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Sitagliptin

Clinical trials are studying Sitagliptin in people with type 2 diabetes. These studies look at how well it works in different treatment plans, including personalized care and comparison with other diabetes medicines. The main goals include better blood sugar control and other diabetes-related outcomes.

Table of contents

Trial overview

These clinical trials are studying Sitagliptin in people with type 2 diabetes mellitus or type 2 diabetes.[1][2][3] All three studies are Phase 3 interventional trials, which means researchers are testing treatment plans in larger patient groups and comparing outcomes between groups.[1][2][3]

Who is being studied

The main target population is adults with type 2 diabetes, especially people whose diabetes is not well controlled.[1] One trial also includes people with cardiovascular autonomic neuropathy, which is nerve damage that can affect heart control.[2] Another trial focuses on adult participants with type 2 diabetes in a comparison of tirzepatide with intensified conventional care, where Sitagliptin is one of the treatment options listed in the study arms.[3]

In the first study, the researchers want to see whether pharmacogenetic-guided treatment can improve control of type 2 diabetes compared with optimized standard treatment.[1] Pharmacogenetic-guided treatment means the choice of treatment is based on a person’s genes.[1]

What is being measured

The main result in the genetic-treatment study is the proportion of patients who reach a goal HbA1c of 7% or less at Week 24.[1] HbA1c is a blood test that shows average blood sugar over time.[1]

In the autonomic neuropathy study, the main outcomes include change in heart rate variability and a measure called the LF:HF ratio, with the goal of seeing a 20% improvement from baseline to the end of treatment at 6 months.[2] The study also looks at progression of cardiovascular autonomic neuropathy using CART parameters and glucose variability from baseline to the end of treatment.[2]

In the SURPASS-EARLY study, the main outcome is change from baseline in HbA1c over 104 weeks.[3] The brief summary says the study aims to show that tirzepatide is non-inferior to intensified conventional care, meaning it works at least as well as the comparison treatment for this measure.[3]

Trial designs and treatment comparisons

These studies are interventional, so the research team assigns treatment plans rather than only observing usual care.[1][2][3] The first trial compares pharmacogenetic-guided treatment with optimized standard treatment and includes Sitagliptin among several diabetes medicines listed in the intervention set.[1]

The second trial compares SGLT-2 inhibitor-based approaches and includes Sitagliptin and other diabetes medicines such as linagliptin, semaglutide, pioglitazone, insulin, canagliflozin, dapagliflozin, and others in the intervention list.[2] Its objectives are to study possible effects on heart-related nerve function and progression of autonomic neuropathy in people with type 2 diabetes.[2]

The SURPASS-EARLY study compares tirzepatide with intensified conventional care and lists Sitagliptin among several treatment options used in the study arms.[3] The trial is designed to compare blood sugar change over time in adults with type 2 diabetes.[3]

Trial phases and study size

All three studies are in Phase 3, which is an advanced stage of clinical research.[1][2][3] Phase 3 studies usually involve more people than early studies and are used to learn how well a treatment works in patient groups.[1][2][3]

The planned enrollment is 504 participants in the genetics-based diabetes study, 80 participants in the autonomic neuropathy study, and 781 participants in the SURPASS-EARLY study.[1][2][3] This shows that the Sitagliptin-related research includes both smaller focused studies and larger comparative studies.[1][2][3]

What these trials mean for patients

For patients, these studies are mainly asking whether different ways of choosing or comparing diabetes treatment can improve blood sugar control and related health outcomes.[1][2][3] The trials focus on people with type 2 diabetes, and one also looks at a nerve-related heart problem that can happen in diabetes.[2]

Because the studies measure outcomes like HbA1c, heart rate variability, and progression of autonomic neuropathy, they are trying to learn not only whether treatment lowers blood sugar, but also whether it may affect diabetes-related complications.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
2025-520686-46-00 Phase 3 Type 2 diabetes mellitus Authorised 504
2025-521748-39-00 Phase 3 Type 2 diabetes Authorised 80
NCT05433584 Phase 3 Type 2 diabetes Authorised 781

FAQ

  • What are the Sitagliptin trials trying to find out? The trials are checking whether Sitagliptin helps improve diabetes control. They measure outcomes such as HbA1c, which is a blood test showing average blood sugar over time.
  • Who can take part in these studies? The studies focus on adults with type 2 diabetes, including people whose diabetes is not well controlled. One trial also looks at people with type 2 diabetes and cardiovascular autonomic neuropathy.
  • What phase are the Sitagliptin trials in? The trials listed here are Phase 3 studies. Phase 3 means the treatment is being tested in larger groups to see how well it works in real patient groups.
  • What conditions are being studied with Sitagliptin? The main condition is type 2 diabetes mellitus. One study also looks at cardiovascular autonomic neuropathy, a type of nerve problem that can affect heart control.
  • How is Sitagliptin being studied in these trials? It is being studied as part of different treatment strategies, including personalized treatment based on genetics and comparison with other diabetes medicines. The trials compare outcomes between treatment groups.

Ongoing Clinical Trials on Sitagliptin

  • Study on the Effects of Ertugliflozin and Semaglutide on Heart Health in Patients with Type 2 Diabetes

    Recruiting

    1 1 1 1
    Investigated drugs:
    Italy

  • Evaluation of Long-Term Efficacy and Safety of Tirzepatide Versus Intensified Conventional Care in Early Treatment of Type 2 Diabetes in Adults

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    Czechia Germany Italy Romania Slovakia

  • Study on Personalized Treatment Using Dapagliflozin, Dulaglutide, and Metformin for Patients with Uncontrolled Type 2 Diabetes

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Spain

Glossary

  • Type 2 diabetes mellitus: A long-term condition where the body does not use blood sugar normally, so sugar levels can stay too high.
  • HbA1c: A blood test that shows the average blood sugar level over the past 2 to 3 months.
  • Phase 3: A later stage of clinical research with larger groups of people, used to test how well a treatment works.
  • Interventional study: A study where researchers assign a treatment or care plan and then measure the results.
  • Enrollment: The number of people planned or included in a study.
  • Primary outcome: The main result the researchers want to measure in a trial.
  • Pharmacogenetic-guided treatment: Treatment chosen using information from a person's genes to help match therapy to the patient.
  • Optimized standard treatment: Usual care that has been adjusted as well as possible using standard medical practice.
  • Cardiovascular autonomic neuropathy: Nerve damage that can affect how the heart and blood vessels are controlled.
  • Heart rate variability: A measure of the small changes in time between heartbeats.

References