At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
sitagliptin +1 moredrug
Likely dose
sitagliptin 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 Randomized Clinical Trial to Evaluate Glucose-Dependent Insulinotropic Effects of a Single Dose of a DPP-4 Inhibitor in Lean Healthy Males
In Brief
A Phase 1 clinical trial evaluating sitagliptin and Comparator: Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 12 participants.
Detailed Summary
This study will evaluate the effect of a single dose of sitagliptin on glucose dependent insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG) procedure.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2009
Enrollment StartMay 2009
Primary CompletionJun 2009
Study CompletionJul 2009
TodayJul 2026
First PostedApr 27, 2009
Enrollment StartMay 12, 2009
Primary CompletionJun 10, 2009
Study CompletionJul 21, 2009
TodayJul 2, 2026
Enrollment to primary: 28 daysPosted 17.2 years ago
Interventions
sitagliptindrug
Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test.
Comparator: Placebodrug
Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.