Rosiglitazone on Microalbuminuria in Type 2 Diabetics

Condition(s) targeted: Type 2 Diabetes Mellitus; Microalbuminuria

Intervention: Rosiglitazone (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK ClinicalTrials, MD, Ph.D., Study Director, Affiliation: GlaxoSmithKline

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.

Official title: A Study to Evaluate the Efficacy of Rosiglitazone (BRL-049653) on Reduction of Microalbuminuria in Subjects With Type 2 Diabetes Mellitus

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

Primary outcome: The primary efficacy endpoint was percent change from baseline in ACR after 32 weeks of treatment.

Secondary outcome: Secondary efficacy endpoints included change from baseline (visit 3) at week 32 (visit 7) in the following: serum TGF, creatinine clearance (calculated), PAI-1, CRP, IL-6, vWF, sVCAM, fibrinogen, TNF alpha, ET-1, heart rate and blood pressure

Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

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Starting date: April 2000
Last updated: July 12, 2007