Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257257
Status:
COMPLETED
Last Update Posted:
2009-04-20
First Post:
2005-11-21
Brief Title:
Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel-Group Fixed-Dose Rimonabant 20 mg Multicenter Study of Long-Term Glycemic Control With Rimonabant in Treatment-naïve Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SERENADE
Brief Summary:
Primary Effect on HbA1c over 6 months in drug-naive patients with type 2 diabetes
Secondary Effect on glucose insulin C-peptide insulin resistance body weight HDL-cholesterol triglycerides blood pressure - Safety tolerability
Secondary Effect on glucose insulin C-peptide insulin resistance body weight HDL-cholesterol triglycerides blood pressure - Safety tolerability
Detailed Description:
The total duration of the study will be up to 6 and 12 months including screening period up to 14 days and double-blind treatment period approximately 6 months in patients on mild hypocaloric diet 600 kcalday deficit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None