AVANDAMET Versus Metformin For Type 2 Diabetes Mellitus
This study has been completed.
Information provided by (Responsible Party):
First received: October 17, 2005
Last updated: July 11, 2013
Last verified: July 2012
This 48-week study will compare AVANDAMET vs. Metformin monotherapy for blood glucose control in patients with Type 2 Diabetes Mellitus.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||AVANDAMET Compared to Metformin Evaluation Trial (ACME): A 48-week Randomized, Open-label, Multicenter Study to Compare the Efficacy and Tolerability of AVANDAMET to Metformin Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Control on Submaximal Metformin.|
Resource links provided by NLM:
Drug Information available for: Metformin Metformin hydrochloride Rosiglitazone Rosiglitazone Maleate Rosiglitazone-metformin combinationU.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Change from baseline in HbA1c at week 48.
Secondary Outcome Measures:
- Change from baseline in FPG at week 48. Time to glycemic control. Change from baseline in C-peptide and insulin at week 48.
|Study Start Date:||June 2003|
|Study Completion Date:||December 2005|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
Other Name: rosiglitazone/metformin
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