A randomized, double-blind, placebo-controlled, parallel-group, multicenter 24-week study followed by an extension assessing the efficacy and safety of AVE0010 on top of metformin in patients with type 2 diabetes not adequately controlled with metformin.

Registry ID
EUCTR2007-005880-80
Source registry
EUCTR
Status
Completed
Phase
PHASE3
Sponsor
Sanofi-Aventis Recherche & Développement
Start date
2008-04-30
Completion date
2011-03-09
Last update
2026-08-16

Conditions

Summary

The primary objective of this study is to assess the efficacy of AVE0010 on glycemic control when it is used in the morning within 1 hour prior to the meal in comparison to placebo as an addon treatment to metformin in terms of HbA1c reduction (absolute change) over a period of 24 weeks in patients with type 2 diabetes.

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