Rosiglitazone on Microalbuminuria in Type 2 Diabetics
A Study to Evaluate the Efficacy of Rosiglitazone (BRL-049653) on Reduction of Microalbuminuria in Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
336
11 countries
113
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Apr 2000
Longer than P75 for phase_3 diabetes-mellitus-type-2
113 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 12, 2007
CompletedFirst Posted
Study publicly available on registry
July 13, 2007
CompletedSeptember 15, 2016
September 1, 2016
July 12, 2007
September 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy endpoint was percent change from baseline in ACR after 32 weeks of treatment.
32 Weeks
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (113)
GSK Investigational Site
Birmingham, Alabama, 35211, United States
GSK Investigational Site
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
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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
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Indianapolis, Indiana, 46201, United States
GSK Investigational Site
South Bend, Indiana, 46601, United States
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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
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Albany, New York, 12206, United States
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Binghamton, New York, 13903, United States
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Endwell, New York, 13760, United States
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New York, New York, 10010, United States
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Portland, Oregon, 97232, United States
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Hermitage, Pennsylvania, 16148, United States
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Philadelphia, Pennsylvania, 19124, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15221, United States
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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
Viña del Mar, Región de Valparaíso, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7510605, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 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
Related Publications (2)
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.
RESULTRuilope 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.
RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2007
First Posted
July 13, 2007
Study Start
April 1, 2000
Study Completion
June 1, 2004
Last Updated
September 15, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.