Rosiglitazone on Microalbuminuria in Type 2 Diabetics - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00500955

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
Type 2 Diabetes Mellitus Microalbuminuria	Drug: Rosiglitazone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

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

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
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

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

Show 100 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD, Ph.D.

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	BRL-49653/137
Study First Received:	July 12, 2007
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00500955 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

rosiglitazone,
microalbuminuria,
Type 2 Diabetes

Additional relevant MeSH terms:

Albuminuria
Metabolic Diseases
Urination Disorders
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Pharmacologic Actions
Urological Manifestations

Signs and Symptoms
Proteinuria
Hypoglycemic Agents
Urologic Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Rosiglitazone

ClinicalTrials.gov processed this record on February 08, 2010