Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes
NCT ID: NCT00690456
Last Updated: 2016-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
403 participants
INTERVENTIONAL
2008-05-31
2009-02-28
Brief Summary
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Secondary objectives include evaluation of other markers of glycemic control, lipid profile, body weight, and abdominal obesity. Also, the trial will study the safety of rimonabant when added to metformin over a period of 47 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rimonabant
Rimonabant 20 mg once daily on top of metformin
Rimonabant
Tablet, oral administration
Metformin
Metformin continued at stable dose as background therapy
Placebo
Placebo (for Rimonabant) once daily on top of metformin
Placebo (for Rimonabant)
Tablet, oral administration
Metformin
Metformin continued at stable dose as background therapy
Interventions
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Rimonabant
Tablet, oral administration
Placebo (for Rimonabant)
Tablet, oral administration
Metformin
Metformin continued at stable dose as background therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c between 7% to 10% at screening visit
* Treatment with metformin only with a fixed and stable dose of 1500 mg/day or more for at least the past 3 months prior to screening visit
Exclusion Criteria
* Weight loss of more than 5 kg within 3 months prior to screening
* Administration of other investigational drugs within 30 days prior to screening visit
* Prior exposure to type 1 cannabinoid receptor (CB1) antagonists including rimonabant
* Presence or history of cancer within the past five years
* Pregnant or breast-feeding women
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Jakarta, , Indonesia
Sanofi-Aventis Administrative Office
Vilnius, , Lithuania
Sanofi-Aventis Administrative Office
Kuala Lumpur, , Malaysia
Sanofi-Aventis Administrative Office
México, , Mexico
Sanofi-Aventis Administrative Office
Makati City, , Philippines
Sanofi-Aventis Administrative Office
Warsaw, , Poland
Sanofi-Aventis Administrative Office
Bucharest, , Romania
Sanofi-Aventis Administrative Office
Moscow, , Russia
Sanofi-Aventis Administrative Office
Brastislava, , Slovakia
Sanofi-Aventis Administrative Office
Taipei, , Taiwan
Sanofi-Aventis Administrative Office
Bangkok, , Thailand
Sanofi-Aventis Administrative Office
Kiev, , Ukraine
Countries
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Other Identifiers
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2007-004833-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EFC10518
Identifier Type: -
Identifier Source: org_study_id
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