Sitagliptin Response Study
(PRS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how healthy, non-diabetic people respond to sitagliptin, a medication used to treat diabetes. Participants will take either sitagliptin or a placebo and undergo tests to measure how their bodies process sugar. The study involves two clinic visits, each lasting about 5 hours, where an oral glucose tolerance test will be conducted. This trial seeks healthy members of the Old Order Amish community in Lancaster, PA, who do not have diabetes or significant health issues.
As a Phase 4 trial, this research helps determine how an already FDA-approved and effective treatment benefits more patients.
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.
What is the safety track record for sitagliptin?
Research has shown that sitagliptin is generally safe for people. In studies involving over 14,000 patients with type 2 diabetes, taking 100 mg of sitagliptin daily proved to be safe, with most participants experiencing no serious side effects. One study found that sitagliptin did not increase the risk of heart problems compared to a placebo. Since the FDA has already approved sitagliptin for treating diabetes, its safety for that use is well-established. In this trial, researchers will examine how healthy individuals without diabetes respond to the medication.12345
Why are researchers enthusiastic about this study treatment?
Sitagliptin is unique because it enhances the body's natural ability to regulate blood sugar by inhibiting the enzyme DPP-4, which increases levels of incretin hormones. Unlike many standard treatments for type 2 diabetes that directly stimulate insulin production or increase insulin sensitivity, Sitagliptin provides a different approach by helping the pancreas release the right amount of insulin when blood sugar levels are high. Researchers are excited about Sitagliptin because it offers a more targeted mechanism of action, potentially leading to fewer side effects and improved blood sugar control, especially when administered just hours before a glucose challenge.
What is the effectiveness track record for sitagliptin in treating diabetes?
Research has shown that sitagliptin, which participants in this trial may receive, effectively controls blood sugar levels. Studies have found that it significantly lowers sugar levels during the oral glucose tolerance test (OGTT), which checks how well the body handles sugar. Specifically, one study found that sitagliptin reduced the rise in blood sugar during this test, helping to prevent spikes. Additionally, sitagliptin has been shown to lower A1C levels, which measure average blood sugar over time, by up to 0.94%. This indicates that sitagliptin can help keep blood sugar levels stable, which is important for managing diabetes.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sitagliptin or placebo 2 hours prior to the oral glucose tolerance test
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Oral Glucose Tolerance Test
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor