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

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00499707

Run by

GlaxoSmithKline

People needed

453

Starts

2003-10-08

Expected to finish

2004-12-16

Last updated by the study team

2018-03-21

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Chandler, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Encinitas, California, United States
• GSK Investigational Site — Fullerton, California, United States
• GSK Investigational Site — Los Banos, California, United States
• GSK Investigational Site — Mission Viejo, California, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Melbourne, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Saint Cloud, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Fayetteville, Georgia, United States
• GSK Investigational Site — Woodstock, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Evansville, Indiana, United States
• GSK Investigational Site — Newburgh, Indiana, United States
• GSK Investigational Site — Slidell, Louisiana, United States
• GSK Investigational Site — Jackson, Mississippi, United States
• GSK Investigational Site — Chesterfield, Missouri, United States
• GSK Investigational Site — Kansas City, Missouri, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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