CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 36 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/NCT00660075
NCT00660075Phase 3Completed

A Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Evaluate The Effects of Sitagliptin on Postprandial Plasma Lipoprotein Concentrations in Men With Type 2 Diabetes

Laval University·interventional·Posted Apr 17, 2008·Updated Dec 11, 2012

In Brief

A Phase 3 clinical trial evaluating Sitagliptin and Placebo for Diabetes Mellitus and Postprandial Lipemia. Completed, enrolled 36 participants across 1 site.

Detailed Summary

Sitagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-4), and has been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes mainly through incretin hormone-mediated improvements in islet function. Although clinical studies to date indicate that fasting lipid levels are minimally affected by DPP-4 inhibitor treatment, animal studies suggested that DPP-4 inhibition reduce intestinal triglyceride (TG) absorption and apolipoprotein production and increased chylomicron catabolism. Therefore, the present study was designed to examine the effects of sitagliptin on postprandial lipemia in patients with type 2 diabetes. A possible reduction in postprandial atherogenic triglyceride-rich lipoproteins (TRL) levels by sitagliptin would add to therapeutic utility of this DPP-4 inhibitor and suggest the potential to reduce cardiovascular risk in patients with type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 17, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJan 1, 2009
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.2 years ago

Interventions

Sitagliptindrug

Sitagliptin 100 mg/d for 6 weeks

Placebodrug

Placebo for 6 weeks