At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 42 enrolled
Drug / intervention
Sitagliptin 100 mg/simvastatin 40 mg FDC +1 moredrug
Likely dose
Sitagliptin 100 mg/simvastatin 40 mg FDCfrom 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.
An Open-label Study to Assess the Safety and Tolerability of MK-0431D for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy
In Brief
A Phase 3 clinical trial evaluating Sitagliptin 100 mg/simvastatin 40 mg FDC and Metformin for Type 2 Diabetes Mellitus. Completed, enrolled 42 participants.
Detailed Summary
The purpose of this study is to examine the safety and tolerability of sitagliptin 100 mg/simvastatin 40 mg FDC (MK-0431D) in Vietnamese participants with type 2 diabetes mellitus with inadequate glycemic control on metformin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2012
Enrollment StartDec 2012
Primary CompletionMay 2013
TodayJul 2026
First PostedOct 8, 2012
Enrollment StartDec 7, 2012
Primary CompletionMay 29, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 13.7 years ago
Interventions
Sitagliptin 100 mg/simvastatin 40 mg FDCdrug
Sitagliptin 100 mg/simvastatin 40 mg FDC tablet administered once daily in the evening for 6 weeks
Metformindrug
Participants will continue pre-study dose of metformin tablet(s) \>=1000 per day