At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 30 enrolled
Drug / intervention
Sitagliptin phosphate +1 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.
An Open-label Study to Assess the Safety and Tolerability of JANUVIA (Sitagliptin) in 30 Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
In Brief
A Phase 3 clinical trial evaluating Sitagliptin phosphate and Metformin for Type 2 Diabetes. Completed, enrolled 30 participants.
Detailed Summary
This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin monotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2009
Enrollment StartMar 2010
Primary CompletionOct 2010
TodayJul 2026
First PostedDec 17, 2009
Enrollment StartMar 1, 2010
Primary CompletionOct 4, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.5 years ago
Interventions
Sitagliptin phosphatedrug
Sitagliptin 100 mg tablet by mouth once daily for 4 weeks.
Metformindrug
Stable dose of metformin tablet(s) by mouth (at least 1000 mg/day) for 4 weeks.