| Trial ID: | L2447 |
| Source ID: | NCT00257257
|
| Associated Drug: |
Rimonabant (Sr141716)
|
| Title: |
Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients
|
| Acronym: |
SERENADE
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Rimonabant (SR141716)
|
| Outcome Measures: |
Primary: Absolute change in HbA1C from baseline to Month 6. | Secondary: Fasting glucose, fasting insulin, C-peptide, HOMA analysis, body weight, HDL-cholesterol, triglycerides, blood pressure, safety (physical examination, vital signs, laboratory tests, adverse events).
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
281
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2005-03
|
| Completion Date: |
2006-06
|
| Results First Posted: |
|
| Last Update Posted: |
2009-04-20
|
| Locations: |
Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, 08807, United States|Sanofi-Aventis Administrative Office, Buenos Aires, Argentina|Sanofi-Aventis Administrative Office, Santiago, Chile|Sanofi-Aventis Administrative Office, Berlin, Germany|Sanofi-Aventis Administrative Office, Budapest, Hungary|Sanofi-Aventis Administrative Office, Gouda, Netherlands|Sanofi-Aventis Administrative Office, Warszawa, Poland
|
| URL: |
https://clinicaltrials.gov/show/NCT00257257
|
