Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT00449605
Status:
TERMINATED
Last Update Posted:
2016-05-16
First Post:
2007-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess Glycemic Control With Rimonabant in Comparison With Glimepiride Over 1 Year in Overweight/Obese Type2 Diabetic Patients Not Adequately Controlled With Metformin
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:
ALLEGRO
Brief Summary:
The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months.
The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.
The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.
Detailed Description:
The total duration per patient will be approximately 65 weeks including a 52-week double-blind treatment period.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2006-005385-39 | EUDRACT_NUMBER | None | View |