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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00299871
First received: March 6, 2006
Last updated: January 27, 2014
Last verified: January 2014

March 6, 2006
January 27, 2014
February 2006
August 2007   (final data collection date for primary outcome measure)
HbA1c levels at baseline and endpoint (at 13 weeks).
Same as current
Complete list of historical versions of study NCT00299871 on ClinicalTrials.gov Archive Site
Fructosamine, fasting plasma glucose, fasting serum insulin, proinsulin, C-peptide, glucagon.
Same as current
Not Provided
Not Provided
 
Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus
A 13-week Multinational, Randomized, Double-Blind, Placebo-Controlled, Dose-Response Trial Assessing the Safety, Tolerability and Efficacy of AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
Drug: LIXISENATIDE (AVE0010)
Not Provided
Ratner RE, Rosenstock J, Boka G; DRI6012 Study Investigators. Dose-dependent effects of the once-daily GLP-1 receptor agonist lixisenatide in patients with Type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled trial. Diabet Med. 2010 Sep;27(9):1024-32. doi: 10.1111/j.1464-5491.2010.03020.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
542
August 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Canada,   Poland,   Romania,   Russian Federation,   Ukraine
 
NCT00299871
DRI6012
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP