Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT00299871 |
Recruitment Status
:
Completed
First Posted
: March 7, 2006
Last Update Posted
: January 28, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes | Drug: LIXISENATIDE (AVE0010) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 542 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | August 2007 |
Actual Study Completion Date : | August 2007 |

- HbA1c levels at baseline and endpoint (at 13 weeks).
- Fructosamine, fasting plasma glucose, fasting serum insulin, proinsulin, C-peptide, glucagon.

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Ages Eligible for Study: | 30 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299871
United States, New Jersey | |
Sanofi-Aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Brazil | |
Sanofi-Aventis Administrative Office | |
Sao Paulo, Brazil | |
Canada | |
Sanofi-Aventis Administrative Office | |
Laval, Canada | |
Poland | |
Sanofi-Aventis Administrative Office | |
Warszawa, Poland | |
Romania | |
Sanofi-Aventis Administrative Office | |
Bucuresti, Romania | |
Russian Federation | |
Sanofi-Aventis Administrative Office | |
Moscow, Russian Federation | |
Ukraine | |
Sanofi-Aventis Administrative Office | |
Kiev, Ukraine |
Study Director: | ICD CSD | Sanofi |
Publications of Results:
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00299871 History of Changes |
Other Study ID Numbers: |
DRI6012 |
First Posted: | March 7, 2006 Key Record Dates |
Last Update Posted: | January 28, 2014 |
Last Verified: | January 2014 |
Keywords provided by Sanofi:
Type 2 diabetes |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Lixisenatide Metformin Hypoglycemic Agents Physiological Effects of Drugs |