CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 61 enrolled
Drug / intervention
Sitagliptin +1 moredrug
Likely dose
Not stated in 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/NCT01928199
NCT01928199Phase 4Completed

A Single Center, Randomized, Double-blind Controlled Trial of Sitagliptin Versus Placebo to Reduce the Incidence and Severity of New-onset Diabetes After Kidney Transplant

Washington University School of Medicine·interventional·Posted Aug 23, 2013·Updated Dec 30, 2022

In Brief

A Phase 4 clinical trial evaluating Sitagliptin and Placebo for Posttransplant Diabetes Mellitus. Completed, enrolled 61 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether sitagliptin is effective in preventing the development of new-onset diabetes after kidney transplant (NODAT). Up to one-third of previously non-diabetic patients develop NODAT after a kidney transplant. Corticosteroids and calcineurin inhibitors are two commonly utilized anti-rejection medications that contribute to diabetes development through multiple mechanisms; including decreased insulin production by the pancreas. Sitagliptin is an oral medication that results in increased insulin secretion. We hypothesize that administration of sitagliptin to transplant recipients identified to be at risk for diabetes development will reduce the incidence and severity of NODAT.

Study Details

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

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 23, 2013
Enrollment StartSep 1, 2013
Primary CompletionJun 1, 2020
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 12.9 years ago

Interventions

Sitagliptindrug

Placebodrug