A Phase 4 interventional study of Sitagliptin 100mg and Placebo Oral Tablet in Genetics Disease, Type2 Diabetes and Heart Failure, sponsored by University of Pennsylvania. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by University of Pennsylvania · Phase 4, Interventional, and Other
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.
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.
403 studies on the registry are indexed under Genetic Diseases, Inborn; 145 are open to participants now.
This study's planned enrollment of 20 is below the median of 54 across 202 interventional studies indexed under Genetic Diseases, Inborn.
Browse Genetic Diseases, Inborn studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
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Exclusion Criteria:
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.
Drug: Sitagliptin 100mg · Drug: Placebo Oral Tablet
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.
Drug: Sitagliptin 100mg · Drug: Placebo Oral Tablet
Sitagliptin will be administered daily for 7 days, with a study day on day 7.
Also known as: Januvia
Placebo will be administered daily for 7 days, with a study day on day 7.
Dipeptidyl peptidase 4 (DPP4)
DPP4 activity and antigen concentration
Time frame: during study days 1 and 2
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.
Time frame: 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.
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
Measured via an automated blood pressure cuff approximately every 15 minutes
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)
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.
Time frame: 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.
Time frame: 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.
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
Measured via an automated blood pressure cuff approximately every 15 minutes
Time frame: Before the meal and for 4 hours after (t=-15 through t=240 min) on study days 1 and 2
Plan to share: Yes — Results will be deidentified for outcomes of interest from this pilot study.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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