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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361738
• Other study ID #: DRI6738
• Secondary ID: EUDRACT: 2006-00
• Status: Completed
• Phase: Phase 2
• First received: August 7, 2006
• Last updated: February 6, 2009
• Start date: July 2006
• Est. completion date: January 2008

Study information

• Verified date: February 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control CouncilArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• AVE2268

Locations

Country	Name	City	State
Argentina	Sanofi-Aventis Administrative Office	San Isidro
Australia	Sanofi-Aventis Administrative Office	Cove	New South Wales
Belgium	Sanofi-Aventis Administrative Office	Diegem
Chile	Sanofi-Aventis Administrative Office	Santiago
Denmark	Sanofi-Aventis Administrative Office	Horsholm
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Italy	Sanofi-Aventis Administrative Office	Milano
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Poland	Sanofi-Aventis Administrative Office	Warszawa
South Africa	Sanofi-Aventis Administrative Office	Midrand

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Argentina,  Australia,  Belgium,  Chile,  Denmark,  France,  Germany,  Italy,  Netherlands,  Poland,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Plasma Glucose (MPG) from baseline to week 4.
Secondary	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

External Links

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