Sitagliptin for Type 2 Diabetes with Genetic Mutation

Overseen By Jessica R Wilson, MD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Pennsylvania

Must not be taking: Insulin, GLP-1 agonists

Disqualifiers: Pregnancy, Type 1 diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Jessica R Wilson, MD, MS

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Sitagliptin

Participants receive sitagliptin 100 mg/d for 7 days

7 days

1 visit (in-person) on day 7

Washout

A 4-week washout period between treatment phases

4 weeks

Treatment - Placebo

Participants receive placebo daily for 7 days

7 days

1 visit (in-person) on day 7

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Oral Tablet
• Sitagliptin 100mg

Trial Overview 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.

How Is the Trial Designed?

Group I: Crossover BA Experimental Treatment 2 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 AB Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+