Diabetes Mellitus, Type 2
Conditions
Keywords
microalbuminuria,, Type 2 Diabetes, rosiglitazone,
Brief summary
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.
Interventions
DRUGRosiglitazone
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint was percent change from baseline in ACR after 32 weeks of treatment. | 32 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 32 Weeks |
Countries
Austria, Canada, Chile, Germany, Latvia, Mexico, Netherlands, Slovakia, Spain, United Kingdom, United States
Outcome results
None listed