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

Sponsor
Sanofi (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00754689
Collaborator
(none)
0
Enrollment
1
Location
5
Arms
2
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Sep 1, 2008
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm 1

Metformin 500mg twice daily (bid) + placebo

Drug: Metformin
Tablet, oral administration

Drug: placebo
Tablet, oral administration
Active Comparator: Arm 2

Metformin 1000mg bid + placebo

Drug: Metformin
Tablet, oral administration

Drug: placebo
Tablet, oral administration
Active Comparator: Arm 3

Rimonabant 20mg once daily (od) + placebo

Drug: Rimonabant
Tablet, oral administration
Other Names:
  • SR141716
  • Acomplia

    • Drug: placebo
    Tablet, oral administration
    Experimental: Arm 4

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

    Drug: Rimonabant
    Tablet, oral administration
    Other Names:
  • SR141716
  • Acomplia

    • Drug: Metformin
    Tablet, oral administration
    Experimental: Arm 5

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

    Drug: Rimonabant
    Tablet, oral administration
    Other Names:
  • SR141716
  • Acomplia

    • Drug: Metformin
    Tablet, oral administration

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in A1C [at 9 months]

    Secondary Outcome Measures

    1. Change from baseline in fasting plasma glucose [at 9 months]

    2. Change from baseline in body weight [at 9 months]

    3. Percent change from baseline in triglycerides [at 9 months]

    4. Percent change from baseline in HDL-C [at 9 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sanofi-Aventis Administrative Office Bridgewater New Jersey United States 08807

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: ICD CSD, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT00754689
    Other Study ID Numbers:
    • EFC10231
    • 2008-002500-26
    First Posted:
    Sep 18, 2008
    Last Update Posted:
    May 17, 2016
    Last Verified:
    May 1, 2016
    Keywords provided by Sanofi
    Rimonabant/metformin combination
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Metformin
    Rimonabant

    Study Results

    No Results Posted as of May 17, 2016