| Trial ID: | L6063 |
| Source ID: | NCT00325650
|
| Associated Drug: |
Rimonabant
|
| Title: |
Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes
|
| Acronym: |
RAPSODI
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Prediabetic State
|
| Interventions: |
DRUG: Rimonabant|DRUG: Placebo (for Rimonabant)
|
| Outcome Measures: |
Primary: Time of progression to type 2 diabetes, Baseline to 30 months | Secondary: Change from baseline in body weight, Baseline to 30 months|Change from baseline in waist circumference, Baseline to 30 months|Change from baseline in in glucose homeostasis (HbA1C, fasting plasma glucose and fasting insulin), Baseline to 30 months|Change from baseline in glucose and insulin at 2 hour post-glucose load, Baseline to 30 months|Change from baseline in HDL-Cholesterol and triglycerides (TG), Baseline to 30 months
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
2420
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-05
|
| Completion Date: |
2009-03
|
| Results First Posted: |
|
| Last Update Posted: |
2016-05-18
|
| Locations: |
Sanofi-Aventis, Bridgewater, New Jersey, 08807, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00325650
|
