Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bridgewater, New Jersey 08807


Purpose:

The primary objective of the study is to demonstrate superiority of rimonabant/metformin combinations in 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 of the study is to investigate the effects of rimonabant/metformin combinations for reducing fasted plasma glucose, body weight and triglycerides, and raising HDL-C in comparison with metformin at 9 months. Another study objective is to evaluate the safety of rimonabant in combination with metformin over a period of up to 52 weeks.


Study summary:

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.


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.


NCT ID:

NCT00754689


Primary Contact:

Study Director
ICD CSD
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.