital signs 
x 
 
x 
 
 
 
x 
Phys Exam 
x 
 
x 
 
 
 
x 
Body wgt 
x 
 
x 
 
 
 
x 
BMI 
x 
 
x 
 
 
 
x 
HbA1c 
x 
 
x 
 
 
 
x 
Fasting BG 
x 
 
x 
 
 
 
x 
Safety 
 
 
 
 
 
 
 
Adv events 
x 
x 
x 
x 
x 
x 
x 
Hypoglycemia 
x 
x 
x 
x 
x 
x 
x 
Urine pregnancy test 
x 
 
x 
 
 
 
 
CMP or BMP 
x 
 
x 
 
 
 
x 
Trial material 
 
 
 
 
 
 
 
Drug dispense 
x 
 
x 
 
 
 
 
Drug account 
x 
 
x 
 
 
 
x 
 
IX. 
Potential Risks to the Subject: 
IX.a. Hypoglycemia.   It is possible that following the proposed protocol, patients receiving insulin 
glargine U300 and U100 may develop hypoglycemia. The risk of hypoglycemia in non-ICU patients 
treated with subcutaneous insulin is between 5–30% (12, 17, 41, 42). The number of hypoglycemia will 
be analyzed statistically. For the purpose of this analysis, hypoglycemia is defined as a BG < 70 mg/dL. 
Severe hypoglycemia is defined as BG < 40 mg/dL. 
 
X. 
Protection against risks: 
 
We will follow safeguards to minimize the risk to our subjects: a) we will carefully monitor capillary BG 
at the bedside using a hand-held glucose meter, b) only experienced nurses/or phlebotomist will draw 
blood samples, and c) women of reproductive age who are sexually active will undergo a urine pregnancy 
tests prior to participation in the study.  To prevent significant clinical events, no patients with history of 
significant liver, renal impairment or cardiac failure will be recruited in this study.    
 
X.a. 
Hypoglycemia:  We expect that approximately 10% in the inpatient setting and ~20% in the 
outpatient (post-discharge) arm will experience one or more episodes of hypoglycemia.  To minimize the 
risk of hypoglycemia, the starting dose will be reduced in the basal bolus insulin regimen (TDD: 0.3 units 


Glargine U300 vs U100_ Hospital Trial 
01/28/2019 
 
 
17
per kg of body weight) in patients ≥ 70 years of age and/or eGFR < 60 ml/min.  To avoid hypoglycemia, 
the total daily dose of insulin will be decreased by 10% for BG between 70-99 mg/dl and by 20% after 
each episode of hypoglycemia (BG < 70 mg/dl).  In addition, in patients treated with insulin at home, the 
TDD of insulin will be reduced by 20% on admission and the attending physician may further reduce 
insulin dose in the presence of severe hypoglycemia. 
 
Hypoglycemia will be treated with dextrose infusion.  Dextrose 50% solution will be given for glucose 
values < 70 mg/dl.  If the patient is awake, 25 ml (1/2 amp) will be given IV or oral juice/snack (crackers) 
as per protocol.  If the patient is not awake:  50ml (1 amp) will be given STAT.  Blood glucose levels will 
be repeated in 15 minutes and dextrose administration will be repeated as needed for values < 70 mg/dl.   
 
XI. 
Inclusion of women. 
We anticipate that ~50% of the study subjects will be female.  Absence of pregnancy must be 
demonstrated by blood or urine testing prior to randomization (in female subjects of child bearing 
potential only).  Glargine U300 and U100 have not been approved during pregnancy.   
 
XII. 
Inclusion of minorities. 
Patients will not be excluded based on race or ethnic origin.  We anticipate that approximately 
one-third of patients will be African Americans, Hispanics, and Caucasians.   
 
XIII. Inclusion of children. 
No patients under the age of 18 will be recruited in this study. 
 
XIV.   Payment for participation.     
Participation in this study is voluntary.  Patients will receive one hundred dollars ($100.00) during 
the hospital stay.  If a participant should stop participation before completion, the payment will be 
prorated at $10.00 per day. Participants will receive seventy- five dollars ($75.00) after each clinic visit at 
1 and 3 months after discharge. Total compensation will be two hundred and fifty dollars ($250.00). 
 
 
XV.   Financial conflict of interests. 
 
This study receives support from Sanofi. Dr. Umpierrez serves as a consultant to Sanofi and 
receives compensation for these services. The terms of this arrangement have been reviewed and 
approved by Emory University in accordance with its conflict of interest policies. 
 
 
XVI.    Pharmacovigilance specifications 
 
1. 
DEFINITIONS 
Serious adverse event (SAE): any untoward medical occurrence that at any dose:  
 Results in death, 
 Is life threatening, (Note: the term “life-threatening” refers to an event/reaction in which the patient 
was at risk of death at the time of the event/reaction; it does not refer to an event/ reaction which 
hypothetically might have caused death if it were more severe), 
 Requires inpatient hospitalization or results in prolongation of existing hospitalization, 
 Results in persistent or significant disability/incapacity, 
 Is a congenital anomaly/birth defect, or 


Glargine U300 vs U100_ Hospital Trial 
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18
 Is a medically important event or reaction. Medical and scientific judgment should be exercised in 
deciding whether other situations should be considered serious, such as important medical events 
that might not be immediately life-threatening or result in death or hospitalization, but might 
jeopardize the patient or might require intervention to prevent one of the other outcomes listed in 
the definition above. 
Related Adverse Event, i.e. Adverse Drug Reaction (ADR): There is a reasonable possibility according to 
the ISS sponsor that the product may have caused the event. 
 
Unexpected Adverse Event, i.e. Adverse Drug Reaction (ADR): An adverse reaction, the nature or severity 
of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an 
unapproved investigational medicinal product or package insert/summary of product characteristics for an 
approved product). An expected ADR with a fatal outcome should be considered unexpected unless the 
local/regional product labelling specifically states that the ADR might be associated with a fatal outcome. 
 
Adverse Event of Special Interest (AESI): An adverse event of special interest (AESI) is an adverse event 
(serious or non-serious) of scientific and medical concern specific to the Sponsor’s product or program, for 
which ongoing monitoring and rapid communication by the Investigator to the Sponsor may be appropriate. 
Such events may require further investigation in order to characterize and understand them. AESIs may be 
added or removed during a study by protocol amendment. 
 
New safety finding : Any (other than reportable individual case safety report (ICSR)) safety issue that may 
require expedited reporting because providing information that may lead to a change in the known risk-
benefit balance for the  product and as mentioned, but not limited to, in the following regulatory texts: 
Europe: Volume 9A of the Rules Governing Medicinal products in the European Union (September 2008) 
Section 4.1; and US: FDA: 21 CFR Parts 312 Investigational New Drug Application- Section 312.32, (c) 
(1) IND safety reports. 
 
2. 
OBLIGATIONS AND RESPONSIBILITIES OF THE ISS SPONSOR 
 The ISS sponsor warrants that the study will be performed in compliance with all applicable local 
and international laws and regulations, including without limitation ICH E6 guidelines for Good 
Clinical Practices.  
 The ISS sponsor shall be responsible for the respect of all obligations required by applicable local 
and international laws and regulations.  
 The sponsor shall be responsible for ensuring submission of required expedited and periodic reports 
to the appropriate Regulatory Authority (RA), the Ethics Committee and investigators of each 
country participating in the ISS (based on applicable regulations).  
 Any Periodic reports (e.g. Development Safety Update Report (DSUR)), submitted to Regulatory 
Authority must first be transmitted to Sanofi for review and comment. 
 The study reports of any ISS must contain a section describing safety review and conclusion and 
must be reviewed by Sanofi before finalization. 
 New Safety Findings in a study pertaining to safety of product must be transmitted within 1 business 
day. (e.g., Data Safety Monitoring Board recommendations) 
The ISS sponsor must provide to Sanofi upon request results of any relevant complementary exams 
performed to obtain the final diagnosis of any SAE (e.g., hospital discharge summary, autopsy, 
consultation). 
 The Institution must report the following information in English to the Sanofi group entity 
Pharmacovigilance contact: 


Glargine U300 vs U100_ Hospital Trial 
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19
 Routine transmission of all Serious Adverse Events (SAEs) including pregnancy, overdose and 
Adverse Events of Special Interest (AESI), if any. These events must be transmitted within 1 
business day of the Institution’s awareness or identification of the event. 
 Routine transmission of SAEs related to the use of the Sanofi product must be transmitted within 
1 business day of the Institution’s awareness or identification of the event. The reference safety 
information to be used by the Institution for evaluation of expectedness of adverse events shall 
be the current approved product label available in the country for an approved indication or the 
Investigator Brochure for an unapproved indication. 
 Any Periodic reports (e.g. Development Safety Update Report (DSUR)), submitted to 
Regulatory Authority must be transmitted to Sanofi at the time of submission. 
 New Safety Findings in a study pertaining to safety of product must be transmitted within 1 
business day. (e.g., Data Safety Monitoring Board recommendations) 
 The study reports of any ISS must contain a section describing safety review and conclusion and 
must be reviewed by Sanofi before finalization. 
 
 The reference safety information to be used by the ISS sponsor for evaluation of expectedness of adverse 
events shall be the current approved product label available in the country (for an approved indication) 
 
3. 
SANOFI GROUP ENTITY PHARMACOVIGILANCE CONTACT 
 
 
These reports may be sent by GPE-PV E-MAIL to:  
Reports by E-MAIL should be sent to: CL-CPV-Receipt@sanofi.com or Fax: 908-547-8000, 
within 24 hours of receipt by investigator/sponsor. E-Mail or Fax transmission should include 
the following:  
Investigator-Sponsored (IST #) study number: SA-2016-11517  
Study Title: _ Glargine U300 Hospital Trial: A Randomized Controlled Trial Comparing 
Glargine U300 and Glargine U100 for the Inpatient and Post-Hospital Discharge Management of 
Medicine and Surgery Patients with Type 2 Diabetes  
Name of Principal Investigator: Guillermo Umpierrez, MD, CDE. 
 


Glargine U300 vs U100_ Hospital Trial 
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XVI. References 
1. 
Umpierrez GE, Isaacs SD, Bazargan N, You X, Thaler LM, Kitabchi AE. Hyperglycemia: an 
independent marker of in-hospital mortality in patients with undiagnosed diabetes. J Clin 
Endocrinol Metab. 2002;87(3):978-82. 
2. 
Finney SJ, Zekveld C, Elia A, Evans TW. Glucose control and mortality in critically ill patients. 
Jama. 2003;290(15):2041-7. 
3. 
Van den Berghe G, Wouters PJ, Bouillon R, Weekers F, Verwaest C, Schetz M, et al. Outcome 
benefit of intensive insulin therapy in the critically ill: Insulin dose versus glycemic control. Crit 
Care Med. 2003;31(2):359-66. 
4. 
Pomposelli JJ, Baxter JK, 3rd, Babineau TJ, Pomfret EA, Driscoll DF, Forse RA, et al. Early 
postoperative glucose control predicts nosocomial infection rate in diabetic patients. JPEN J 
Parenter Enteral Nutr. 1998;22(2):77-81. 
5. 
Malmberg K, Ryden L, Efendic S, Herlitz J, Nicol P, Waldenstrom A, et al. Randomized trial of 
insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute 
myocardial infarction (DIGAMI study): effects on mortality at 1 year. J Am Coll Cardiol. 
1995;26(1):57-65. 
6. 
Clement S, Braithwaite SS, Magee MF, Ahmann A, Smith EP, Schafer RG, et al. Management of 
diabetes and hyperglycemia in hospitals. Diabetes Care. 2004;27(2):553-97. 
7. 
McAlister FA, Majumdar SR, Blitz S, Rowe BH, Romney J, Marrie TJ. The relation between 
hyperglycemia and outcomes in 2,471 patients admitted to the hospital with community-acquired 
pneumonia. Diabetes Care. 2005;28(4):810-5. 
8. 
Baker EH, Janaway CH, Philips BJ, Brennan AL, Baines DL, Wood DM, et al. Hyperglycaemia is 
associated with poor outcomes in patients admitted to hospital with acute exacerbations of chronic 
obstructive pulmonary disease. Thorax. 2006;61(4):284-9. 
9. 
Furnary AP, Gao G, Grunkemeier GL, Wu Y, Zerr KJ, Bookin SO, et al. Continuous insulin 
infusion reduces mortality in patients with diabetes undergoing coronary artery bypass grafting. J 
Thorac Cardiovasc Surg. 2003;125(5):1007-21. 
10. 
Van den Berghe G, Wilmer A, Hermans G, Meersseman W, Wouters PJ, Milants I, et al. Intensive 
insulin therapy in the medical ICU. N Engl J Med. 2006;354(5):449-61. 
11. 
van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, et al. Intensive 
insulin therapy in the critically ill patients. N Engl J Med. 2001;345(19):1359-67. 
12. 
Umpierrez GE, Hor T, Smiley D, Temponi A, Umpierrez D, Ceron M, et al. Comparison of 
inpatient insulin regimens with detemir plus aspart versus neutral protamine hagedorn plus regular 
in medical patients with type 2 diabetes. J Clin Endocrinol Metab. 2009;94(2):564-9. 
13. 
Umpierrez GE, Palacio A, Smiley D. Sliding scale insulin use: myth or insanity? Am J Med. 
2007;120(7):563-7. 
14. 
Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, et al. RAndomized Study of 
Basal Bolus Insulin Therapy in the Inpatient Management of Patients with Type 2 Diabetes 
Undergoing General Surgery (RABBIT Surgery). Diabetes Care. 2011;34(2):256-61. 
15. 
Umpierrez GE, Simley D, Jacobs S, Peng L, Temponi A, Mulligan P, et al. RAndomized Study of 
Basal Bolus Insulin Therapy in the Inpatient Management of Patients with Type 2 Diabetes 
Undergoing General Surgery (RABBIT Surgery). Diabetes Care. 2011;34(2):256-61. 
16. 
Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, et al. Randomized study of 
basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 
2 trial). Diabetes Care. 2007;30(9):2181-6. 
17. 
Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, et al. Randomized study of 
basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes 
undergoing general surgery (RABBIT 2 surgery). Diabetes Care. 2011;34(2):256-61. 


Glargine U300 vs U100_ Hospital Trial 
01/28/2019 
 
 
21
18. 
Moghissi ES, Korytkowski MT, DiNardo M, Einhorn D, Hellman R, Hirsch IB, et al. American 
Association of Clinical Endocrinologists and American Diabetes Association consensus statement 
on inpatient glycemic control. Diabetes Care. 2009;32(6):1119-31. 
19. 
Umpierrez GE, Hellman R, Korytkowski MT, Kosiborod M, Maynard GA, Montori VM, et al. 
Management of hyperglycemia in hospitalized patients in non-critical care setting: an endocrine 
society clinical practice guideline. J Clin Endocrinol Metab. 2012;97(1):16-38. 
20. 
Standards of medical care in diabetes--2012. Diabetes Care. 2012;35 Suppl 1:S11-63. 
21. 
Monnier L, Owens DR, Bolli GB. The new long-acting insulin glargine U300 achieves an early 
steady state with low risk of accumulation. Diabetes Metab. 2015. 
22. 
Goldman J, White JR, Jr. New Insulin Glargine 300 U/mL for the Treatment of Type 1 and Type 2 
Diabetes Mellitus. Ann Pharmacother. 2015;49(10):1153-61. 
23. 
Riddle MC, Yki-Jarvinen H, Bolli GB, Ziemen M, Muehlen-Bartmer I, Cissokho S, et al. One-
year sustained glycaemic control and less hypoglycaemia with new insulin glargine 300 U/ml 
compared with 100 U/ml in people with type 2 diabetes using basal plus meal-time insulin: the 
EDITION 1 12-month randomized trial, including 6-month extension. Diabetes Obes Metab. 
2015;17(9):835-42. 
24. 
Yki-Jarvinen H, Bergenstal R, Ziemen M, Wardecki M, Muehlen-Bartmer I, Boelle E, et al. New 
insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using 
oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized 
controlled trial (EDITION 2). Diabetes Care. 2014;37(12):3235-43. 
25. 
Yki-Jarvinen H, Bergenstal RM, Bolli GB, Ziemen M, Wardecki M, Muehlen-Bartmer I, et al. 
Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 
100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the 
EDITION 2 randomized 12-month trial including 6-month extension. Diabetes Obes Metab. 
2015;17(12):1142-9. 
26. 
Home PD, Bergenstal RM, Bolli GB, Ziemen M, Rojeski M, Espinasse M, et al. New Insulin 
Glargine 300 Units/mL Versus Glargine 100 Units/mL in People With Type 1 Diabetes: A 
Randomized, Phase 3a, Open-Label Clinical Trial (EDITION 4). Diabetes Care. 
2015;38(12):2217-25. 
27. 
Bolli GB, Riddle MC, Bergenstal RM, Ziemen M, Sestakauskas K, Goyeau H, et al. New insulin 
glargine 300 U/ml compared with glargine 100 U/ml in insulin-naive people with type 2 diabetes 
on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes 
Metab. 2015;17(4):386-94. 
28. 
Capes SE, Hunt D, Malmberg K, Pathak P, Gerstein HC. Stress hyperglycemia and prognosis of 
stroke in nondiabetic and diabetic patients: a systematic overview. Stroke. 2001;32(10):2426-32. 
29. 
Braithwaite SS, Buie MM, Thompson CL, Baldwin DF, Oertel MD, Robertson BA, et al. Hospital 
hypoglycemia: not only treatment but also prevention. Endocr Pract. 2004;10 Suppl 2:89-99. 
30. 
Krinsley JS. Association between hyperglycemia and increased hospital mortality in a 
heterogeneous population of critically ill patients. Mayo Clin Proc. 2003;78(12):1471-8. 
31. 
Inzucchi SE. Clinical practice. Management of hyperglycemia in the hospital setting. N Engl J 
Med. 2006;355(18):1903-11. 
32. 
Umpierrez GE, Smiley D, Hermayer K, Khan A, Olson DE, Newton C, et al. Randomized study 
comparing a Basal-bolus with a basal plus correction insulin regimen for the hospital management 
of medical and surgical patients with type 2 diabetes: basal plus trial. Diabetes Care. 
2013;36(8):2169-74. 
33. 
Gosmanov AR, Goorha S, Stelts S, Peng L, Umpierrez GE. Management of hyperglycemia in 
diabetic patients with hematologic malignancies during dexamethasone therapy. Endocr Pract. 
2013;19(2):231-5. 


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22
34. 
Farrokhi F, Klindukhova O, Chandra P, Peng L, Smiley D, Newton C, et al. Risk factors for 
inpatient hypoglycemia during subcutaneous insulin therapy in non-critically ill patients with type 
2 diabetes. J Diabetes Sci Technol. 2012;6(5):1022-9. 
35. 
Finfer S, Liu B, Chittock DR, Norton R, Myburgh JA, McArthur C, et al. Hypoglycemia and risk 
of death in critically ill patients. N Engl J Med. 2012;367(12):1108-18. 
36. 
Umpierrez GE, Reyes D, Smiley D, Hermayer K, Khan A, Olson DE, et al. Hospital Discharge 
Algorithm Based on Admission HbA1c for the Management of Patients With Type 2 Diabetes. 
Diabetes Care. 2014. 
37. 
Capes SE, Hunt D, Malmberg K, Gerstein HC. Stress hyperglycaemia and increased risk of death 
after myocardial infarction in patients with and without diabetes: a systematic overview. Lancet. 
2000;355(9206):773-8. 
38. 
Golden SH, Peart-Vigilance C, Kao WH, Brancati FL. Perioperative glycemic control and the risk 
of infectious complications in a cohort of adults with diabetes. Diabetes Care. 1999;22(9):1408-
14. 
39. 
Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, et al. Insulin analogs versus 
human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled 
trial. Diabetes Care. 2009;32(7):1164-9. 
40. 
Garner JS, Jarvis WR, Emori TG, Horan TC, Hughes JM. CDC definitions for nosocomial 
infections, 1988. Am J Infect Control. 1988;16(3):128-40. 
41. 
Umpierrez GE. Basal versus sliding-scale regular insulin in hospitalized patients with 
hyperglycemia during enteral nutrition therapy. Diabetes Care. 2009;32(4):751-3. 
42. 
Queale WS, Seidler AJ, Brancati FL. Glycemic control and sliding scale insulin use in medical 
inpatients with diabetes mellitus. Arch Intern Med. 1997;157(5):545-52. 
 


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23
XV. Appendix 1. 
Supplemental “sliding insulin scale” protocol 
 
BEFORE MEAL, Supplemental Sliding Scale – Glulisine Insulin (number of units) - Add to 
scheduled insulin dose.   
 
**Check appropriate column and cross out other columns 
BG (mg/dL)         Insulin Sensitive                          Usual                    Insulin Resistant                                
< 141 
                    No sliding scale (supplemental)insulin 
141 – 180 
2 
3 
4 
181 – 220 
3 
4 
6 
221 – 260 
4 
5 
8 
261 – 300 
5 
6 
10 
301 – 350 
6 
8 
12 
351 – 400 
7 
10 
14 
> 400 
8 
12 
16 
 
 
 
 
 
BEDTIME sliding scale: Supplemental Sliding Scale Insulin dose at bedtime starting at BG > 220 
mg/dL 
  BG (mg/dL)          Insulin Sensitive                          Usual                    Insulin Resistant                               
< 220 
                    No sliding scale (supplemental) insulin 
221 – 260 
1 
2 
4 
261 – 300 
2 
3 
5 
301 – 350 
3 
4 
6 
351 – 400 
4 
5 
7 
> 400 
5 
6 
8 
 
 
 
The numbers in each column indicate the number of units of glulisine insulin per dose.  Supplemental” 
dose is to be added to the scheduled dose of aspart insulin.  If a patient is able and expected to eat all or 
most of his/her meals, supplemental insulin will be administered before each meal following the “usual” 
column dose. Supplemental insulin at bedtime = half of premeal insulin dose.  Example, a patient with 
blood glucose of 260 mg/dl will receive 5 U before a meal or 2 U at bedtime of supplemental insulin.     
If a patient is not able to eat (NPO), supplemental insulin will be administered every 6 hours (6-12-6-12) 
following the “sensitive” column dose.  Example, a patient kept NPO with blood glucose of 200 mg/dl 
will receive 3 U of supplemental insulin.     
The patient’s inpatient primary medical or surgical team may change insulin dose at their discretion in the 
presence of hypoglycemia (BG <70 mg/dL) or severe hyperglycemia (BG >350 mg/dL).  In addition, the 
attending physician may consider using the total supplemental insulin dose, patient’s nutritional intake, 
and results of BG testing to adjust insulin regimen.    
 
 

ICF_001.pdf: 
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Page 1 of 13 
 
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Glargine U300 Hospital Trial- Ancillary Benefits of CGM 
Informed Consent Form 
 
IRB00091740 
 
 Title: Glargine U300 Hospital Trial: A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the 
Inpatient and Post-Hospital Discharge Management of Medicine and Surgery Patients with Type 2 Diabetes  
 
 
Principal Investigator: Guillermo Umpierrez, M.D. Professor of Medicine  
                                         Emory University School of Medicine 
                                         Director, Diabetes and Endocrinology Section 
 
                          Grady Health System 
 
01/28/2019 
 


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Page 2 of 13 
 
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Glargine U300 Hospital Trial- Ancillary Benefits of CGM 
  
 
 
You Are Being Asked to Be in a Research Study 
 
What Is a Research Study? 
The main purpose of research studies is to gain knowledge. This knowledge may be used to 
help others. Research studies are not intended to benefit you directly, though some might.   
 
Do I Have to Do This? 
No. Being in this study is entirely your choice.  If you decide to join this study, you can 
change your mind later on and withdraw from the research study.  
 
Taking part in a study is separate from medical care. The decision to join or not join the 
research study will not affect your status as a patient.   
 
What Is This Document? 
This form is an informed consent document. It will describe the study risks, procedures, and 
any costs to you. 
 
This form is also a HIPAA Authorization document. It will describe how your health information 
will be used and by whom. 
 
Signing this form indicates you are willing to take part in the study and allow your health 
information to be used. 
 
What Should I Do Next? 
1. Read this form, or have it read to you. 
2. Make sure the study doctor or study staff explains the study to you. 
3. Ask questions (e.g., time commitment, unfamiliar words, specific procedures, etc.)  
4. If there will be medical treatment, know which parts are research and which are 
standard care. 
5. Take time to consider this, and talk about it with your family and friends. 
 
 
 
 


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Glargine U300 Hospital Trial- Ancillary Benefits of CGM 
 
Emory University and Grady Health System 
Consent to be a Research Subject / HIPAA Authorization  
 
 
Title: Glargine U300 Hospital Trial: A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the 
Inpatient and Post-Hospital Discharge Management of Medicine and Surgery Patients with Type 2 Diabetes  
 
 
Principal Investigator: Guillermo Umpierrez, M.D. Professor of Medicine  
                                         Emory University School of Medicine 
                                         Director, Diabetes and Endocrinology Section 
 
                          Grady Health System 
 
Investigator-Sponsor: Guillermo Umpierrez, M.D. 
 
Study-Supporter: Sanofi 
This study receives support from Sanofi. Dr. Umpierrez serves as consultant to Sanofi and receives compensation for 
these services. The terms of this arrangement have been reviewed and approved by Emory University in accordance 
with its conflict of interest policies. 
 
Introduction 
You are being asked to be in a medical research study. This form is designed to tell you everything you need to think 
about before you decide if you want to be a part of the study.  It is entirely your choice.  If you decide to take part, you 
can change your mind later on and withdraw from the research study. The decision to join or not join the research 
study will not cause you to lose any medical benefits.  If you decide not to take part in this study, your doctor will 
continue to treat you. 
 
Before making your decision: 
 
Please carefully read this form or have it read to you 
 
Please listen to the study doctor or study staff explain the study to you  
 
Please ask questions about anything that is not clear 
 
You can take a copy of this consent form, to keep. Feel free to take your time thinking about whether you would like to 
participate. You may wish to discuss your decision with family or friends. Do not sign this consent form unless you have 
had a chance to ask questions and get answers that make sense to you.  By signing this form you will not give up any 
legal rights. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. law. This Web site 
will not include information that can identify you. At most the Web site will include a summary of the results. You can 
search this Web site at any time. 
 
What is the purpose of this study? 
The Food and Drug Administration and the European Commission recently approved Glargine U300 insulin for the 
treatment of patients with diabetes. Glargine U300 is long-acting insulin with duration of action longer than 24 hours. 
This pilot, randomized clinical trial will compare the efficacy and safety of a basal bolus regimen with glargine U300 and 
glargine U100 (standard of care) in general medicine and surgery patients with type 2 Diabetes (T2D). 
 


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Glargine U300 Hospital Trial- Ancillary Benefits of CGM 
The purpose of this study is to find out if treatment with glargine U300 when compared to glargine U100 will result in 
similar sugar control in patients with T2D, who are admitted to the hospital and then transition at home, after discharge 
from the hospital.  
 
We will randomize (assign to treatment 1:1) 300 subjects from 3 medical centers in the United States.  One hundred and 
fifty (150) patients will be consented at Grady Memorial Hospital, Emory University Hospital Midtown, and Emory 
University Hospital. This study has two parts: Inpatient (hospital stay) and Discharge (outpatient) part. For the inpatient 
part, we will follow you for the total length of your hospital (inpatient) stay. The discharge or outpatient part of the 
study will last three (3) months after your discharge from the hospital.   
 
For the optional sub-study:  
The purpose of this study is to determine differences in glycemic (sugar) control, frequency of low blood sugar 
determined by continuous glucose monitoring (CGM) in patients with type 2 diabetes (T2D) treated with basal bolus 
insulin regimen with glargine U300 or U100 plus glulisine (rapid acting insulin) before meals. 
About 100 subjects from 2 medical centers in the United States will wear the continuous glucose monitoring sensor.  
About fifty (50) patients will be consented at Grady Memorial Hospital, Emory University Hospital Midtown, and Emory 
University Hospital. 
 
What will I be asked to do? 
In-Patient (Hospital) Part: 
During your hospital stay, you will be assigned by random (like a flip of a coin) to one of the two treatment groups:  
1. Group 1: Basal bolus with glargine U300 once daily and glulisine insulin before meals. 
2. Group 2: Basal bolus with glargine U100 once daily and glulisine insulin before meals. 
 
The following procedures will happen: 
 
We will discontinue any oral diabetes medications that you were taking prior to your admission to the hospital.  
 
Basal (glargine U100 or glargine U300) insulin will be injected under the skin (in the abdomen, thigh or upper 
arm) once daily, at the same time of the day. 
 
Glulisine (rapid acting) insulin will be given three (3) times (with each meal) a day under the skin. 
 
You will also receive additional (supplemental or correction) insulin [rapid acting insulin analogs (glulisine)] if 
your blood sugar is greater than 140 mg/dL 
 
Blood sugar monitoring: We will measure your blood sugar levels before each meal and at bedtime (or every 6 
hours if you are not eating) using a glucose meter.  This is done at bedside by pricking your finger with a small 
needle and placing a drop of blood on a special strip to measure your blood sugar.  
 
For the optional study - benefits of continuous glucose monitoring (CGM): 
If you choose to participate in this optional study, we will ask you to wear a FreeStyle Libre Professional (continuous 
glucose monitoring) CGM sensor which is FDA-approved as an adjunctive tool in the outpatient settings to complement 
information obtained from standard self-monitored blood glucose (SMBG) and to aid in detecting hyper- (high blood 
sugar) and hypoglycemic (low blood sugar) episodes. You will wear this sensor during your hospital stay and/or 
discharge up to 14 days. This sensor will measure your sugars every 15 minutes and will allow us to review information 
on numbers of high or low blood sugars compared to the fingersticks done while you admitted to the hospital. You and 
the research team will not see in ‘real time’ blood sugar information in the hospital.  This information will be analyzed 
after your discharge from the hospital.  
 
Inpatient Diabetes Education.  Prior to discharge, you will receive training: 
 
Diabetes education if not received within 1 year of admission.  All patients will be instructed on insulin 
administration.   
 
Blood sugar targets for fasting and premeal BG between 80 to 140 mg/dL. 


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Glargine U300 Hospital Trial- Ancillary Benefits of CGM 
 
Use of glucose meters for home glucose self-monitoring (meters may vary at different institutions).   
 
Keeping sugar (BG) records and you will get a logbook to record sugar tests results. 
 
Hypoglycemia (low blood glucose) recognition and management. 
 
Outpatient-Discharge Part 
 
We  will follow your diabetes control once you have been discharged from the hospital if your HbA1C level (a 
test that tells the average blood sugar during the previous 3 months) is 7.5% or higher. 
 
Your treatment at discharge will depend on your HbA1C level. 
 
Your participation in the Discharge Protocol will last about 3 months. 
 
Once you complete all study visits at 3months, we will ask you to continue your diabetes care with your primary 
care physician. 
 
The Discharge Part will be carried out as follows: 
We will ask you to monitor your blood sugar. Blood sugar levels will be measured at home by finger stick before meals 
two or three times per day.  This is the standard care for patients after leaving the hospital.  Blood glucose levels will be 
used to tell how you respond to treatment. 
 
We will ask that if you have any blood sugar less than 70 mg/dL, to write it down in a diary along with how you treated 
it. Please call the site or your health care provider if you have very low blood sugar, and you asked for the assistance of 
another person. 
 
Follow-up Care-Discharge Part: 
 
After discharge, a member of the diabetes research team will contact you via telephone every 2 weeks to assess 
response to therapy. In addition, we will ask you to attend an outpatient clinic visit at 1 and 3 months after 
hospital discharge. An optional telephone call or clinic visit may be done at one week following discharge to 
ensure that you are taking the medication(s) and have sufficient supplies. 
 
We will provide the insulin (glargine U300 or glargine U100) to you. Any oral anti-diabetic medications are 
standard of care; therefore, we will not provide these medications after discharge. 
 
At discharge, you will receive a one-month supply of insulin (glargine U300 or glargine U100). We will not 
provide testing supplies or insulin syringes (this is standard of care for patients with diabetes).  
 
We will ask you to attend an outpatient clinic visit within one month after hospital discharge.  During this visit, 
you will receive a 2-month supply of insulin (glargine U300 or glargine U100). We will not provide testing 
supplies or insulin syringes (this is standard of care for patients with diabetes. We will ask you to return to the 
research center 2 months later (3 months after discharge visit).  
 
A licensed physician (fellow or study physician) will provide recommendations on how to adjust insulin after 
each telephone contact and clinic visit. 
 
We will adjust insulin dose as per your blood sugar test results.  You may need to receive less or more insulin if 
your blood sugar is low or high. This is the standard or usual care for patients with diabetes. 
 
You should continue your diabetes care with your primary care provider once you complete the study (3 months 
after your hospital discharge). 
 
During each one of your outpatient (discharge part) visits, we will collect and measure the following: 
Vital Signs: 
 
Blood pressure 
 
Heart rate 
 
Temperature 
 
Respiratory rate 
 


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Glargine U300 Hospital Trial- Ancillary Benefits of CGM 
Body measurements: 
 
Body weight 
 
Height 
 
Laboratories: 
 
Measurement of your fating blood sugar by finger stick (fasting for at least 8 hours, nothing to eat or to drink, 
except water), 
 
Urine pregnancy test if you are a woman of childbearing age, 
 
Draw about 1 tablespoon of blood from a vein from one of your arms to check your A1C that tells the average 
blood sugar during the previous 3 months and chemistry (kidney function, electrolytes) test. 
 
How will my medicine be provided?  
The medicine that you will take will be dispensed by the pharmacy and delivered to your nurse while you are at the 
hospital, once you are discharged from the hospital, the pharmacy will deliver the study medication to the principal 
investigator or study team member.  The principal investigator or health care providers on his/her research team will 
provide the medicine to you.  If you have questions about the medicine, you should ask the principal investigator or 
study nurse.  You may also call the pharmacy if you have questions about the medicine. The number for the pharmacy is 
included on your medicine package. 
 
For the optional study:  
We will place the FreeStyle Libre Professional CGM sensor in the back of one of your upper arms. We will clean the area 
with an alcohol wipe and allow the site to dry. We will place the Sensor Applicator over the prepared area and push 
down firmly to apply the Sensor to your body. Applying the Sensor may cause some mild bruising or bleeding. If there is 
bleeding that does not stop, we will remove the Sensor, and apply a new one at a different site. 
Who owns my study information and samples? 
If you join this study, you will be donating your study information.  You will not receive any compensation if your 
information are used to make a new product. If you withdraw from the study, data that were already collected may be 
still be used for this study.  If you desire, you can request that your study information be destroyed. 
 
What are the possible risks and discomforts? 
There may be side effects from the study drug that are not known at this time.   
 
The most common risks and discomforts expected in this study are: 
 
Risks from Blood Draw 
The risks of taking blood include pain, a bruise at the point where the blood is taken, redness and swelling of the vein 
and infection, and a rare risk of dizziness and fainting. 
 
For all medications: Glargine U300, Glargine U100 and glulisine (all are insulin medications): 
 
Low blood sugar (hypoglycemia)  
Low blood sugar (less than 70 mg/dl) can occur in about 20% (20 patients out of one hundred) of insulin treated patients 
in the hospital. Symptoms of low blood glucose include sweating, nervousness, confusion, agitation, sleepiness and even 
coma (loss of awareness).  If it occurs, low sugar will be managed by a standard protocol, including decreasing the 
amount of insulin and by the use of dextrose (sugar) solution. 
 
Low blood sugar can be treated by taking some form of sugar, such as juice, honey, or hard candies/jellybeans. If 
hypoglycemia (low blood sugar) becomes severe, accidents, injuries, coma, or death may occur. To raise blood glucose 


Study No.: «ID» 
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Page 7 of 13 
 
Version Date: 01.28.2019 
Glargine U300 Hospital Trial- Ancillary Benefits of CGM 
(sugar) levels in persons having a severe hypoglycemic episode, glucose (sugar) may need to be given IV. In rare cases, 
glucagon (a protein that stimulates the liver to increase blood glucose [sugar] levels) may be given.  
 
To know if you have low blood sugar, the site staff will check your blood sugar frequently during the time you are staying 
at the study site. At home, you will check your own blood sugar. We will review your blood sugar levels at each clinic 
visit. We will also ask you to write down any blood sugar that is less than 70 mg/dL, any symptoms you had and what did 
you do to treat the low blood sugar.  
 
Shot (Injection) Site and Allergic Reactions:  Shot site reactions with insulin includes redness, pain, itching, hives and 
swelling. Regularly changing of the place where insulin is given may help to reduce or prevent these reactions.  Most 
minor reactions resolve in a few days to a few weeks.  Generalized allergy is rare and may cause skin rash, shortness of 
breath, fast heartbeat, sweating and a drop in blood pressure.  
 
The less common risks and discomforts expected in this study are: 
 
Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Glargine or Glulisine may cause heart 
failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already 
have heart failure, it may get worse while you take TZDs with glargine. Your healthcare provider should monitor you 
closely while you are taking TZDs with glargine Tell your healthcare provider if you have any new or worse symptoms of 
heart failure including shortness of breath, tiredness, swelling of your ankles or feet and sudden weight gain. Treatment 
with TZDs and glargine may need to be adjusted or stopped by your healthcare provider if you have new or worse heart 
failure. 
If you are a woman: to protect against possible side effects of the study drug, women who are pregnant or nursing a 
child may not take part in this study. If you become pregnant, there may be risks to you, the embryo, or fetus. These 
risks are not yet known. If you are a woman of childbearing ability, you and the study doctor must agree on a method of 
birth control to use throughout the study.  If you think that you have gotten pregnant during the study, you must tell the 
study doctor immediately.  Pregnant women will be taken out of the study. 
 
If you will be taking the study drug home, keep it out of the reach of children or anyone else who may not be able to 
read or understand the label.  Do not let anyone else take the study drug besides you. 
 
It is possible that the researchers will learn something new during the study about the risks of being in it.  If this 
happens, they will tell you about it. Then you can decide if you want to continue to be in this study or not.  You may be 
asked to sign a new consent form that includes the new information if you decide to stay in the study. 
Will I benefit directly from the study?  
This study is not designed to benefit you directly.  Your diabetes may improve while you are in this study but it may not, 
and it may even get worse.  This study is designed to learn more about management of diabetes type 2. The study 
results may be used to help others in the future. 
Will I be compensated for my time and effort? 
For participation in the main study, you will receive one hundred dollars ($100.00) prior to discharge (leaving the 
hospital).  If you stop the study before it is over, you will receive $10.00 per day to a maximum of $100.00 during the 
hospital stay. In addition, for the outpatient portion of the study, you will get seventy-five dollars ($75.00) for each 
outpatient completed in-person visit. If you do not finish the study, we will compensate you for the visits you have 
completed.  Total compensation for participation in the main study (hospital and discharge studies) is two hundred and 
fifty dollars ($250.00). 


Study No.: «ID» 
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For participation in the ancillary optional sub study you will receive fifty dollars ($50.00) after removal of the sensor.  If a 
participant should stop participation before completion, the payment will be prorated at $10.00 per day to a maximum 
of $50.00. Total compensation for participation in this ancillary trial will be fifty dollars ($50.00) 
What are my other options? 
Since this study is not intended to provide any therapeutic or other health-related benefit, your alternative is not to take 
part in this study.   If you choose not to join this study, there is care available to you outside of this research. 
 
There are many medications to treat high blood sugar levels in persons with diabetes.  If you have any questions about 
treatments, please ask your study doctor. You and your doctor can choose what is best for you. You do not have to be in 
this study get treatment for diabetes. 
 
Taking part in this study, however, may make you unable to participate in some other research studies, if they exclude 
people who have taken certain treatments.  You should discuss this with the researchers if you have concerns. You may 
wish to research other study options at websites like clinicaltrials.gov and ResearchMatch.org. 
 
How will you protect my private information that you collect in this study? 
Emory and Grady Health System will keep any research records that it creates private to the extent that this is required 
to do so by law.  Whenever possible, a study number, rather than your name, will be used on study records.  Your name 
and other identifying information will not appear when we present or publish the study results. 
 
Study records can be opened by court order.  They also may be provided in response to a subpoena or a request for the 
production of documents.  
 
Storing and Sharing your Information 
Your health information will be stored and shared with other researchers. The information will be available for any 
research question, such as research to understand what causes certain diseases (for example heart disease, cancer, or 
psychiatric disorders), development of new scientific methods, or the study of where different groups of people may 
have come from. 
 
Medical Record 
If you have been an Emory and Grady Health System patient before, then you already have an Emory and Grady Health 
System medical record.  If you have never been an Emory and Grady Health System patient, you do not have one.   An 
Emory and Grady Health System medical record will be made for you if an Emory and Grady Health System provider or 
facility gives you any services or procedures for this study.   
 
Copies of the consent form/HIPAA authorization that you sign will be put in any Emory and Grady Health System medical 
record you have now or any time during the study.   
 
Emory and Grady Health System may create study information about you that can help with your care.  For example, the 
results of study tests or procedures.  These study results will be put in your Emory and Grady Health System medical 
record. Anyone who has access to your medical records will be able to have access to all the study information placed 
there.  The confidentiality of the study information in your medical record will be protected by laws like the HIPAA 
privacy rule.  State and federal laws may not protect the research information from disclosure.   
 
Tests and procedures done at non-Emory and Grady Health System places may not become part of your Emory and 
Grady Health System medical record. Also, if you decide to be in this study, it is up to you to let your other health 
providers know.  
 


Study No.: «ID» 
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In Case of Injury 
If you get ill or injured from being in the study, Emory and Grady Health System will help you get medical treatment.  
You should let the study doctor know right away that you are ill or injured.  If you believe you have become ill or injured 
from this study, you should contact Dr. Guillermo Umpierrez at telephone number 404-778-1665. You should also let 
any health care provider who treats you know that you are in a research study.  
If you get ill or injured as the direct result of being in this study, the sponsor will pay the costs for your medical 
treatment of the illness or injury if it: 
(a) is not a medical condition that you had before you started the study; 
(b) is not the result of the natural progress of your disease or condition; 
(c) is not caused by your failure to follow the study plan; and   
(d) is not proven to be directly caused by the negligence of an Emory or sponsor employee.  “Negligence” is the 
failure to follow a standard duty of care.  
If you have Medicare or Medicaid: the sponsor may need information about your identity and your study treatment to 
give to the government agencies that run these programs.  
Your insurance will be billed for any costs of medical treatment for your injury or illness that the sponsor does not pay.  
Your insurer may be told that you are in a research study. If you do not have insurance, or if your insurance does not 
pay, then you will have to pay these costs.  
Emory and Grady Health System have not set aside any money to pay you or to pay for your treatment if you get ill or 
injured from being in the study.  The only exception to this policy is if it is proved that your injury or illness is directly 
caused by the negligence of an Emory or sponsor employee.  
Costs 
 
The study sponsor will pay for certain items and services that you may receive if you take part in this study.   
 
You will have to pay for the items or services for which the study sponsor does not pay. The sponsor will not pay for your 
regular medical care. If you have insurance, Emory and Grady Health System will submit claims to your insurance for 
items and services that the sponsor does not cover.  Emory and Grady Health System will send in only those claims for 
items and services that it reasonably believes your insurance will pay and that the sponsor has not paid.  
 
The actual amount that you have to pay depends on whether or not you have health insurance and whether or not that 
insurance will pay for any research study costs. Generally, insurance companies will not pay for items and services that 
are required just for a research study. Some insurance companies will not pay for regular medical treatment or 
treatment for complications if you are in a study.  How much you will have to pay for any co-payments, deductibles or 
co-insurance depends on your plan.  Emory and Grady Health System and the sponsor will not pay for these costs.  
 
It is a good idea to contact your insurance provider and tell them you want to be in this research study.  Ask them what 
they will pay for and what they will not pay for.  You can also ask the study team for help in figuring out what you will 
have to pay.  
 
If you do not have insurance, Emory and Grady Health System will review your case as part of its program for low-
income patient care.  The standard policies of that program will apply.  The program will figure out if you have to pay 
any costs for taking part in the study and what those costs will be. 


Study No.: «ID» 
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Document Approved On: «ApproveDate» 
 
 
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Withdrawal from the Study 
You have the right to leave a study at any time without penalty.   
 
The researchers also have the right to stop your participation in this study without your consent for any reason, especially if 
they believe it is in your best interest or if you were to object to any future changes that may be made in the study plan. 
 
Authorization to Use and Disclose Protected Health Information 
 
The privacy of your health information is important to us.  We call your health information that identifies you, your 
“protected health information” or “PHI.”  To protect your PHI, we will follow federal and state privacy laws, including the 
Health Insurance Portability and Accountability Act and regulations (HIPAA).  We refer to all of these laws as the “Privacy 
Rules.”  Here we let you know how we will use and disclose your PHI for the main study (inpatient and discharge parts of 
the hospital) and for the optional benefits of CGM study which you may choose to participate. 
 
PHI that will be Used/Disclosed:   
The PHI that we will use or share for the main research study includes: 
 
Medical information about you including your medical history and present/past medications. 
 
Results of exams, procedures and tests you have before and during the study. 
 
Laboratory test results. 
 
Purposes for Which Your PHI will be Used/Disclosed: 
We will use and share your PHI for the conduct and oversight of the research study.  We will use and share your 
PHI to provide you with study related treatment and for payment for such treatment.  We will also use and 
share your PHI to conduct normal business operations.  We may share your PHI with other people and places 
that help us conduct or carry out the study, such as laboratories, data management centers, data monitors, 
contract research organizations, Institutional Review Boards (IRBs) and other study sites. If you leave the study, 
we may use your PHI to determine your health, vital status or contact information. 
 
Use and Disclosure of Your Information That is Required by Law:   
We will use and disclose your PHI when we are required to do so by law. This includes laws that require us to 
report child abuse or abuse of elderly or disabled adults. We will also comply with legal requests or orders that 
require us to disclose your PHI. These include subpoenas or court orders.   
 
Authorization to Use PHI is required to Participate: 
By signing this form, you give us permission to use and share your PHI as described in this document. You do not 
have to sign this form to authorize the use and disclosure of your PHI.  If you do not sign this form, then you may 
not participate in the research study or receive research-related treatment.  You may still receive non-research 
related treatment.   
 
People who will Use/Disclose Your PHI: 
The following people and groups will use and disclose your PHI in connection with the research study: 
 
 
The Principal Investigator and the research staff will use and disclose your PHI to conduct the study and 
give you study related treatment. 
 
Emory and Grady Health System may use and disclose your PHI to get payment for study related 
treatment and to run normal business operations. c 
 
The Principal Investigator and research staff will share your PHI with other people and groups to help 
conduct the study or to provide oversight for the study. 


Study No.: «ID» 
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 
 Dr. Umpierrez is the Sponsor of the study.  The Sponsor may use and disclose your PHI to make sure the 
research is done correctly and to collect and analyze the results of the research.  The Sponsor may 
disclose your PHI to other people and groups like study monitors to help conduct the study or to provide 
oversight for the study.   
 
The research team and the Sponsor may use and disclose your PHI, including disclosure to insurance 
carriers to administer payment for subject injury.  
 
The following people and groups will use your PHI to make sure the research is done correctly and 
safely: 
o Emory and Grady Health System offices that are part of the Human Research Participant 
Protection Program and those that are involved in study administration and billing.  These 
include the Emory IRBs, the Grady Research Oversight Committee, the Emory Research and 
Compliance Offices, and the Emory Office for Clinical Research.  
o Government agencies that regulate the research including:  Food and Drug Administration; 
Public health agencies. 
o Research monitors and reviewer. 
o Accreditation agencies. 
 
Sometimes a Principal Investigator or other researcher moves to a different institution. If this happens, 
your PHI may be shared with that new institution and their oversight offices. PHI will be shared securely 
and under a legal agreement to ensure it continues to be used under the terms of this consent and 
HIPAA authorization. 
 
Optional Sub-Study 
There is an optional research Sub-Study related to the main study. It is your choice to join or not to join this sub-
study.  If you choose to join, you can change your mind later on and leave the study. If you choose not to join 
the Sub-Study, you may still join in the main study. The FreeStyle Libre Pro CGM will be inserted shortly after 
giving consent. You will use the sensor during the first 14 days of treatment. No major risks are expected with 
the use of the CGM sensor. Pain and bleeding with insertion is minimal.  Skin irritation may occur in those 
sensitive to adhesives 
 
Optional Study/Storage of Data:  
 
PHI That Will be Used/Disclosed for Optional Study:   
The PHI that we will use and/or disclose (share) for the optional research study includes: 
o Medical information about you including your medical history and present/past medications. 
o Results of exams, procedures and tests you have before and during the study. 
o Laboratory test results ___  
 
Purposes for which your PHI will be Used/Disclosed for Optional Study: 
We will use and disclose your PHI for the conduct and oversight of the optional research study. 
  
Authorization for This Use of PHI is Required to Participate in Optional Study, but Not in Main Study: 
You do not have to authorize the use and disclosure of your PHI.  If you do not authorize the use and disclosure 
of your PHI for the optional study, then you may not participate in the optional research study.  You can still be 
in the main research study even if you don’t participate in the optional study.    
 
People Who Will Use/Disclose Your PHI for Optional Study: 
 
The same people and groups who will use and disclose your PHI for the Main Study will also do so in connection 
with the optional research study of PHI for future research.  
 


Study No.: «ID» 
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Expiration of Your Authorization 
Your PHI will be used until this research study ends. 
 
Revoking Your Authorization 
If you sign this form, at any time later you may revoke (take back) your permission to use your information.  If you want 
to do this, you must contact Dr. Guillermo Umpierrez at:  
69 Jesse Hill Jr. Dr. SE, Atlanta, GA 30303 
 
At that point, the researchers would not collect any more of your PHI.  But they may use or disclose the information you 
already gave them so they can follow the law, protect your safety, or make sure that the study was done properly and 
the data is correct.  If you revoke your authorization you will not be able to stay in the study.  
 
 
Other Items You Should Know about Your Privacy 
Not all people and entities are covered by the Privacy Rules.  HIPAA only applies to health care providers, health care 
payers, and health care clearinghouses.  If we disclose your information to people who are not covered by the Privacy 
Rules, including HIPAA, then your information won’t be protected by the Privacy Rules.  People who do not have to 
follow the Privacy rules can use or disclose your information with others without your permission if they are allowed to 
do so by the laws that cover them.  The Sponsor, and people and companies working with the Sponsor on this study are 
not covered by the Privacy Rules.  They will only use and disclose your information as described in this Consent and 
Authorization.  
 
To maintain the integrity of this research study, you generally will not have access to your PHI related to this research 
until the study is complete.  When the study ends, and at your request, you generally will have access to your PHI that 
we maintain in a designated record set.  A designated record set is data that includes medical information or billing 
records that your health care providers use to make decisions about you. If it is necessary for your health care, your 
health information will be provided to your doctor.  
 
We may remove identifying information from your PHI.  Once we do this, the remaining information will not be subject 
to the Privacy Rules.  Information without identifiers may be used or disclosed with other people or organizations for 
purposes besides this study.   
 
Contact Information 
Contact Dr. Guillermo Umpierrez at 404-778-1665: 
 
if you have any questions about this study or your part in it,   
 
if you feel you have had a research-related injury or a bad reaction to the study drug, or 
 
if you have questions, concerns or complaints about the research 
 
Contact the Emory Institutional Review Board at 404-712-0720 or 877-503-9797 or irb@emory.edu: 
 
If you have questions about your rights as a research participant. 
 
If you have questions, concerns or complaints about the research. 
 
You may also let the IRB know about your experience as a research participant through our Research Participant 
Survey at http://www.surveymonkey.com/s/6ZDMW75. 
 
If you are a patient receiving care from the Grady Health System and have a question about your rights, you may contact the 
Office of Research Administration at research@gmh.edu. 


Study No.: «ID» 
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Document Approved On: «ApproveDate» 
 
 
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Consent and Authorization 
 
Consent and HIPAA Authorization for Optional Study:   
Please initial below if you opt to participate in and authorize use and disclosure of your PHI in the optional study/studies 
previously described: 
 
Benefits of CGM:      
 
________ 
Initials 
 
OR 
 
I agree to participate in the benefits of continuous glucose monitoring (CGM). 
 
________ 
Initials 
I do not agree to participate in in the benefits of continuous glucose monitoring (CGM). 
 
 
TO BE FILLED OUT BY SUBJECT ONLY 
Please print your name, sign, and date below if you agree to be in the study. By signing this consent and authorization 
form, you will not give up any of your legal rights. We will give you a copy of the signed form to keep. 
 
 
 
Name of Subject  
 
 
 
 
  
Signature of Subject (18 or older and able to consent) 
Date              Time 
 
 
 
 
 
Signature of Legally Authorized Representative with authority for 
Date              Time 
Research decisions 
 
 
 
Authority of Legally Authorized Representative or Relationship to Subject 
 
TO BE FILLED OUT BY STUDY TEAM ONLY 
 
__________________________________________________________ 
Name of Person Conducting Informed Consent Discussion 
 
 
 
 
 
Signature of Person Conducting Informed Consent Discussion 
Date              Time