| Trial ID: | L2493 |
| Source ID: | NCT00478972
|
| Associated Drug: |
Rimonabant
|
| Title: |
Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise
|
| Acronym: |
SOLO
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Obesity|Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: Rimonabant|DRUG: placebo (for Rimonabant)|OTHER: Diet and exercise
|
| Outcome Measures: |
Primary: Absolute change from baseline in HbA1C, Baseline to Week 36|Relative change from baseline in body weight, Baseline to Week 36 | Secondary: Absolute change from baseline in Fasting Plasma Glucose, Baseline to Week 36|Absolute change from baseline in waist circumference, Baseline to Week 36|Relative change from baseline in Triglycerides and HDL-cholesterol, Baseline to Week 36|Safety: Overview of adverse events, Baseline to Week 47
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
321
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-04
|
| Completion Date: |
2009-01
|
| Results First Posted: |
|
| Last Update Posted: |
2016-06-08
|
| Locations: |
Sanofi-Aventis Administrative Office, Tokyo, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00478972
|
