Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects
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The purpose of this 32 week study is to demonstrate that fixed-dose combination treatment with rosiglitazone/metformin 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 rosiglitazone/metformin compared to its rosiglitazone and metformin.
A Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Fixed Dose Rosiglitazone/Metformin Combination Therapy Compared to Both Rosiglitazone and Metformin Monotherapies in Drug Naive Type 2 Diabetes Mellitus Subjects
Study Start Date :
October 8, 2003
Actual Primary Completion Date :
December 1, 2004
Actual Study Completion Date :
December 16, 2004
Resource links provided by the National Library of Medicine
Change from baseline in hemoglobin A1c (HbA1c) at week 32. [ Time Frame: at 32 week ]
Secondary Outcome Measures :
Key Secondary Measures: Change in FPG HbA1c and FPG responders Change in insulin, C-peptide, free fatty acids, lipids, insulin sensitivity and beta cell function Adverse Events Vital Signs Weight 32 weeks [ Time Frame: at 32 weeksInvalid value ]
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
18 to 70 years of age
Clinical diagnosis of type 2 diabetes
HbA1c >7.5% to 11%
FPG <270mg/dL (15mmol)
Current treatment with diet and/or exercise alone, or no more than 15 days of an anti-diabetic medication or insulin within 12 weeks of screening
Clinically significant renal or hepatic disease
Presence of anemia
Presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring therapy
Systolic blood pressure >170mmHg or diastolic blood pressure >100mmHg, while on anti-hypertensive treatment
Chronic disease requiring intermittent or chronic treatment with corticosteroids
Any female lactating, pregnant, or planning to become pregnant
History of hepatocellular reaction, severe edema or a medically serious fluid related event associated with any thiazolidinedione
For additional information about this study please refer to the GSK Clinical Study Register
Publications of Results:
Chou H., et. al.; Rosiglitazone and metformin fixed-dose combination provides superior glycaemic control compared to metformin and rosiglitazone monotherapies, and was well tolerated in drug-naïve patients with T2DM [poster]; European Association for the Study of Diabetes, 10-15 September 2005, Athens, Greece.