Clinical trial NCT00754689: Study of Rimonabant/Metformin Combinations to Investigate Diabetes (Blood Sugar) Control in Patients With Type 2 Diabetes
Official title: A Multicenter, Double Blind, Placebo Controlled Randomized Study of the Efficacy and Safety of Two Rimonabant/Metformin Combinations for Reducing A1C in the Treatment of Patients With Type 2 Diabetes Mellitus Who Are Not on Current Drug Therapy.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Rimonabant/metformin combination
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-09-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in A1C
timeFrame: at 9 months
Secondary outcomes:
measure: Change from baseline in fasting plasma glucose
timeFrame: at 9 months
measure: Change from baseline in body weight
timeFrame: at 9 months
measure: Percent change from baseline in triglycerides
timeFrame: at 9 months
measure: Percent change from baseline in HDL-C
timeFrame: at 9 months
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: