At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 206 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.
A Multicenter, Double-Blind, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Sitagliptin in Elderly Patients With Type 2 Diabetes Mellitus
In Brief
A Phase 3 clinical trial evaluating sitagliptin phosphate and Comparator: Placebo for Type 2 Diabetes. Completed, enrolled 206 participants.
Detailed Summary
To evaluate the effect of treatment with sitagliptin compared to placebo in elderly patients with type 2 diabetes mellitus who have poor glycemic control with diet and exercise.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2006
First PostedMar 2006
Primary CompletionMar 2008
TodayJul 2026
First PostedMar 22, 2006
Enrollment StartMar 8, 2006
Primary CompletionMar 12, 2008
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 20.3 years ago
Interventions
sitagliptin phosphatedrug
Once daily (q.d.) administration of sitagliptin 100 mg tablet (or 50 mg based on creatinine clearance). For up to a 24-wk treatment period.
Comparator: Placebodrug
sitagliptin matching placebo for up to a 24-wk treatment period.