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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: AVE2268

Study type

Interventional

Funder types

Industry

Identifiers

NCT00361738

DRI6738

EUDRACT: 2006-001843-74

Details and patient eligibility

About

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.

Enrollment

317 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

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.