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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosiglitazone | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint was percent change from baseline in ACR after 32 weeks of treatment. | 32 Weeks |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35211 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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). Diabetes 2005;54(suppl 1):A134. Poster (543-P) presented at 65th Scientific Sessions of the Amercian Diabetes Association, June 10-14, 2005, San Diego, California. | ||
| Result | 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. Diabetologia 2005;48(suppl 1):A283. Poster (779) presented at the 41st Annual Meeting of the European Association for the Study of Diabetes, September 12-15, 2005, Athens, Greece. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| BRL-49653/137 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Tempe |
| Arizona |
| 85282 |
| United States |
| GSK Investigational Site | Fullerton | California | 92835 | United States |
| GSK Investigational Site | Long Beach | California | 90806 | United States |
| GSK Investigational Site | Mission Viejo | California | 92691 | United States |
| GSK Investigational Site | Pasadena | California | 91105 | United States |
| GSK Investigational Site | Redwood City | California | 94062 | United States |
| GSK Investigational Site | San Diego | California | 92108 | United States |
| GSK Investigational Site | San Diego | California | 92128 | United States |
| GSK Investigational Site | Santa Barbara | California | 93105 | United States |
| GSK Investigational Site | Tustin | California | 92780 | United States |
| GSK Investigational Site | Ukiah | California | 95482 | United States |
| GSK Investigational Site | Denver | Colorado | 80209 | United States |
| GSK Investigational Site | Denver | Colorado | 80220 | United States |
| GSK Investigational Site | New Britain | Connecticut | 06050 | United States |
| GSK Investigational Site | Norwalk | Connecticut | 06850 | United States |
| GSK Investigational Site | Newark | Delaware | 19713 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32204 | United States |
| GSK Investigational Site | Miami | Florida | 33136 | United States |
| GSK Investigational Site | Winter Park | Florida | 32789 | United States |
| GSK Investigational Site | Blue Ridge | Georgia | 30513 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Peoria | Illinois | 61615 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46201 | United States |
| GSK Investigational Site | South Bend | Indiana | 46601 | United States |
| GSK Investigational Site | Slidell | Louisiana | 70458 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21208 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02215 | United States |
| GSK Investigational Site | Springfield | Massachusetts | 01199 | United States |
| GSK Investigational Site | Royal Oak | Michigan | 48073 | United States |
| GSK Investigational Site | Brooklyn Center | Minnesota | 55430 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Henderson | Nevada | 89014 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89103 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87106 | United States |
| GSK Investigational Site | Albany | New York | 12206 | United States |
| GSK Investigational Site | Binghamton | New York | 13903 | United States |
| GSK Investigational Site | Endwell | New York | 13760 | United States |
| GSK Investigational Site | New York | New York | 10010 | United States |
| GSK Investigational Site | Portland | Oregon | 97232 | United States |
| GSK Investigational Site | Hermitage | Pennsylvania | 16148 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19124 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15221 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29201 | United States |
| GSK Investigational Site | Beaumont | Texas | 77701 | United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Houston | Texas | 77027 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Houston | Texas | 77074 | United States |
| GSK Investigational Site | San Antonio | Texas | 78207 | United States |
| GSK Investigational Site | San Antonio | Texas | 78237 | United States |
| GSK Investigational Site | Richmond | Virginia | 23249 | United States |
| GSK Investigational Site | Edmonds | Washington | 98026 | United States |
| GSK Investigational Site | Spokane | Washington | 99204 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53792 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53209-0996 | United States |
| GSK Investigational Site | Vienna | A-1030 | Austria |
| GSK Investigational Site | Vienna | A-1090 | Austria |
| GSK Investigational Site | Vienna | A-1140 | Austria |
| GSK Investigational Site | Vancouver | British Columbia | V6Z 2K8 | Canada |
| GSK Investigational Site | Winnipeg | Manitoba | R3A 1R9 | Canada |
| GSK Investigational Site | North Bay | Ontario | P1B 2H3 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1H 7W9 | Canada |
| GSK Investigational Site | Peterborough | Ontario | K9J 7B3 | Canada |
| GSK Investigational Site | Smiths Falls | Ontario | K7A 2H6 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5C 2T2 | Canada |
| GSK Investigational Site | Laval | Quebec | H7T 2P5 | Canada |
| GSK Investigational Site | Montreal | Quebec | H1T 2M4 | Canada |
| GSK Investigational Site | Sainte-Foy | Quebec | G1V 4G2 | Canada |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 7510605 | Chile |
| GSK Investigational Site | Santiago | Región Metro de Santiago | Chile |
| GSK Investigational Site | Viña del Mar | Valparaiso | Chile |
| GSK Investigational Site | Königsfeld im Schwarzwald | Baden-Wurttemberg | 78126 | Germany |
| GSK Investigational Site | Unterschneidheim | Baden-Wurttemberg | 73485 | Germany |
| GSK Investigational Site | Grafing | Bavaria | 85567 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60596 | Germany |
| GSK Investigational Site | Borna | Saxony | 04552 | Germany |
| GSK Investigational Site | Delitzsch | Saxony | 04509 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01307 | Germany |
| GSK Investigational Site | Görlitz | Saxony | 02826 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04107 | Germany |
| GSK Investigational Site | Apolda | Thuringia | 99510 | Germany |
| GSK Investigational Site | Jelgava | LV 3001 | Latvia |
| GSK Investigational Site | Riga | LV 1006 | Latvia |
| GSK Investigational Site | Riga | LV1002 | Latvia |
| GSK Investigational Site | Riga | LV1079 | Latvia |
| GSK Investigational Site | Talsi | LV 3201 | Latvia |
| GSK Investigational Site | Valmiera | LV 4201 | Latvia |
| GSK Investigational Site | Durango | Durango | 3400 | Mexico |
| GSK Investigational Site | Guadalajara | Jalisco | 44340 | Mexico |
| GSK Investigational Site | México | 14080 | Mexico |
| GSK Investigational Site | Amersfoort | 3818 ES | Netherlands |
| GSK Investigational Site | Leiden | 2331 JE | Netherlands |
| GSK Investigational Site | Rotterdam | 3021 HC | Netherlands |
| GSK Investigational Site | Zwaag | 1689 PZ | Netherlands |
| GSK Investigational Site | Banská Bystrica | 975 17 | Slovakia |
| GSK Investigational Site | Bratislava | 813 69 | Slovakia |
| GSK Investigational Site | Martin | 036 59 | Slovakia |
| GSK Investigational Site | Alicante | Spain |
| GSK Investigational Site | Granada | 18003 | Spain |
| GSK Investigational Site | Madrid | 28035 | Spain |
| GSK Investigational Site | Madrid | 28041 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Madrid | 28047 | Spain |
| GSK Investigational Site | Sagunto/Valencia | 46520 | Spain |
| GSK Investigational Site | Santiago de Compostela | 15705 | Spain |
| GSK Investigational Site | Liverpool | Merseyside | L7 8XP | United Kingdom |
| GSK Investigational Site | Edinburgh | Midlothian | EH3 9YW | United Kingdom |
| GSK Investigational Site | Paisley | Renfrewshire | PA2 9PN | United Kingdom |
| GSK Investigational Site | Bath | Somerset | BA1 3NG | United Kingdom |
| GSK Investigational Site | Livingston | West Lothian | EH54 6PP | United Kingdom |
| GSK Investigational Site | Gateshead | NE9 6SX | United Kingdom |
| GSK Investigational Site | Newport | PO30 5TG | United Kingdom |
For additional information about this study please refer to the GSK Clinical Study Register |
| BRL-49653/137 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BRL-49653/137 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BRL-49653/137 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BRL-49653/137 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BRL-49653/137 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077154 | Rosiglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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