Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
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