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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

Controls are defined as adults who are matched to cases by: age, gender, race, BMI, hypertension status, diabetes status, renal function, and medication use that may affect outcomes of interest

Cases are defined as adults 18-70 years with likely decreased DPP4

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dipeptidyl peptidase 4 (DPP4)

Secondary outcome measures

CD26

Disposition index

Glucagon-like peptide-1 (GLP-1)

+5 more

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

Placebo Oral Tablet

2017

Completed Phase 4

~2250

Sitagliptin 100mg

2019

Completed Phase 4

~3640

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,068 Total Patients Enrolled

Jessica R Wilson, MD, MSPrincipal InvestigatorUniversity of Pennsylvania

1 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

Sitagliptin 100mg (DPP4 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04323189 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it plausible to join this trial?

"This research project is seeking 20 participants with a genetic disorder, aged between 18 and 80. To be eligible, individuals must meet the following criteria: Cases are classed as adults from 18-70 years old that likely possess weakened DPP4., Controls should match cases in terms of age, gender, ethnicity, BMI measurements, hypertension status, diabetes symptoms , renal function levels and any drugs used which may alter outcomes of interest., Lastly all applicants need to have consented for their records to be saved on Penn Medicine Biobank so they can potentially partake in future studies."

Answered by AI

What is the participant quota for this medical investigation?

"Yes, according to clinicaltrials.gov, this medical trial is actively recruiting patients with the original posting date being August 26th 2020 and most recent update on December 30th 2021. The study will incorporate a total of 20 participants from one site."

Answered by AI

Is the study open to individuals aged sixty and above?

"This clinical trial has a minimum age requirement of 18 years old, while the upper limit is set at 80."

Answered by AI

Are individuals eligible to participate in the current iteration of this research?

"Clinicaltrials.gov displays that this trial is currently enrolling patients, with its initial posting occurring on August 26th 2020 and the most recent update occurring on December 30th 2021."

Answered by AI