Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325650
Status:
TERMINATED
Last Update Posted:
2016-05-18
First Post:
2006-05-12
Brief Title:
Rimonabant In Prediabetic Subjects To Delay Onset Of Type 2 Diabetes
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel-Group Multicenter Study to Assess the Efficacy and Safety of Long-term Administration of Rimonabant in the Prevention of Type 2 Diabetes in Patients With Prediabetic Status ie Impaired Fasting Glucose IFG Impaired Glucose Tolerance IGT or Both
Status:
TERMINATED
Status Verified Date:
2016-04
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:
RAPSODI
Brief Summary:
Primary objective
To evaluate the effect of long-term administration of Rimonabant on the time of progression to type 2 diabetes in patients with prediabetes ie Impaired Fasting Glucose IFG or Impaired Glucose Tolerance IGT or both at baseline
Secondary objectives
To assess the effect on weight loss and weight maintenance sustained effect following a washout period effect on other markers of glycemic control fasting glucose fasting-insulin and HbA1c glucose tolerance and insulin responses during oral glucose tolerance tests OGTTs and on other risk factors HDL-Cholesterol TG
To assess the effect on quality of life
To evaluate long term safety and tolerability
To evaluate the effect of long-term administration of Rimonabant on the time of progression to type 2 diabetes in patients with prediabetes ie Impaired Fasting Glucose IFG or Impaired Glucose Tolerance IGT or both at baseline
Secondary objectives
To assess the effect on weight loss and weight maintenance sustained effect following a washout period effect on other markers of glycemic control fasting glucose fasting-insulin and HbA1c glucose tolerance and insulin responses during oral glucose tolerance tests OGTTs and on other risk factors HDL-Cholesterol TG
To assess the effect on quality of life
To evaluate long term safety and tolerability
Detailed Description:
The total duration per patient will be approximately 38 months including a 30-month 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