At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 441 enrolled
Drug / intervention
Comparator: Sitagliptin +2 moredrug
Likely dose
Sitagliptin 10 mg orally once dailyAI-extracted
Key inclusion· 1
- ✓Type 2 Diabetes Mellitus with inadequate glycemic control
Key exclusion· 1
- ✕Type 1 Diabetes Mellitus
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Glimepiride Alone or in Combination With Metformin
In Brief
A Phase 3 clinical trial evaluating Comparator: Sitagliptin, Comparator: Placebo, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 441 participants.
Detailed Summary
The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with Type 2 diabetes mellitus.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2005
First PostedMar 2005
Primary CompletionJun 2006
Study CompletionJan 2007
TodayJul 2026
First PostedMar 30, 2005
Enrollment StartMar 1, 2005
Primary CompletionJun 1, 2006
Study CompletionJan 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 21.3 years ago
Interventions
Comparator: Sitagliptindrug
sitagliptin 10 mg tablet, once daily for 54 weeks
Comparator: Placebodrug
Placebo oral tablet once daily for 24 weeks
Comparator: Pioglitazonedrug
Pioglitazone 30 mg tablet once daily for 30 weeks