Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure — EAGLE  

Diabetes Mellitus, Type 2 Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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

Clinical Trial Description

Maximum estimated study duration per patient: either 27 weeks (patients randomized to insulin glargine arm) or 51 weeks (patients randomized to liraglutide arm) 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

• NCT number: NCT01117350
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 4
• Start date: July 2010
• Completion date: March 2013