Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499707
Status:
COMPLETED
Last Update Posted:
2018-03-21
First Post:
2007-07-09
Brief Title:
Efficacy and Safety Study of RosiglitazoneMetformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Double-blind Trial to Evaluate the Efficacy and Safety of Fixed Dose RosiglitazoneMetformin Combination Therapy Compared to Both Rosiglitazone and Metformin Monotherapies in Drug Naive Type 2 Diabetes Mellitus Subjects
Status:
COMPLETED
Status Verified Date:
2018-03
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 purpose of this 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazonemetformin will safely and effectively control glycemia as first line oral therapy in subjects type 2 diabetes The primary objective of the study is to demonstrate superiority of rosiglitazonemetformin compared to its rosiglitazone and metformin
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