Sitagliptin's Effects on Glucose-stimulated Insulin Secretion and Oral Glucose
Study on Sitagliptin's Effects on Glucose and Insulin
Plain English Summary
Pharmacogenetics of Response to Sitagliptin (PRS) is a Phase 4 clinical trial sponsored by University of Maryland, Baltimore studying Diabetes. Tests how different people respond to sitagliptin, a diabetes medication. For healthy, non-diabetic volunteers aged 18 and older. Participation involves 2 clinic visits 4-6 weeks apart, including an oral glucose tolerance test. Alternatives include other diabetes management strategies like diet, exercise, and other medications. The trial aims to enroll 400 participants.
Official Summary
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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Healthy adults aged 18 and older can join. Pregnant women and those with diabetes cannot join. Age: 18 years and older. Health requirements: No diabetes, no significant health issues, and normal liver and kidney function. This trial is studying Diabetes, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure how sitagliptin enhances insulin secretion and improves glucose tolerance, helping patients better manage their diabetes. The specific primary outcome measures are: Sitagliptin-induced enhancement of early insulin secretion (6 weeks); Sitagliptin-induced change in glucose tolerance (6 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.
Why This Trial Matters
This trial aims to understand how sitagliptin affects glucose and insulin in different individuals, filling a gap in personalized diabetes treatment. This research targets Diabetes, where improved treatment options are needed.
Investor Insight
Market size is large, with a competitive landscape focused on personalized diabetes treatments, and a high approval probability given the sponsor's expertise. This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.
Is This Trial Right for Me?
Ask your doctor if you have any health issues that might affect your participation. You will have 2 clinic visits, each lasting about 5 hours, for blood tests and an oral glucose tolerance test. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: CROSSOVER
- Masking: SINGLE
- Enrollment: 400 participants
Interventions
- PROCEDURE: Oral Glucose Tolerance Test — Three hour glucose tolerance test
Primary Outcomes
- Sitagliptin-induced enhancement of early insulin secretion (6 weeks)
- Sitagliptin-induced change in glucose tolerance (6 weeks)
Secondary Outcomes
- Area under the curve for insulin concentration (6 weeks)
- Area under the curve for glucose concentration (6 weeks)
- Area under the curve for intact GIP (6 weeks)
- Area under the curve for intact GLP1 (6 weeks)
- Area under the curve for C-peptide levels (6 weeks)
Full Eligibility Criteria
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 Locations
- University of Maryland Amish Research Clinic, Lancaster, Pennsylvania, United States
Frequently Asked Questions
What is clinical trial NCT06813014?
NCT06813014 is a Phase 4 INTERVENTIONAL study titled "Pharmacogenetics of Response to Sitagliptin (PRS)." It is currently not yet recruiting and is sponsored by University of Maryland, Baltimore. The trial targets enrollment of 400 participants.
What conditions does NCT06813014 study?
This trial investigates treatments for Diabetes. The primary condition under study is Diabetes.
What treatments are being tested in NCT06813014?
The interventions being studied include: Oral Glucose Tolerance Test (PROCEDURE). Three hour glucose tolerance test
What does Phase 4 mean for NCT06813014?
Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.
What is the current status of NCT06813014?
This trial is currently "Not Yet Recruiting." It started on 2026-12. The estimated completion date is 2032-12.
Who is sponsoring NCT06813014?
NCT06813014 is sponsored by University of Maryland, Baltimore. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06813014?
The trial aims to enroll 400 participants. The trial has not yet started recruiting.
How is NCT06813014 designed?
This is a interventional study, uses randomized allocation, follows a crossover design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06813014?
The primary outcome measures are: Sitagliptin-induced enhancement of early insulin secretion (6 weeks); Sitagliptin-induced change in glucose tolerance (6 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06813014 being conducted?
This trial is being conducted at 1 site, including Lancaster, Pennsylvania (United States).
Where can I find official information about NCT06813014?
The official record for NCT06813014 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06813014. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06813014 testing in simple terms?
Tests how different people respond to sitagliptin, a diabetes medication. For healthy, non-diabetic volunteers aged 18 and older.
Why is this trial significant?
This trial aims to understand how sitagliptin affects glucose and insulin in different individuals, filling a gap in personalized diabetes treatment.
What are the potential risks of participating in NCT06813014?
Key risks include temporary discomfort during the oral glucose tolerance test and potential side effects like nausea or headache. Side effects are generally mild and managed by the study team. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06813014?
Ask your doctor if you have any health issues that might affect your participation. You will have 2 clinic visits, each lasting about 5 hours, for blood tests and an oral glucose tolerance test. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06813014 signal from an investment perspective?
Market size is large, with a competitive landscape focused on personalized diabetes treatments, and a high approval probability given the sponsor's expertise. This is a Phase 4 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves 2 clinic visits 4-6 weeks apart, including an oral glucose tolerance test. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.