Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501020
Status:
COMPLETED
Last Update Posted:
2017-10-09
First Post:
2007-07-12
Brief Title:
Comparison of the Efficacy and Tolerability of the Addition of AVANDIA to Submaximal Doses of Metformin
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A 24-Week Randomized Double-blind Double-Dummy Multicenter Study to Compare the Efficacy of AVANDIA When Added to Submaximal Doses of Metformin and to Compare the Tolerability of the Combination to Metformin Monotherapy When Administered to Subjects With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2017-10
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:
This was a randomized double-blind double dummy multicenter study to assess the safety efficacy and tolerability of the addition of RSG rosiglitazone to sub-maximal MET metformin combination relative to maximal MET monotherapy in subjects with type 2 DM diabetes mellitus The total duration of the study was approximately 20 months The study consisted of a two-week washout period a four to seven-week MET titration period and a 24-week randomized treatment phase in which subjects stratified by prior therapy received either RSG MET combination therapy or MET monotherapy
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