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

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00754689
• Other study ID #: EFC10231
• Secondary ID: EudraCT 2008-002
• Status: Terminated
• Phase: Phase 3
• First received: September 17, 2008
• Last updated: November 7, 2008
• Start date: September 2008
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 750
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• rimonabant (SR141716)
oral administration
• metformin
oral administration
• placebo
oral administration

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in A1C		at 9 months	No
Secondary	Change from baseline in fasting plasma glucose		at 9 months	No
Secondary	Change from baseline in body weight		at 9 months	No
Secondary	Percent change from baseline in TG		at 9 months	No
Secondary	Percent change from baseline in HDL-C		at 9 months	No

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