Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Study to Evaluate the Efficacy of Rosiglitazone (BRL-049653) on Reduction of Microalbuminuria in Subjects With Type 2 Diabetes Mellitus
| Verified date | September 2016 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 336 |
| Est. completion date | June 2004 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | GSK Investigational Site | Vienna | |
| Austria | GSK Investigational Site | Vienna | |
| Austria | GSK Investigational Site | Vienna | |
| Canada | GSK Investigational Site | Laval | Quebec |
| Canada | GSK Investigational Site | Montreal | Quebec |
| Canada | GSK Investigational Site | North Bay | Ontario |
| Canada | GSK Investigational Site | Ottawa | Ontario |
| Canada | GSK Investigational Site | Peterborough | Ontario |
| Canada | GSK Investigational Site | Sainte-Foy | Quebec |
| Canada | GSK Investigational Site | Smiths Falls | Ontario |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Vancouver | British Columbia |
| Canada | GSK Investigational Site | Winnipeg | Manitoba |
| Chile | GSK Investigational Site | Santiago | Región Metro De Santiago |
| Chile | GSK Investigational Site | Santiago | Región Metro De Santiago |
| Chile | GSK Investigational Site | Viña del Mar | Valparaíso |
| Germany | GSK Investigational Site | Apolda | Thueringen |
| Germany | GSK Investigational Site | Borna | Sachsen |
| Germany | GSK Investigational Site | Delitzsch | Sachsen |
| Germany | GSK Investigational Site | Dresden | Sachsen |
| Germany | GSK Investigational Site | Frankfurt | Hessen |
| Germany | GSK Investigational Site | Goerlitz | Sachsen |
| Germany | GSK Investigational Site | Grafing | Bayern |
| Germany | GSK Investigational Site | Koenigsfeld | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Leipzig | Sachsen |
| Germany | GSK Investigational Site | Unterschneidheim | Baden-Wuerttemberg |
| Latvia | GSK Investigational Site | Jelgava | |
| Latvia | GSK Investigational Site | Riga | |
| Latvia | GSK Investigational Site | Riga | |
| Latvia | GSK Investigational Site | Riga | |
| Latvia | GSK Investigational Site | Talsi | |
| Latvia | GSK Investigational Site | Valmiera | |
| Mexico | GSK Investigational Site | Durango | |
| Mexico | GSK Investigational Site | Guadalajara | Jalisco |
| Mexico | GSK Investigational Site | Mexico | |
| Netherlands | GSK Investigational Site | Amersfoort | |
| Netherlands | GSK Investigational Site | Leiden | |
| Netherlands | GSK Investigational Site | Rotterdam | |
| Netherlands | GSK Investigational Site | Zwaag | |
| Slovakia | GSK Investigational Site | Banska Bystrica | |
| Slovakia | GSK Investigational Site | Bratislava | |
| Slovakia | GSK Investigational Site | Martin | |
| Spain | GSK Investigational Site | Alicante | |
| Spain | GSK Investigational Site | Granada | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Sagunto/Valencia | |
| Spain | GSK Investigational Site | Santiago De Compostela | |
| United Kingdom | GSK Investigational Site | Bath | Somerset |
| United Kingdom | GSK Investigational Site | Edinburgh | Midlothian |
| United Kingdom | GSK Investigational Site | Gateshead | |
| United Kingdom | GSK Investigational Site | Liverpool | Merseyside |
| United Kingdom | GSK Investigational Site | Livingston | West Lothian |
| United Kingdom | GSK Investigational Site | Newport | |
| United Kingdom | GSK Investigational Site | Paisley | Renfrewshire |
| United States | GSK Investigational Site | Albany | New York |
| United States | GSK Investigational Site | Albuquerque | New Mexico |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Beaumont | Texas |
| United States | GSK Investigational Site | Binghamton | New York |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Blue Ridge | Georgia |
| United States | GSK Investigational Site | Boston | Massachusetts |
| United States | GSK Investigational Site | Brooklyn Center | Minnesota |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Columbia | South Carolina |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Edmonds | Washington |
| United States | GSK Investigational Site | Endwell | New York |
| United States | GSK Investigational Site | Fullerton | California |
| United States | GSK Investigational Site | Henderson | Nevada |
| United States | GSK Investigational Site | Hermitage | Pennsylvania |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Jacksonville | Florida |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Long Beach | California |
| United States | GSK Investigational Site | Madison | Wisconsin |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Milwaukee | Wisconsin |
| United States | GSK Investigational Site | Mission Viejo | California |
| United States | GSK Investigational Site | New Britain | Connecticut |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | Newark | Delaware |
| United States | GSK Investigational Site | Norwalk | Connecticut |
| United States | GSK Investigational Site | Pasadena | California |
| United States | GSK Investigational Site | Peoria | Illinois |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Redwood City | California |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Royal Oak | Michigan |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| 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 | Slidell | Louisiana |
| United States | GSK Investigational Site | South Bend | Indiana |
| United States | GSK Investigational Site | Spokane | Washington |
| United States | GSK Investigational Site | Springfield | Massachusetts |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | Tempe | Arizona |
| United States | GSK Investigational Site | Tustin | California |
| United States | GSK Investigational Site | Ukiah | California |
| United States | GSK Investigational Site | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Austria, Canada, Chile, Germany, Latvia, Mexico, Netherlands, Slovakia, Spain, United Kingdom,
Bakris GL, Ruilope LM, Weston WM, Porter LE, Huang C, Heise MA, Freed MI. Rosiglitazone (RSG) added to metformin (MET) reduces urinary albumin/creatinine ratio and ambulatory blood pressure in subjects with microalbuminuria and type 2 diabetes (T2DM). Dia
Ruilope LM, Bakris GL, McMorn SO, Weston WM, Huang C, Heise MA, Porter LE, Freed MI. Rosiglitazone added to metformin reduces urinary albumin/creatinine ratio and ambulatory blood pressure in subjects with microalbuminuria and type 2 diabetes. Diabetologi
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary efficacy endpoint was percent change from baseline in ACR after 32 weeks of treatment. | 32 Weeks | ||
| Secondary | 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 |
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