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Rosiglitazone on Microalbuminuria in Type 2 Diabetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00500955
First received: July 12, 2007
Last updated: September 13, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Rosiglitazone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Efficacy of Rosiglitazone (BRL-049653) on Reduction of Microalbuminuria in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The primary efficacy endpoint was percent change from baseline in ACR after 32 weeks of treatment. [ Time Frame: 32 Weeks ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 336
Study Start Date: April 2000
Study Completion Date: June 2004
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500955

  Show 113 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
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 Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: BRL-49653/137
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: BRL-49653/137
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: BRL-49653/137
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: BRL-49653/137
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: BRL-49653/137
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: BRL-49653/137
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00500955     History of Changes
Other Study ID Numbers: BRL-49653/137 
Study First Received: July 12, 2007
Last Updated: September 13, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
microalbuminuria,
Type 2 Diabetes
rosiglitazone,

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016