Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agent Failure



Status:Archived
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:July 2010
End Date:June 2012

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A 24-week, Multicenter, International, Randomized (1:1), Parallel-group, Open-label, Comparative Study of Insulin Glargine Versus Liraglutide in Insulin-naïve Patients With Type 2 Diabetes Treated With Oral Agents and Not Adequately Controlled, Followed by a 24-week Extension Period With Insulin Glargine for Patients Not Adequately Controlled With Liraglutide


Primary objective:

To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage
of patients reaching a Glycosylated Haemoglobin (HbA1c) < 7% at the end of the comparative
period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents

Secondary objectives of the comparative period (24 weeks):

>To assess the effect of insulin glargine in comparison with liraglutide on:

- HbA1c level

- Percentage of patients whose HbA1c has decreased but remains >= 7% at the end of the
comparative period

- Percentage of patients whose HbA1c has increased at the end of the comparative period

- Fasting Plasma Glucose (FPG)

- 7-point Plasma Glucose (PG) profiles

- Hypoglycemia occurrence

- Body weight

- Adverse events

Objectives of the extension period (24 weeks):

>To assess the effect of insulin glargine in patients not adequately controlled with
liraglutide on:

- HbA1c level

- FPG

- 7-point PG profiles

- Hypoglycemia occurrence

- Body weight

- Adverse events


The maximum estimated study duration per patient will be approximately 51 weeks broken down
as follow:

- A 2-week of screening period,

- A 24-week comparative period,

- A 24-week extension period (only for patients treated with liraglutide, not adequately
controlled at the end of the comparative period),

- A 1-week follow-up period


We found this trial at
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9143 Philips Hwy # 560
Jacksonville Beach, Florida 32250
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Arlington Heights, Illinois 60004
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1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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