CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 38 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.

Search/NCT01859793
NCT01859793Phase 4Completed

A Randomized, Crossover Design Study of Acute and Chronic Effects of Sitagliptin on Endothelial Function in Humans With Type 2 Diabetes on Background Metformin

Medical College of Wisconsin·interventional·Posted May 22, 2013·Updated Oct 21, 2016

In Brief

A Phase 4 clinical trial evaluating sitagliptin and Placebo for Diabetes and Atherosclerosis. Completed, enrolled 38 participants across 1 site.

Detailed Summary

The study is being performed to determine whether sitagliptin, a dipeptidyl peptidase-4 inhibitor, both acutely and chronically improves blood vessel function. Patients with type 2 diabetes who are on metformin will be enrolled in this study for up to 22 weeks in this double blinded cross over study where they will receive a sitagliptin pill once a day for 8 weeks and during a separate 8 weeks receive a matching placebo pill. The treatment periods are divided by a 4 week period. Blood vessel function will be measured by ultrasound before and after a single dose of sitagliptin and placebo, as well as after 8 weeks of treatment with each. Blood will also be taken to measure blood markers of inflammation at each time the ultrasounds are performed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 22, 2013
Enrollment StartJun 1, 2013
Primary CompletionJan 1, 2016
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 13.1 years ago

Interventions

sitagliptindrug

100 mg pill, administered once/day orally

Placebodrug

Matching placebo in appearance given once/day orally