NCT04323189

Effects of Sitagliptin in Individuals With Genetically Decreased DPP4

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot clinical trial to test the hypothesis that during sitagliptin (DPP4 inhibitor), individuals heterozygous for DPP4 loss of function variants will have a reduction in DPP4 activity and antigen, lower glucose after a mixed meal, and higher levels of intact DPP4 substrates compared to during placebo and compared to matched controls.

Detailed description

Participants of this pilot clinical trial will be randomized in a blinded 2:2 crossover manner to receive placebo and sitagliptin 100 mg/d (DPP4 inhibitor), in random order. Subjects will receive each intervention for seven days, with a study day on day 7. Each intervention will be separated by a 4-week washout period. Each subject will have up to four separate visits: 1) DXA, echocardiogram, 2) cardiac MRI, 3) mixed meal during placebo, 4) mixed meal during sitagliptin. The study will include 10 cases (heterozygous for DPP4 loss of function variant) and 10 controls.

Conditions

• Genetics Disease
• Type2 Diabetes
• Heart Failure

Interventions

Type	Name	Description
DRUG	Sitagliptin 100mg	Sitagliptin will be administered daily for 7 days, with a study day on day 7.
DRUG	Placebo Oral Tablet	Placebo will be administered daily for 7 days, with a study day on day 7.

Timeline

• Start date: 2020-08-26
• Primary completion: 2025-02-27
• Completion: 2026-02-28
• First posted: 2020-03-26
• Last updated: 2026-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study