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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
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: LIXISENATIDE (AVE0010) Phase 2

Study Design
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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

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. HbA1c levels at baseline and endpoint (at 13 weeks).

Secondary Outcome Measures :
  1. Fructosamine, fasting plasma glucose, fasting serum insulin, proinsulin, C-peptide, glucagon.

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
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
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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


Locations
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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
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Study Director: ICD CSD Sanofi
More Information
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Publications of Results:

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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:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Lixisenatide
Hypoglycemic Agents
Physiological Effects of Drugs