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

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00754689

Run by

Sanofi

People needed

0

Starts

2008-09-01

Expected to finish

2008-11-01

Last updated by the study team

2016-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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