At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 4,426 enrolled
Drug / intervention
Rosiglitazone +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Rosiglitazone, glyburide, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 4,426 participants across 490 sites in 17 countries.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesAustria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2000
First PostedJan 2006
Primary CompletionJun 2006
Study CompletionJun 2006
TodayJul 2026
First PostedJan 19, 2006
Enrollment StartJan 3, 2000
Primary CompletionJun 1, 2006
Study CompletionJun 19, 2006
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 20.5 years ago
Interventions
Rosiglitazonedrug
glyburidedrug
metformindrug