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DPP4 Inhibitor

Sitagliptin for Type 2 Diabetes with Genetic Mutation

Phase 4

Recruiting

Led By Jessica R Wilson, MD, MS

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Severe pulmonary disease

Type 1 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before the meal (t=-15 or -1 min) on study days 1 and 2

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing whether a DPP4 inhibitor can help people with a specific gene mutation by reducing DPP4 activity and glucose levels.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Sitagliptin may cause side effects such as headaches, upper respiratory tract infections, sore throat and nasal congestion; stomach problems like diarrhea; joint pain; skin reactions; low blood sugar when combined with other diabetes medications.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe lung condition.

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I have Type 1 diabetes.

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I have stomach or intestine problems that could affect how a drug works.

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I have not been hospitalized or had a serious illness like an infection in the last two weeks.

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My blood's ability to carry oxygen is significantly reduced.

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My liver is not functioning well, with enzymes much higher than normal.

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I am on long-term blood thinners.

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I have had a heart transplant.

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My kidney function is reduced with an eGFR below 50.

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I do not have severe brain or mental health conditions.

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I use insulin.

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I am taking GLP-1 agonist or DPP4 inhibitor medication.

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I am taking diabetes medication other than metformin, or I am matched with controls.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before the meal or at baseline (t=-15 or -1 min) on study days 1 and 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before the meal or at baseline (t=-15 or -1 min) on study days 1 and 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and before the meal or at baseline (t=-15 or -1 min) on study days 1 and 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dipeptidyl peptidase 4 (DPP4)

Secondary study objectives

CD26

Disposition index

Glucagon-like peptide-1 (GLP-1)

+5 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sitagliptin 100mg

2019

Completed Phase 4

~3640

Placebo Oral Tablet

2020

Completed Phase 4

~2490