Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: rosiglitazone maleate/metformin hydrochloride

Primary Measures

• Change from baseline in hemoglobin A1c (HbA1c) at week 32.

Secondary 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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Presence of acute or chronic metabolic acidosis
• History of diabetic ketoacidosis

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD, PhD Study Chair GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00499707

Study ID Number: 712753/007

ClinicalTrials.gov Identifier: NCT00499707

Health Authority: United States: Food and Drug Administration