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

• Status: Completed
• Trial end date: 2004-12-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Maleic acid; Metformin; Rosiglitazone

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