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An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients With Type 2 Diabetes

Sponsor
Sanofi (Industry)
Overall Status
Terminated
CT.gov ID
NCT00577148
Collaborator
(none)
89
Enrollment
24
Locations
2
Arms
12
Duration (Months)
3.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effect of rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH) in patients with Type 2 diabetes.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The total duration per patient will be approximately 22 months including a 18-month double-blind treatment period.

Study Design

Study Type:
Interventional
Actual Enrollment :
89 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Type 2 Diabetic Patients With Nonalcoholic Steatohepatitis (NASH).
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rimonabant

Rimonabant 20 mg once daily.

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

    		•
    Placebo Comparator: Placebo

    Placebo (for Rimonabant) once daily.

    Drug: Placebo (for Rimonabant)
    Tablet, oral administration

    Outcome Measures

    Primary Outcome Measures

    1. Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS) [Baseline to 18 months]

    Secondary Outcome Measures

    1. Change from baseline in hepatic fibrosis score [Baseline to 18 months]

    2. Change from baseline in serum hyaluronate and hepatic transaminases (AST/ALT) [Baseline to 18 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with Type 2 diabetes mellitus and a diagnosis of NASH
    Exclusion Criteria:

    • Excessive alcohol use

    • Presence of Type 1 diabetes mellitus

    • Other chronic liver disease

    • Previous or current hepatocellular carcinoma

    • Use of medication known to cause steatosis

    • Previous bariatric surgery

    • Pregnancy or breastfeeding

    • 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

    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
    2 Sanofi-Aventis Administrative Office Buenos Aires Argentina
    3 Sanofi-Aventis Administrative Office Cove New South Wales Australia
    4 Sanofi-Aventis Administrative Office Diegem Belgium
    5 Sanofi-Aventis Administrative Office Sao Paulo Brazil
    6 Sanofi-Aventis Administrative Office Santiago Chile
    7 Sanofi-Aventis Administrative Office Shangai China
    8 Sanofi-Aventis Administrative Office Santafe de Bogota Colombia
    9 Sanofi-Aventis Administrative Office Zagreb Croatia
    10 Sanofi-Aventis Administrative Office Paris France
    11 Sanofi-Aventis Administrative Office Berlin Germany
    12 Sanofi-Aventis Administrative Office Budapest Hungary
    13 Sanofi-Aventis Administrative Office Milan Italy
    14 Sanofi-Aventis Administrative Office Kuala Lumpur Malaysia
    15 Sanofi-Aventis Administrative Office Mexico Mexico
    16 Sanofi-Aventis Administrative Office Makati City Philippines
    17 Sanofi-Aventis Administrative Office Warszawa Poland
    18 Sanofi-Aventis Administrative Office Porto Salvo Portugal
    19 Sanofi-Aventis Administrative Office Puerto Rico Puerto Rico
    20 Sanofi-Aventis Administrative Office Bucuresti Romania
    21 Sanofi-Aventis Administrative Office Barcelona Spain
    22 Sanofi-Aventis Administrative Office Geneva Switzerland
    23 Sanofi-Aventis Administrative Office Taipei Taiwan
    24 Sanofi-Aventis Administrative Office Guildford Surrey United Kingdom

    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:
    NCT00577148
    Other Study ID Numbers:
    • EFC10144
    • 2007-003013-14
    First Posted:
    Dec 19, 2007
    Last Update Posted:
    May 18, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by Sanofi
    NASH
    chronic liver disease
    Additional relevant MeSH terms:
    Fatty Liver
    Non-alcoholic Fatty Liver Disease
    Rimonabant

    Study Results

    No Results Posted as of May 18, 2016