Pharmacogenetics of Response to Sitagliptin (PRS)

University of Maryland Baltimore (UMB)

Status and phase: Not yet enrolling; Phase 4

Conditions: Diabetes

Treatments: Procedure: Oral Glucose Tolerance Test

Study type: Interventional

Funder types: Other

Identifiers

NCT06813014

HP-00111892

Details and patient eligibility

About

This is a research study to find out how different people respond to a medication called sitagliptin. Sitagliptin is an FDA approved medication that is used to treat diabetes. We are asking for healthy, non-diabetic volunteers to participate in this 7-week study. If you agree to participate, you will take part in 2 clinic visits that are 4-6 weeks apart. At the clinic visits you will have an oral glucose tolerance test (OGTT) and other blood tests to see how your body processes glucose (sugar). An OGTT is a test in which your drink glucose and then blood samples are taken afterward at specific time points to measure glucose and insulin in your blood. Each clinic visit will last about 5 hours.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• • Age: >18 years old

  • Members of Old Order Amish community in Lancaster, PA

Exclusion criteria

• • Pregnancy (reproductive age women will undergo pregnancy tests immediately before receiving the drug)

  • Diabetes: HbA1c > 6.5% or fasting plasma glucose >126 mg/dL
  • Estimated glomerular filtration rates (eGFR) <60 mL/min/1.73 m2
  • Anemia: hematocrit < 35%
  • Thyroid status: TSH<0.4 or TSH>5.5
  • ALT or AST in excess of 2X upper limit of normal
  • Drugs that in the physician's judgment would alter response to sitagliptin
  • Significant health issues that in the physician's judgment could increase the risk for participants.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

400 participants in 2 patient groups, including a placebo group

Sitagliptin

Experimental group

Description:

Sitagliptin 100 mg given 2 hours prior to the oral glucose tolerance test

Treatment:

Procedure: Oral Glucose Tolerance Test

Placebo

Placebo Comparator group

Description:

Placebo given 2 hours prior to the oral glucose tolerance test

Treatment:

Procedure: Oral Glucose Tolerance Test