Status:

COMPLETED

Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus

Lead Sponsor:

Sanofi

Conditions:

Type 2 Diabetes

Eligibility:

All Genders

30-75 years

Phase:

PHASE2

Brief Summary

To evaluate the dose-response relationship of AVE0010 administered once daily and twice daily with chronic dosing in metformin-treated subjects with type 2 diabetes

Eligibility Criteria

Inclusion

  • Males, females, age 30, - 75 years, type 2 diabetes mellitus, treated with metformin ≥1.0 g/day, at a stable dose for at least 3 months, BMI 25 - 40 kg/m2, HbA1C ≥7.0% and \<9.0%.

Exclusion

  • Type 1 diabetes, pregnancy, lactation, women of childbearing potential, treatment with other antidiabetic agents than metformin, history of metabolic acidosis, hemoglobinopathy or hemolytic anemia, clinically significant medical abnormalities.

Key Trial Info

Start Date :

February 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2007

Estimated Enrollment :

542 Patients enrolled

Trial Details

Trial ID

NCT00299871

Start Date

February 1 2006

End Date

August 1 2007

Last Update

January 28 2014

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States, 08807

2

Sanofi-Aventis Administrative Office

São Paulo, Brazil

3

Sanofi-Aventis Administrative Office

Laval, Canada

4

Sanofi-Aventis Administrative Office

Warsaw, Poland