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

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: rosiglitazone maleate/metformin hydrochloride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, PhD, Study Chair, Affiliation: GlaxoSmithKline

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

Primary outcome: Change from baseline in hemoglobin A1c (HbA1c) at week 32.

Secondary outcome: 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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

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www.diabetes-trial.com

Starting date: October 2003
Last updated: January 28, 2008