Diabetes Mellitus, Type 2Phase 3NCT00500955
Rosiglitazone on Microalbuminuria in Type 2 Diabetics
A Phase 3 study testing Rosiglitazone in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 113 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Rosiglitazone
- How many people
- 336 participants
- Where
- 113 sitesin 11 countries
- Study dates
- Apr 2000to Jun 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
113 sites in 11 countries.
113 sites in 11 countries
United States56 sites
GSK Investigational Site
Albany, New York, 12206
GSK Investigational Site
Albuquerque, New Mexico, 87106
GSK Investigational Site
Baltimore, Maryland, 21208
GSK Investigational Site
Beaumont, Texas, 77701
GSK Investigational Site
Binghamton, New York, 13903
GSK Investigational Site
Birmingham, Alabama, 35211
GSK Investigational Site
Blue Ridge, Georgia, 30513
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Brooklyn Center, Minnesota, 55430
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Columbia, South Carolina, 29201
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Denver, Colorado, 80209
GSK Investigational Site
Denver, Colorado, 80220
GSK Investigational Site
Edmonds, Washington, 98026
GSK Investigational Site
Endwell, New York, 13760
GSK Investigational Site
Fullerton, California, 92835
GSK Investigational Site
Henderson, Nevada, 89014
GSK Investigational Site
Hermitage, Pennsylvania, 16148
GSK Investigational Site
Houston, Texas, 77027
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Houston, Texas, 77074
GSK Investigational Site
Indianapolis, Indiana, 46201
GSK Investigational Site
Jacksonville, Florida, 32204
GSK Investigational Site
Las Vegas, Nevada, 89103
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
Milwaukee, Wisconsin, 53209-0996
GSK Investigational Site
Mission Viejo, California, 92691
GSK Investigational Site
New Britain, Connecticut, 06050
GSK Investigational Site
New York, New York, 10010
GSK Investigational Site
Newark, Delaware, 19713
GSK Investigational Site
Norwalk, Connecticut, 06850
GSK Investigational Site
Pasadena, California, 91105
GSK Investigational Site
Peoria, Illinois, 61615
GSK Investigational Site
Philadelphia, Pennsylvania, 19124
GSK Investigational Site
Pittsburgh, Pennsylvania, 15221
GSK Investigational Site
Portland, Oregon, 97232
GSK Investigational Site
Redwood City, California, 94062
GSK Investigational Site
Richmond, Virginia, 23249
GSK Investigational Site
Royal Oak, Michigan, 48073
GSK Investigational Site
San Antonio, Texas, 78207
GSK Investigational Site
San Antonio, Texas, 78237
GSK Investigational Site
San Diego, California, 92108
GSK Investigational Site
San Diego, California, 92128
GSK Investigational Site
Santa Barbara, California, 93105
GSK Investigational Site
Slidell, Louisiana, 70458
GSK Investigational Site
South Bend, Indiana, 46601
GSK Investigational Site
Spokane, Washington, 99204
GSK Investigational Site
Springfield, Massachusetts, 01199
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Tempe, Arizona, 85282
GSK Investigational Site
Tustin, California, 92780
GSK Investigational Site
Ukiah, California, 95482
GSK Investigational Site
Winter Park, Florida, 32789
Canada10 sites
GSK Investigational Site
Laval, Quebec, H7T 2P5
GSK Investigational Site
Montreal, Quebec, H1T 2M4
GSK Investigational Site
North Bay, Ontario, P1B 2H3
GSK Investigational Site
Ottawa, Ontario, K1H 7W9
GSK Investigational Site
Peterborough, Ontario, K9J 7B3
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G2
GSK Investigational Site
Smiths Falls, Ontario, K7A 2H6
GSK Investigational Site
Toronto, Ontario, M5C 2T2
GSK Investigational Site
Vancouver, British Columbia, V6Z 2K8
GSK Investigational Site
Winnipeg, Manitoba, R3A 1R9
Germany10 sites
GSK Investigational Site
Apolda, Thuringia, 99510
GSK Investigational Site
Borna, Saxony, 04552
GSK Investigational Site
Delitzsch, Saxony, 04509
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Görlitz, Saxony, 02826
GSK Investigational Site
Grafing, Bavaria, 85567
GSK Investigational Site
Königsfeld im Schwarzwald, Baden-Wurttemberg, 78126
GSK Investigational Site
Leipzig, Saxony, 04107
GSK Investigational Site
Unterschneidheim, Baden-Wurttemberg, 73485
Spain8 sites
GSK Investigational Site
Alicante
GSK Investigational Site
Granada, 18003
GSK Investigational Site
Madrid, 28035
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Madrid, 28047
GSK Investigational Site
Sagunto/Valencia, 46520
GSK Investigational Site
Santiago de Compostela, 15705
United Kingdom7 sites
GSK Investigational Site
Bath, Somerset, BA1 3NG
GSK Investigational Site
Edinburgh, Midlothian, EH3 9YW
GSK Investigational Site
Gateshead, NE9 6SX
GSK Investigational Site
Liverpool, Merseyside, L7 8XP
GSK Investigational Site
Livingston, West Lothian, EH54 6PP
GSK Investigational Site
Newport, PO30 5TG
GSK Investigational Site
Paisley, Renfrewshire, PA2 9PN
Latvia6 sites
GSK Investigational Site
Jelgava, LV 3001
GSK Investigational Site
Riga, LV 1006
GSK Investigational Site
Riga, LV1002
GSK Investigational Site
Riga, LV1079
GSK Investigational Site
Talsi, LV 3201
GSK Investigational Site
Valmiera, LV 4201
Netherlands4 sites
GSK Investigational Site
Amersfoort, 3818 ES
GSK Investigational Site
Leiden, 2331 JE
GSK Investigational Site
Rotterdam, 3021 HC
GSK Investigational Site
Zwaag, 1689 PZ
Austria3 sites
GSK Investigational Site
Vienna, A-1030
GSK Investigational Site
Vienna, A-1090
GSK Investigational Site
Vienna, A-1140
Chile3 sites
GSK Investigational Site
Santiago, Región Metro de Santiago, 7510605
GSK Investigational Site
Santiago, Región Metro de Santiago
GSK Investigational Site
Viña del Mar, Valparaiso
Mexico3 sites
GSK Investigational Site
Durango, Durango, 3400
GSK Investigational Site
Guadalajara, Jalisco, 44340
GSK Investigational Site
México, 14080
Slovakia3 sites
GSK Investigational Site
Banská Bystrica, 975 17
GSK Investigational Site
Bratislava, 813 69
GSK Investigational Site
Martin, 036 59
About this study
Official title: A Study to Evaluate the Efficacy of Rosiglitazone (BRL-049653) on Reduction of Microalbuminuria in Subjects With Type 2 Diabetes Mellitus
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Rosiglitazone
- Keywords
- microalbuminuria,, Type 2 Diabetes, rosiglitazone,
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint was percent change from baseline in ACR after 32 weeks of treatment.
Measured: 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
Measured: 32 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startApr 2000
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 336 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500955
- Sponsor's protocol ID
- BRL-49653/137
- Status last verified
- Sep 2016
- First submitted
- 12 Jul 2007
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy of Rosiglitazone (BRL-049653) on Reduction of Microalbuminuria in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00500955
- Acronym / sponsor ID
- BRL-49653/137
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- microalbuminuria,, Type 2 Diabetes, rosiglitazone,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2000
- Study completion
- Jun 2004 (actual)
- First posted
- 13 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosiglitazone | Drug | – |
Primary outcome
The primary efficacy endpoint was percent change from baseline in ACR after 32 weeks of treatment.
Time frame: 32 Weeks
1 secondary outcome
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
Time frame: 32 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Results publicationBakris 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.
- Results publicationRuilope 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
113 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosiglitazone in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 113 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 113 sites in United States, Canada, Germany, Spain, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy endpoint was percent change from baseline in ACR after 32 weeks of treatment. (time frame: 32 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00500955, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.