Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00309608
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2006-03-31
Brief Title:
Efficacy and Safety of BI 1356 BS Linagliptin in Combination With Metformin in Patients With type2 Diabetes
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Five Parallel Groups Study Investigating the Efficacy and Safety of BI 1356 BS 1 mg 5 mg and 10 mg Administered Orally Once Daily Over 12 Weeks as add-on Therapy in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Metformin Therapy Including an Open-label Glimepiride Treatment Arm
Status:
COMPLETED
Status Verified Date:
2013-12
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:
None
Brief Summary:
The objective of the study is to test the efficacy safety and tolerability of several doses of BI 1356 BS 1 5 or 10 mg taken once daily compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels In addition there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison The influence of several factors gender age weight race etc on the bioavailability and efficacy of BI 1356 BS will also be tested in this study
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-004597-24 | EUDRACT_NUMBER | EudraCT | None |