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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT00361738
• Lead Sponsor: Sanofi

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-08-07
• Study First Submitted QC: 2006-08-07
• Study First Posted: 2006-08-08
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Mean Plasma Glucose (MPG) from baseline to week 4.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇿🇦 Midrand, South Africa