Efficacy and Safety In Poorly Controlled Type 2 Diabetics
The purpose of this study is to gain safety and efficacy information in patients with type 2 diabetes, who have not previously taken any oral antidiabetic medications, and who have an HbA1c value of greater than or equal to 10%, despite diet and exercise.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A 24-week Randomized, Double-Blind, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Dosing Regimens, 4mg OD and 8mg OD, in Poorly-Controlled Drug Naive Patients With Type 2 Diabetes Mellitus|
- Change in HbA1c from baseline to Week 24.
- Change in FPG (fasting plasma glucose) from baseline to Week 24; characterize the effects of rosiglitazone on the albumin-creatinine ratio at Week 24.
|Study Start Date:||May 2002|
|Study Completion Date:||April 2003|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
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|Study Director:||GSK Clinical Trial, MD, PhD||GlaxoSmithKline|