Rosiglitazone on Microalbuminuria in Type 2 Diabetics

NCT ID: NCT00500955

Last Updated: 2016-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2004-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Rosiglitazone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Birmingham, Alabama, United States

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Tempe, Arizona, United States

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Fullerton, California, United States

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Long Beach, California, United States

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Mission Viejo, California, United States

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Pasadena, California, United States

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Redwood City, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Santa Barbara, California, United States

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Tustin, California, United States

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Ukiah, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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New Britain, Connecticut, United States

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Norwalk, Connecticut, United States

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Newark, Delaware, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Winter Park, Florida, United States

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Blue Ridge, Georgia, United States

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Chicago, Illinois, United States

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Peoria, Illinois, United States

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Indianapolis, Indiana, United States

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South Bend, Indiana, United States

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Slidell, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Royal Oak, Michigan, United States

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Brooklyn Center, Minnesota, United States

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St Louis, Missouri, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Binghamton, New York, United States

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Endwell, New York, United States

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New York, New York, United States

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Portland, Oregon, United States

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Hermitage, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Columbia, South Carolina, United States

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Beaumont, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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Edmonds, Washington, United States

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Spokane, Washington, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Vienna, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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North Bay, Ontario, Canada

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Ottawa, Ontario, Canada

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Peterborough, Ontario, Canada

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Smiths Falls, Ontario, Canada

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Toronto, Ontario, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Viña del Mar, Región de Valparaíso, Chile

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Santiago, Región Metro de Santiago, Chile

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Santiago, Región Metro de Santiago, Chile

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Königsfeld im Schwarzwald, Baden-Wurttemberg, Germany

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Unterschneidheim, Baden-Wurttemberg, Germany

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Grafing, Bavaria, Germany

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Frankfurt am Main, Hesse, Germany

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Borna, Saxony, Germany

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Delitzsch, Saxony, Germany

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Dresden, Saxony, Germany

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Görlitz, Saxony, Germany

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Leipzig, Saxony, Germany

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Apolda, Thuringia, Germany

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Jelgava, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Talsi, , Latvia

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Valmiera, , Latvia

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Durango, Durango, Mexico

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Guadalajara, Jalisco, Mexico

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México, , Mexico

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Amersfoort, , Netherlands

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Leiden, , Netherlands

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Rotterdam, , Netherlands

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Zwaag, , Netherlands

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Banská Bystrica, , Slovakia

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Bratislava, , Slovakia

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Martin, , Slovakia

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Alicante, , Spain

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Granada, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Sagunto/Valencia, , Spain

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Santiago de Compostela, , Spain

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Liverpool, Merseyside, United Kingdom

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Edinburgh, Midlothian, United Kingdom

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Paisley, Renfrewshire, United Kingdom

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Bath, Somerset, United Kingdom

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Livingston, West Lothian, United Kingdom

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Gateshead, , United Kingdom

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Newport, , United Kingdom

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Countries

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United States Austria Canada Chile Germany Latvia Mexico Netherlands Slovakia Spain United Kingdom

References

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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.

Reference Type 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.

Reference Type RESULT

Study Documents

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Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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BRL-49653/137

Identifier Type: -

Identifier Source: org_study_id

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