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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
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:Select...
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
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 moreTrial 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
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,063 Previous Clinical Trials
42,711,892 Total Patients Enrolled
Jessica R Wilson, MD, MSPrincipal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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