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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00361738
First received: August 7, 2006
Last updated: February 6, 2009
Last verified: February 2009
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)
  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT00361738

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

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00361738     History of Changes
Other Study ID Numbers: DRI6738, EUDRACT: 2006-001843-74
Study First Received: August 7, 2006
Last Updated: February 6, 2009
Health Authority: South Africa: Medicines Control Council
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Germany: Ethics Commission

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
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014