Study of Rimonabant/Metformin Combinations to Investigate Diabetes (Blood Sugar) Control in Patients With Type 2 Diabetes

NCT ID: NCT00754689

Last Updated: 2016-05-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2008-11-30

Brief Summary

The primary objective of the study is to demonstrate superiority of rimonabant/metformin combinations in Glycosylated Hemoglobin 1c (A1C) reduction over the corresponding single agent metformin and over rimonabant alone in patients with type 2 diabetes mellitus at 9 months.

The secondary objective is to investigate the effects of rimonabant/metformin combinations for reducing fasted plasma glucose, body weight and triglycerides, and raising High Density Lipoprotein Cholesterol (HDL-C) in comparison with metformin at 9 months.

Another objective is to evaluate the safety of rimonabant in combination with metformin over a period of up to 52 weeks.

Detailed Description

The duration per patient is up to 65 weeks: 1 - 2 weeks screening, up to 52 weeks double blind treatment, and 75 days post last dose. This study will end for all patients when the last patient has been treated for at least 9 months.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

Metformin 500mg twice daily (bid) + placebo

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Tablet, oral administration

placebo

Intervention Type: DRUG

Tablet, oral administration

Arm 2

Metformin 1000mg bid + placebo

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Tablet, oral administration

placebo

Intervention Type: DRUG

Tablet, oral administration

Arm 3

Rimonabant 20mg once daily (od) + placebo

Group Type: ACTIVE_COMPARATOR

Rimonabant

Intervention Type: DRUG

Tablet, oral administration

placebo

Intervention Type: DRUG

Tablet, oral administration

Arm 4

Rimonabant 10mg bid (from week 2) in combination with metformin 500mg bid

Group Type: EXPERIMENTAL

Rimonabant

Intervention Type: DRUG

Tablet, oral administration

Metformin

Intervention Type: DRUG

Tablet, oral administration

Arm 5

Rimonabant 10mg bid (from week 2) in combination with metformin 1000mg bid

Group Type: EXPERIMENTAL

Rimonabant

Intervention Type: DRUG

Tablet, oral administration

Metformin

Intervention Type: DRUG

Tablet, oral administration

Interventions

Rimonabant

Tablet, oral administration

Intervention Type: DRUG

Metformin

Tablet, oral administration

Intervention Type: DRUG

placebo

Tablet, oral administration

Intervention Type: DRUG

Other Intervention Names

SR141716; Acomplia

Eligibility Criteria

Inclusion Criteria

• History of type 2 diabetes mellitus diagnosed prior to the screening visit 1 (ADA criteria)
• Patients must not have used any oral or injectable glucose lowering medication at least 12 weeks prior to the screening visit to establish a stable, comparable baseline A1C assessment in all patients
• A1C ≥7.0 % and ≤10.0 %
• Fasted plasma glucose at screening visit ≤260 mg/dL (14.44 mmol/L)

Exclusion Criteria

• Treatment with any anti-diabetic oral agent, or injectable antidiabetic agent within 12 weeks prior to screening visit
• In the 3 months prior to the screening visit, use of any anti-obesity agent or drugs for weight loss, or administration of systemic corticosteroids for more than 7 days
• Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders
• Presence or history of cancer within the past five years
• Pregnant or breast-feeding women, or women of childbearing potential not protected by effective method of birth control

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Countries

United States

Other Identifiers

2008-002500-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC10231

Identifier Type: -

Identifier Source: org_study_id