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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00299871
• Other study ID #: DRI6012
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2006
• Last updated: January 27, 2014
• Start date: February 2006
• Est. completion date: August 2007

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 542
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• LIXISENATIDE (AVE0010)

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo
Canada	Sanofi-Aventis Administrative Office	Laval
Poland	Sanofi-Aventis Administrative Office	Warszawa
Romania	Sanofi-Aventis Administrative Office	Bucuresti
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Ukraine	Sanofi-Aventis Administrative Office	Kiev
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Poland,  Romania,  Russian Federation,  Ukraine, 

References & Publications (1)

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-control — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c levels at baseline and endpoint (at 13 weeks).
Secondary	Fructosamine, fasting plasma glucose, fasting serum insulin, proinsulin, C-peptide, glucagon.