CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Sitagliptin +3 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/NCT01951339
NCT01951339N/ACompleted

Impact of Sitagliptin on Cardiovascular Exercise Performance in Type 2 Diabetes

University of Colorado, Denver·interventional·Posted Sep 26, 2013·Updated Jul 12, 2023

In Brief

A clinical study evaluating Sitagliptin, Glimepiride, and 1 other intervention for Type 2 Diabetes and Cardiovascular Disease. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The goal of this study is to examine whether sitagliptin, an agent which enhances the action of hormones that control the release of insulin and is already in clinical use for type 2 diabetes, might also improve functional exercise capacity. Specific aims: 1\. To test whether sitagliptin will improve functional exercise capacity in persons with type 2 diabetes compared to glimepiride. 1a. The primary outcome will be peak oxygen consumption (VO2peak) and oxygen uptake kinetics (VO2 kinetics). 1b. Secondary outcomes include cardiac function, endothelial function and tissue oxygen saturation (STO2) as well as health-related quality of life. 2\. To evaluate the impact of sitagliptin on muscle mitochondrial function 2a. The primary outcome to address this aim will be 31P measurements (phosphocreatine, free inorganic phosphate, adenosine triphosphate peaks, adenosine diphosphate and pH) Impact: Novel approaches are needed to decrease excess cardiovascular morbidity and mortality in diabetes. Diabetes impairs cardiovascular fitness and thereby mortality. A demonstration that sitagliptin improves cardiovascular fitness, (and possibly mitochondrial function) will provide important new data pertinent to the management of diabetes and pre-diabetes.

Study Details

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

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 26, 2013
Enrollment StartOct 1, 2013
Primary CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 12.8 years ago

Interventions

Sitagliptindrug

100 mg sitagliptin

Glimepiridedrug

Active Comparator 2mg glimepiride

Placebodrug

2 mg placebo once daily

Placebodrug

100 mg placebo once daily for three months