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

Sanofi

Status and phase: Withdrawn; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: placebo; Drug: Rimonabant; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00754689

2008-002500-26 (EudraCT Number)

EFC10231

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 5 patient groups

Arm 1

Active Comparator group

Description:

Metformin 500mg twice daily (bid) + placebo

Treatment:

Drug: placebo

Drug: Metformin

Arm 2

Active Comparator group

Description:

Metformin 1000mg bid + placebo

Treatment:

Drug: placebo

Drug: Metformin

Arm 3

Active Comparator group

Description:

Rimonabant 20mg once daily (od) + placebo

Treatment:

Drug: placebo

Drug: Rimonabant

Arm 4

Experimental group

Description:

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

Treatment:

Drug: Metformin

Drug: Rimonabant

Arm 5

Experimental group

Description:

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

Treatment:

Drug: Metformin

Drug: Rimonabant