Last updated: 11/07/2018 15:59:51
Rosiglitazone on Microalbuminuria in Type 2 Diabetics
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Study to Evaluate the Efficacy of Rosiglitazone (BRL-049653) on Reduction of Microalbuminuria in Subjects with Type 2 Diabetes Mellitus
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
The primary efficacy endpoint was percent change from baseline in ACR after 32 weeks of treatment.
Timeframe: 32 Weeks
Secondary outcomes:
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
Timeframe: 32 Weeks
Interventions:
Enrollment:
336
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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.
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.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
April 2000 to June 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
- 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.
- 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
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Winter Park, Florida, United States, 32789
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80220
Status
Study Complete
Location
GSK Investigational Site
Hermitage, Pennsylvania, United States, 16148
Status
Study Complete
Location
GSK Investigational Site
Endwell, New York, United States, 13760
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87106
Status
Study Complete
Location
GSK Investigational Site
Norwalk, Connecticut, United States, 06850
Status
Study Complete
Location
GSK Investigational Site
New Britain, Connecticut, United States, 06050
Status
Study Complete
Location
GSK Investigational Site
Royal Oak, Michigan, United States, 48073
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
Location
GSK Investigational Site
AMERSFOORT, Netherlands, 3818 ES
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Denver, Colorado, United States, 80209
Status
Study Complete
Location
GSK Investigational Site
Paisley, Renfrewshire, United Kingdom, PA2 9PN
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92128
Status
Study Complete
Location
GSK Investigational Site
Slidell, Louisiana, United States, 70458
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15221
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78207
Status
Study Complete
Location
GSK Investigational Site
Smiths Falls, Ontario, Canada, K7A 2H6
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Location
GSK Investigational Site
South Bend, Indiana, United States, 46601
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35211
Status
Study Complete
Location
GSK Investigational Site
Edmonds, Washington, United States, 98026
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32204
Status
Study Complete
Location
GSK Investigational Site
Newark, Delaware, United States, 19713
Status
Study Complete
Location
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom, EH3 9YW
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Santa Barbara, California, United States, 93105
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
Status
Study Complete
Location
GSK Investigational Site
Mission Viejo, California, United States, 92691
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46201
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10010
Status
Study Complete
Location
GSK Investigational Site
Ukiah, California, United States, 95482
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78237
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97232
Status
Study Complete
Location
GSK Investigational Site
Liverpool, Merseyside, United Kingdom, L7 8XP
Status
Study Complete
Location
GSK Investigational Site
Pasadena, California, United States, 91105
Status
Study Complete
Location
GSK Investigational Site
Bath, Somerset, United Kingdom, BA1 3NG
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
Location
GSK Investigational Site
Blue Ridge, Georgia, United States, 30513
Status
Study Complete
Location
GSK Investigational Site
Springfield, Massachusetts, United States, 01199
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 2K8
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
Status
Study Complete
Location
GSK Investigational Site
Fullerton, California, United States, 92835
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21208
Status
Study Complete
Location
GSK Investigational Site
Peoria, Illinois, United States, 61615
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23249
Status
Study Complete
Location
GSK Investigational Site
Tustin, California, United States, 92780
Status
Study Complete
Location
GSK Investigational Site
Brooklyn Center, Minnesota, United States, 55430
Status
Study Complete
Location
GSK Investigational Site
Henderson, Nevada, United States, 89014
Status
Study Complete
Location
GSK Investigational Site
Unterschneidheim, Baden-Wuerttemberg, Germany, 73485
Status
Study Complete
Location
GSK Investigational Site
Koenigsfeld, Baden-Wuerttemberg, Germany, 78126
Status
Study Complete
Location
GSK Investigational Site
Peterborough, Ontario, Canada, K9J 7B3
Status
Study Complete
Location
GSK Investigational Site
Redwood City, California, United States, 94062
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Albany, New York, United States, 12206
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02215
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92108
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53209-0996
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19124
Status
Study Complete
Location
GSK Investigational Site
Binghamton, New York, United States, 13903
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
Livingston, West Lothian, United Kingdom, EH54 6PP
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2004-09-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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