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 |
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
33
sites
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Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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