Sitagliptin Response Study

(PRS Trial)

Overseen By Kamah Woelfel

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Maryland, Baltimore

Must not be taking: Drugs altering sitagliptin

Disqualifiers: Pregnancy, Diabetes, Anemia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes drugs that might alter the response to sitagliptin. It's best to discuss your current medications with the trial physician.

Is sitagliptin generally safe for humans?

Sitagliptin is generally well tolerated in humans, with common side effects including upper respiratory infections, headaches, and stomach upset. There have been reports of more serious issues like pancreatitis (inflammation of the pancreas) and joint pain, so ongoing monitoring is important. ^{1 2 3 4 5}

How does the drug sitagliptin differ from other treatments for diabetes?

Sitagliptin is unique because it works by inhibiting the enzyme DPP-4, which increases levels of incretin hormones like GLP-1, enhancing insulin secretion and improving blood sugar control without causing weight gain. Unlike some other diabetes medications, it also helps restore islet cell function and mass, potentially offering long-term benefits in managing diabetes. ^{6 7 8 9 10}

What data supports the effectiveness of the drug sitagliptin in improving glucose tolerance?

Research shows that sitagliptin, a drug used for type 2 diabetes, helps control blood sugar levels in patients who haven't responded well to other diabetes medications. This suggests it could be effective in improving glucose tolerance. ^{11 12 13 14 15}

Who Is on the Research Team?

Amber L Beitelshees, PharmD, MPH

Principal Investigator

University of Maryland, Baltimore

Simeon I Taylor, MD, PhD

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This study is seeking healthy, non-diabetic volunteers to understand how different people react to the diabetes medication sitagliptin. Participants will be involved in two clinic visits for testing over a span of 7 weeks.

Inclusion Criteria

I am older than 18.

Members of Old Order Amish community in Lancaster, PA

Exclusion Criteria

I am not on medications that would affect sitagliptin treatment.

I am not pregnant or will be tested for pregnancy before treatment.

Anemia: hematocrit < 35%

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive sitagliptin or placebo 2 hours prior to the oral glucose tolerance test

6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Oral Glucose Tolerance Test

Trial Overview The trial is examining how individuals process sugar after taking sitagliptin by using an Oral Glucose Tolerance Test (OGTT), where participants drink glucose and have their blood tested at intervals to measure sugar and insulin levels.

How Is the Trial Designed?

Group I: Sitagliptin Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Placebo given 2 hours prior to the oral glucose tolerance test

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Citations

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Retrospective analysis on the efficacy, safety and treatment failure group of sitagliptin for mean 10-month duration. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Comparative safety and effectiveness of sitagliptin in patients with type 2 diabetes: retrospective population based cohort study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effect of sitagliptin on blood glucose control in patients with type 2 diabetes mellitus who are treatment naive or poorly responsive to existing antidiabetic drugs: the JAMP study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

Short- and long-term effect of sitagliptin after near normalization of glycemic control with insulin in poorly controlled Japanese type 2 diabetic patients. [2021]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Optimal candidates for the switch from glimepiride to sitagliptin to reduce hypoglycemia in patients with type 2 diabetes mellitus. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and hypoglycemic risk of sitagliptin in obese/overweight patients with type 2 diabetes compared with GLP-1 receptor agonists: A meta-analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of sitagliptin in clinical studies: a pooled analysis of data from 10,246 patients with type 2 diabetes. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Unresponsive Intractable Chronic Headache With Sitagliptin. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse Drug Events Associated with sitagliptin Versus canagliflozin for the Treatment of Patients with Type 2 Diabetes Mellitus: A Systematic Comparison Through a Meta-Analysis. [2023]

11. Japan pubmed.ncbi.nlm.nih.gov

Preliminary study characterizing the use of sitagliptin for glycemic control in healthy Beagle dogs with normal gluco-homeostasis. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Inhibition of DPP-4 with sitagliptin improves glycemic control and restores islet cell mass and function in a rodent model of type 2 diabetes. [2022]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Sitagliptin Increases Beta-Cell Function and Decreases Insulin Resistance in Newly Diagnosed Vietnamese Patients with Type 2 Diabetes Mellitus. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Effect of single-dose DPP-4 inhibitor sitagliptin on β-cell function and incretin hormone secretion after meal ingestion in healthy volunteers and drug-naïve, well-controlled type 2 diabetes subjects. [2018]

15. United States pubmed.ncbi.nlm.nih.gov

Sitagliptin Improves the Impaired Acute Insulin Response during a Meal Tolerance Test in Japanese Patients with Type 2 Diabetes Mellitus: A Small-Scale Real-World Study. [2021]