At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,246 enrolled
Drug / intervention
sitagliptin phosphate (+) metformin hydrochloride +1 moredrug
Likely dose
sitagliptin phosphate (+) metformin hydrochloride 500 mgfrom 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, Active-Comparator Controlled, Clinical Trial to Study the Efficacy and Safety of MK0431A for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM)
In Brief
A Phase 3 clinical trial evaluating sitagliptin phosphate (+) metformin hydrochloride and metformin for Type 2 Diabetes Mellitus. Completed, enrolled 1,246 participants.
Detailed Summary
The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2007
Enrollment StartJun 2007
Primary CompletionNov 2008
Study CompletionApr 2009
TodayJul 2026
First PostedJun 5, 2007
Enrollment StartJun 19, 2007
Primary CompletionNov 3, 2008
Study CompletionApr 27, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.1 years ago
Interventions
sitagliptin phosphate (+) metformin hydrochloridedrug
sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.
metformindrug
metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period