Clinical Trial Details
| Trial ID: | L6297 |
| Source ID: | NCT00690456 |
| Associated Drug: | Rimonabant |
| Title: | Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes |
| Acronym: | TOCCATA |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Rimonabant|DRUG: Placebo (for Rimonabant)|DRUG: Metformin |
| Outcome Measures: | Primary: Change from baseline in HbA1c, 36 weeks | Secondary: Change from baseline in fasting plasma glucose, 36 weeks|Change from baseline in body weight, 36 weeks|Percent change from baseline in HDL-C and Triglycerides, 36 weeks |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 403 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2008-05 |
| Completion Date: | 2009-02 |
| Results First Posted: | |
| Last Update Posted: | 2016-05-18 |
| Locations: | Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, 08807, 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, Mexico, Mexico|Sanofi-Aventis Administrative Office, Makati City, Philippines|Sanofi-Aventis Administrative Office, Warszawa, Poland|Sanofi-Aventis Administrative Office, Bucuresti, Romania|Sanofi-Aventis Administrative Office, Moscow, Russian Federation|Sanofi-Aventis Administrative Office, Brastislava, Slovakia|Sanofi-Aventis Administrative Office, Taipei, Taiwan|Sanofi-Aventis Administrative Office, Bangkok, Thailand|Sanofi-Aventis Administrative Office, Kiev, Ukraine |
| URL: | https://clinicaltrials.gov/show/NCT00690456 |
