Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328172
Status:
COMPLETED
Last Update Posted:
2014-03-14
First Post:
2006-05-18
Brief Title:
Efficacy and Safety of 3 Doses of BI1356 Linagliptin in Type 2 Diabetes Patients
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Five Parallel Group Study Investigating the Efficacy and Safety of BI 1356 BS 05 mg 25 mg and 50 mg Administered Orally Once Daily Over 12 Weeks in Drug Naive and Treated Patients With Type 2 Diabetes With Insufficient Glycemic Control Study Includes an Open-label Metformin Treatment Arm
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the current study is to investigate the efficacy safety and tolerability of several doses of BI 1356 BS 05 25 and 5 mg daily compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control In addition there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population Population pharmacokinetics of BI 1356 BS will also be assessed 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