At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,172 enrolled
Drug / intervention
sitagliptin (MK0431) +1 moredrug
Likely dose
Sitagliptin 100 mg oral tablets once daily; glipizide 5–20 mg daily (titrated)AI-extracted
Key inclusion· 2
- ✓Age 18–78 years
- ✓Type 2 diabetes mellitus diagnosis
Key exclusion· 0
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK0431 Compared With Sulfonylurea Therapy in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
In Brief
A Phase 3 clinical trial evaluating sitagliptin (MK0431) and Comparator: glipizide for Diabetes Mellitus, Type 2. Completed, enrolled 1,172 participants.
Detailed Summary
The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2004
First PostedOct 2004
Primary CompletionMay 2006
Study CompletionMay 2007
TodayJul 2026
First PostedOct 25, 2004
Enrollment StartSep 1, 2004
Primary CompletionMay 1, 2006
Study CompletionMay 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 21.7 years ago
Interventions
sitagliptin (MK0431)drug
Sitagliptin 100 mg oral tablets of sitagliptin once daily.
Comparator: glipizidedrug
Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.