Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478972
Status:
TERMINATED
Last Update Posted:
2016-06-08
First Post:
2007-05-24
Brief Title:
Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients on Diet and Exercise
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel-group Fixed Single-dose Regimen Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Type 2 Diabetic Patients Inadequately Controlled With Diet and Exercise Alone
Status:
TERMINATED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company decision taken in light of demands by certain national health authorities
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOLO
Brief Summary:
The primary objective of this study is to assess the efficacy of Rimonabant SR141716 compared to placebo on change in HbA1c and on relative change in body weight over 36 weeks in obese type 2 diabetic patients inadequately controlled with diet and exercise alone
The secondary objectives are
To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control waist circumference Body Mass Index and metabolic parameters
To evaluate the safety and tolerability of Rimonabant compared to placebo
To evaluate the pharmacokinetics of Rimonabant
The secondary objectives are
To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control waist circumference Body Mass Index and metabolic parameters
To evaluate the safety and tolerability of Rimonabant compared to placebo
To evaluate the pharmacokinetics of Rimonabant
Detailed Description:
The total duration per patient will be approximately 53 weeks including a 36-week double-blind treatment period
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