Genetics DiseasePhase 4NCT04323189
Effects of Sitagliptin in Individuals With Genetically Decreased DPP4
A Phase 4 study testing Sitagliptin 100mg in people with Genetics Disease and Type2 Diabetes, run by University of Pennsylvania at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Genetics Disease, Type2 Diabetes, Heart Failure
- What is being tested?
- Sitagliptin 100mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2020to 28 Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant of the Penn Medicine Biobank who is willing to be recontacted to participate in future research.
- Cases are defined as adults 18-70 years with likely decreased DPP4.
- 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.
Who cannot join
- The study will exclude volunteers with any significant medical conditions that may interfere with study participation, data interpretation, or pose safety risk(s) to the subject.
- Recent hospitalization or acute illness such as infection within the past two weeks
- Pregnancy
- Use of insulin
- Use of a GLP-1 agonist or DPP4 inhibitor medication
- Use of oral diabetes agents other than metformin unless matched with controls
Show all 17Show fewer
- Type 1 diabetes
- Chronic steroid use or use within the last 30 days
- Significant liver disease including liver enzymes >3 x upper limit of normal range
- Renal dysfunction defined as eGFR< 50mL/min/1.73m2
- Significant cardiac disease such as heart transplantation
- Significant gastrointestinal conditions that may interfere with drug absorption or GLP-1 release including bariatric surgery
- Significant hematologic disease such as hematocrit <35%
- Use of chronic anticoagulation
- Severe pulmonary disease
- Severe neurologic or psychiatric disease
- Inability to comprehend study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the detailed description
Participants of this pilot clinical trial will be randomized in a blinded 2:2 crossover manner to receive placebo and sitagliptin 100 mg/d (DPP4 inhibitor), in random order. Subjects will receive each intervention for seven days, with a study day on day 7. Each intervention will be separated by a 4-week washout period. Each subject will have up to four separate visits: 1) DXA, echocardiogram, 2) cardiac MRI, 3) mixed meal during placebo, 4) mixed meal during sitagliptin.
The study will include 10 cases (heterozygous for DPP4 loss of function variant) and 10 controls.
- Conditions
- Genetics Disease, Type2 Diabetes, Heart Failure
- Being tested
- Sitagliptin 100mg, Placebo Oral Tablet
- Keywords
- genetics, sitagliptin, DPP4 inhibition, heart failure, type 2 diabetes
- Medical subject headings
- Genetic Diseases, Inborn, Heart Failure, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitagliptin 100mgDrug
Also called Januvia
Sitagliptin will be administered daily for 7 days, with a study day on day 7.
Placebo Oral TabletDrug
Placebo will be administered daily for 7 days, with a study day on day 7.
| Study group | Role | What they receive |
|---|---|---|
| Crossover AB | Other | 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. Receives: Drug: Sitagliptin 100mg; Drug: Placebo Oral Tablet |
| Crossover BA | Other | 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. Receives: Drug: Sitagliptin 100mg; Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dipeptidyl peptidase 4 (DPP4)
DPP4 activity and antigen concentration
Measured: during study days 1 and 2
Secondary outcomes (7)
Glucose Area Under the Curve
Glucose will be measured before after the mixed meal during sitagliptin and placebo. Area under the curve will be calculated based on at least 10 time points after the meal.
Measured: Before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2
Disposition index
Disposition index will be calculated from insulin sensitivity and insulin secretion. These variables will be computed using mathematical modeling of insulin and c-peptide. We will collect insulin and c-peptide at least 10 time points after the meal.
Measured: Calculated from samples collected before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2
Mean blood pressure
Measured via an automated blood pressure cuff approximately every 15 minutes
Measured: Before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2
Glucagon-like peptide-1 (GLP-1)
This is released in response to a meal and rapidly degraded by DPP4. We will collect samples for at least six time points after the meal.
Measured: Before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2
CD26
CD26 is DPP4 on T cells and monocytes.
Measured: Before the meal or at baseline (t=-15 or -1 min) on study days 1 and 2
Surrogate markers of lipolysis
Triglycerides, free fatty acids; We will collect samples at least six time points after the meal.
Measured: Before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2
Mean heart rate
Measured via an automated blood pressure cuff approximately every 15 minutes
Measured: Before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start26 Aug 2020
- Primary completion27 Feb 2025
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetics DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- blinded 2:2 crossover, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica R.Wilson, MD, MS, University of Pennsylvania
- Investigators
- Jessica R Wilson, MD, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323189
- Sponsor's protocol ID
- 834482
- Status last verified
- Jan 2026
- First submitted
- 25 Mar 2019
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be deidentified for outcomes of interest from this pilot study.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sitagliptin in Individuals With Genetically Decreased DPP4
- ClinicalTrials.gov ID
- NCT04323189
- Acronym / sponsor ID
- 834482
- Conditions
- Genetics Disease, Type2 Diabetes, Heart Failure
- Keywords
- genetics, sitagliptin, DPP4 inhibition, heart failure, type 2 diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants of this pilot clinical trial will be randomized in a blinded 2:2 crossover manner to receive placebo and sitagliptin 100 mg/d (DPP4 inhibitor), in random order. Subjects will receive each intervention for seven days, with a study day on day 7. Each intervention will be separated by a 4-week washout period. Each subject will have up to four separate visits: 1) DXA, echocardiogram, 2) cardiac MRI, 3) mixed meal during placebo, 4) mixed meal during sitagliptin.
The study will include 10 cases (heterozygous for DPP4 loss of function variant) and 10 controls.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- blinded 2:2 crossover, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Crossover AB | Other | Drug: Sitagliptin 100mg, Drug: Placebo Oral TabletSubjects 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. |
| Crossover BA | Other | Drug: Sitagliptin 100mg, Drug: Placebo Oral TabletSubjects 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant of the Penn Medicine Biobank who is willing to be recontacted to participate in future research.
- Cases are defined as adults 18-70 years with likely decreased DPP4.
- 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.
Key exclusion criteria (17 listed)
- The study will exclude volunteers with any significant medical conditions that may interfere with study participation, data interpretation, or pose safety risk(s) to the subject.
- Recent hospitalization or acute illness such as infection within the past two weeks
- Pregnancy
- Use of insulin
- Use of a GLP-1 agonist or DPP4 inhibitor medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sitagliptin 100mgAlso: JanuviaSitagliptin will be administered daily for 7 days, with a study day on day 7. | Drug | Crossover AB, Crossover BA |
| Placebo Oral TabletPlacebo will be administered daily for 7 days, with a study day on day 7. | Drug | Crossover AB, Crossover BA |
Primary outcome
Dipeptidyl peptidase 4 (DPP4)
Time frame: during study days 1 and 2
DPP4 activity and antigen concentration
7 secondary outcomes
Glucose Area Under the Curve
Time frame: Before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2
Disposition index
Time frame: Calculated from samples collected before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2
Mean blood pressure
Time frame: Before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2
Glucagon-like peptide-1 (GLP-1)
Time frame: Before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2
CD26
Time frame: Before the meal or at baseline (t=-15 or -1 min) on study days 1 and 2
Surrogate markers of lipolysis
Time frame: Before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2
Mean heart rate
Time frame: Before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Yes. Results will be deidentified for outcomes of interest from this pilot study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica R Wilson, MD, MS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sitagliptin 100mg in people with Genetics Disease and Type2 Diabetes, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dipeptidyl peptidase 4 (DPP4) (time frame: during study days 1 and 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.