GLP-1 Agonist AVE0010 in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insuli

Phase 3

Completed

• Conditions: Health Condition 1: null- In Patients With Type 2 Diabetes insufficiently controlled with basal insulin for the assessment of the efficacy and Safety EvaluationHealth Condition 2: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2008/091/000180
• Lead Sponsor: Sanofi Synthelabo A Sir Mathuradas Vasanji Road AndheriE Mumbai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 496

Inclusion Criteria

Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with basal insulin with or without metformin

Exclusion Criteria

1. HbA1c <7% or >10%

2. Pregnant or breastfeeding women or women of childbearing
potential with no effective contraceptive method

3. Basal insulin < 30 U/day or not at a stable dose (± 20%) for at
least 3 months prior to screening.

4. Body mass index < 20 kg/m2

5. Weight change of more than 5 kg during the 3 months
preceding the study

6. Participation in any previous study with AVE0010
Use of any investigational drug within 3 months prior to study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absolute change from baseline in HbA1c <br/ ><br>Timepoint: 24 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in body weightTimepoint: 24 weeks;Change from baseline in fasting plasma glucoseTimepoint: 24 weeks;Change from baseline in insulin dosesTimepoint: 24 weeks