At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 68 enrolled
Drug / intervention
sitagliptin phosphate +3 moredrug
Likely dose
sitagliptin phosphate 100 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 Multicenter, Randomized, Open-label Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With T2 DM With Inadequate Glycemic Control on Metformin
In Brief
A Phase 3 clinical trial evaluating sitagliptin phosphate, Comparator: metformin, and 1 other intervention for Diabetes Mellitus, Non-Insulin-Dependent. Completed, enrolled 68 participants.
Detailed Summary
After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Non-Insulin-Dependent
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2007
Primary CompletionJun 2008
First PostedApr 2009
TodayJul 2026
First PostedApr 3, 2009
Enrollment StartFeb 1, 2007
Primary CompletionJun 27, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.2 years ago
Interventions
sitagliptin phosphatedrug
sitagliptin 100 mg Once a day (QD) for 24 weeks
Comparator: metformindrug
metformin 850 mg Twice a day (BID) for 24 weeks
Comparator: metformindrug
metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks
Comparator: Antidiabetic Standard of Caredrug
Patient can take any oral antidiabetic drug (other than metformin)