Rosiglitazone on Microalbuminuria in Type 2 Diabetics

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

Following a 4-week single-blind placebo run-in period, eligible subjects were randomized in a 1:1 ratio to receive 32 weeks of double-blind study medication: Rosiglitazone (starting dose 4mg od) or Glyburide (starting dose 5mg od), both in combination with open-label Metformin \> or = (1g/day). Subjects were stratified for use of ACEI, nondihydropyridine calcium channel blockers (NDP CCB), or angiotensin II receptor blockers (ARB) to provide equal representation of these subjects in each treatment group.

Key facts

Study ID

NCT00500955

Run by

GlaxoSmithKline

People needed

336

Starts

2000-04-01

Expected to finish

2004-06-01

Last updated by the study team

2016-09-15

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects, aged 40-80 with T2DM and Microalbuminuria previously treated by diet and exercise alone, a single oral antidiabetic agent, or combination oral antidiabetic therapy.

You may not qualify if…

• Pregnancy or lactation, use of any TZD (pioglitazone or Rosiglitazone) or insulin, renal disease or renal dysfunction , any degree of congestive heart failure, clinically significant hepatic disease or anemia, presence of unstable or severe angina or coronary insufficiency, high blood pressure

Where it is running

• GSK Investigational Site — Tempe, Arizona, United States
• GSK Investigational Site — Fullerton, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Mission Viejo, California, United States
• GSK Investigational Site — Pasadena, California, United States
• GSK Investigational Site — Redwood City, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Santa Barbara, California, United States
• GSK Investigational Site — Tustin, California, United States
• GSK Investigational Site — Ukiah, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — New Britain, Connecticut, United States
• GSK Investigational Site — Norwalk, Connecticut, United States
• GSK Investigational Site — Newark, Delaware, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Winter Park, Florida, United States
• GSK Investigational Site — Blue Ridge, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Peoria, Illinois, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — South Bend, Indiana, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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