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Dose-Ranging Study Evaluating AVE2268 in Patients With Type 2 Diabetes Not Adequately Controlled by a Metformin Treatment

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: August 8, 2006
Last Update Posted: February 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:

Dose-ranging study of AVE2268 in the management of patients with type 2 diabetes mellitus also receiving metformin.

Its main objectives will be to assess the effects of several doses of AVE2268 on Mean Plasma Glucose. Its secondary objectives will be to assess the effects of AVE2268 on plasma glucose (fasting and post-prandial), and also the safety and tolerability of AVE2268.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: AVE2268 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Response, Multicentre, Multinational Study Evaluating the Efficacy and Safety of AVE2268 Administered Either Twice Daily (Breakfast and Lunch) at a Dose of 300, 600 and 1200 mg or Once Daily (Breakfast) at a Dose of 1200 mg, in Patients With Type 2 Diabetes Treated With Metformin and Not Adequately Controlled

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in Mean Plasma Glucose (MPG) from baseline to week 4.

Secondary Outcome Measures:
  • Glucose parameters (change from baseline to week 4 in fasting and post prandial plasma glucose) ; Change in HbA1c and fructosamine ; Safety: physical examination, adverse events, ECG, laboratory tests

Enrollment: 317
Study Start Date: July 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 diabetes mellitus, as defined by the American Diabetes Association, for at least one year at the time of screening.
  • HbA1c measured at visit 1 in the range of ≥ 7.0 and < 9.0 %.
  • Stable metformin treatment (dose ≥ 1.5g/day for at least 3 months prior to enrollment in the study). No other antidiabetic medications are permitted for 3 months prior to enrollment.

Exclusion Criteria:

  • Pregnant or breast-feeding women.
  • Women of childbearing potential not protected by medically approved contraceptive method of birth control.
  • BMI >40kg/m2
  • Diabetes other than type 2 diabetes.
  • Subjects with "brittle-diabetes" or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months, previous history of diabetes related dehydration leading to hospitalization, history or evidence of ketoacidosis.
  • Presence or history of cancer within the past five years.
  • Evidence within the past 6 months of myocardial infarction, stroke, retinopathy requiring laser surgery, or heart failure requiring hospitalization.
  • Impaired hepatic tests, impaired renal function.
  • History or evidence of clinically relevant renal or urological disorder.
  • The investigator will evaluate whether there are other reasons why a patient may not participate.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00361738

Sanofi-Aventis Administrative Office
San Isidro, Argentina
Australia, New South Wales
Sanofi-Aventis Administrative Office
Cove, New South Wales, Australia
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Santiago, Chile
Sanofi-Aventis Administrative Office
Horsholm, Denmark
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Milano, Italy
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Sanofi-Aventis Administrative Office
Warszawa, Poland
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Sponsors and Collaborators
Study Director: Elisabeth SOUHAMI, M.D Sanofi
  More Information

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00361738     History of Changes
Other Study ID Numbers: DRI6738
EUDRACT: 2006-001843-74
First Submitted: August 7, 2006
First Posted: August 8, 2006
Last Update Posted: February 9, 2009
Last Verified: February 2009

Keywords provided by Sanofi:
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs