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Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00299871
First received: March 6, 2006
Last updated: January 27, 2014
Last verified: January 2014
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Type 2 Diabetes | Drug: LIXISENATIDE (AVE0010) | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- HbA1c levels at baseline and endpoint (at 13 weeks).
Secondary Outcome Measures:
- Fructosamine, fasting plasma glucose, fasting serum insulin, proinsulin, C-peptide, glucagon.
| Enrollment: | 542 |
| Study Start Date: | February 2006 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299871
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299871
Locations
| 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 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | ICD CSD | Sanofi |
More Information
Publications:
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00299871 History of Changes |
| Other Study ID Numbers: |
DRI6012 |
| Study First Received: | March 6, 2006 |
| Last Updated: | January 27, 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 Metformin Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 26, 2017