Rosiglitazone on Microalbuminuria in Type 2 Diabetics

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Rosiglitazone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00500955

BRL-49653/137

Details and patient eligibility

About

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.

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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