Sitagliptin for Type 2 Diabetes with Genetic Mutation

Recruiting in Palo Alto (17 mi)

Overseen byJessica R Wilson, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Pennsylvania

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-70 with likely decreased DPP4 enzyme activity due to genetics, and who are part of the Penn Medicine Biobank. Participants should match controls in age, gender, race, BMI, hypertension and diabetes status, renal function, and certain medication use. Exclusions include severe kidney or liver disease, significant heart conditions like heart transplants, insulin or other specific diabetes drug use (except metformin), recent acute illness or hospitalization.

Inclusion Criteria

I match the study's required age, gender, race, BMI, and health conditions.

You are part of the Penn Medicine Biobank and are open to being contacted for future research studies.

I am between 18 and 70 years old and likely have low DPP4 levels.

Exclusion Criteria

I have a severe lung condition.

Inability to comprehend study procedures

I have Type 1 diabetes.

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Participant Groups

The trial tests if Sitagliptin (a DPP4 inhibitor) affects blood sugar levels after a meal differently in people with genetic variations that decrease DPP4 enzyme activity compared to a placebo. It also looks at whether it changes levels of substances broken down by DPP4 in these individuals versus matched controls without the genetic variation.

2Treatment groups

Experimental Treatment

Group I: Crossover BAExperimental Treatment2 Interventions

Subjects in arm B will first receive sitagliptin 100mg/d for 7 days in the first intervention followed by placebo for 7 days in the crossover intervention.

Group II: Crossover ABExperimental Treatment2 Interventions

Subjects in arm A will first receive placebo daily for 7 days in the first intervention followed by sitagliptin 100mg/d for 7 days in the crossover intervention.