The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus...
Date First Received: January 17, 2006
Last Updated: May 30, 2007
Verified by: GlaxoSmithKline, May 2007
Clinical Trial Phase: Phase 4 | Start Date: April 2000
Overall Status: Completed
Estimated Enrollment: 4100
Brief Summary
Official Title: “A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus”
Condition Keyword(s):
Intervention(s):
The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Rosiglitazone
- Drug: glyburide
- Drug: metformin
Outcome Measures for this Clinical Trial
Primary Measures
- Time from randomization to the primary action point (monotherapy failure).
Secondary Measures
- Comparison of effects of long-term treatment with Rosiglitazone, Metformin, Glyburide: - maintenance/restoration of beta-cell function: HOMA IS, progression of microalbuminuria, fibrinolytic markers (PAI-1,fibrinogen, CRP).
Criteria for Participation in this Clinical Trial
Inclusion criteria:
- Newly diagnosed patients (< 3years) with type 2 diabetes.
- Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
- No previous treatment with oral or parenteral glucose-lowering therapy.
Exclusion criteria:
- History of lactic acidosis.
- Anemia (<11g for males, <10 g for females).
- Unstable or severe NY Heart Association-class 3 or 4.
- Any NY Heart Association congestive heart failure.
- Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trial, MD, PhD Study Director GlaxoSmith Kline
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00279045
Study ID Number: 49653/048
ClinicalTrials.gov Identifier: NCT00279045
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
