Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-30 @ 6:19 PM
Study NCT ID:
NCT01699932
Status:
COMPLETED
Last Update Posted:
2014-05-08
First Post:
2012-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Multinational, Open Label, Non Comparative, 24-week Study to Evaluate the Blood Glucose Lowering Efficacy and Safety of a Fixed Dose Combination of Glimepiride and Metformin in Patients With Inadequately Controlled Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2014-05
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:
LEGEND
Brief Summary:
Primary Objective:
-To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of HbA1c reduction, during 24-week treatment period in patients with inadequately controlled type 2 diabetes mellitus.
Secondary Objective:
To assess the effects of the fixed combination of glimepiride and metformin at week 24 on:
* Percentage of patients reaching HbA1c \<7%
* Percentage of patients reaching HbA1c \<6.5%.
* Fasting Plasma Glucose (FPG)
* Safety and tolerability
-To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of HbA1c reduction, during 24-week treatment period in patients with inadequately controlled type 2 diabetes mellitus.
Secondary Objective:
To assess the effects of the fixed combination of glimepiride and metformin at week 24 on:
* Percentage of patients reaching HbA1c \<7%
* Percentage of patients reaching HbA1c \<6.5%.
* Fasting Plasma Glucose (FPG)
* Safety and tolerability
Detailed Description:
The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period and 3 days follow-up period with a last call phone visit.
Study Oversight
Has Oversight DMC:
False
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 |
|---|---|---|---|---|
| U1111-1120-0058 | OTHER | UTN | View |