Status:
COMPLETED
Dose-Ranging Study Evaluating AVE2268 in Patients With Type 2 Diabetes Not Adequately Controlled by a Metformin Treatment
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief Summary
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 Me...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
317 Patients enrolled
Trial Details
Trial ID
NCT00361738
Start Date
July 1 2006
End Date
January 1 2008
Last Update
February 9 2009
Active Locations (11)
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1
Sanofi-Aventis Administrative Office
San Isidro, Argentina
2
Sanofi-Aventis Administrative Office
Cove, New South Wales, Australia
3
Sanofi-Aventis Administrative Office
Diegem, Belgium
4
Sanofi-Aventis Administrative Office
Santiago, Chile