Efficacy and Safety Study of Rosiglitazone/Metformin Therapy vs Rosiglitazone and Metformin in Type 2 Diabetes Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: rosiglitazone maleate/metformin hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rosiglitazone maleate/metformin hydrochloride|rosiglitazone maleate/metformin hydrochloride|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in hemoglobin A1c (HbA1c) at week 32. |  | at 32 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | at 32 weeksInvalid value | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HbA1c, Drug-naive, type 2 diabetes