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Saxagliptin

Clinical trials investigating Saxagliptin are studying it in people with heart failure with reduced ejection fraction and adults with type 2 diabetes. These trials look at safety, treatment effects, and changes in key health measures such as heart failure events and HbA1c, a blood sugar marker.

Table of Contents

Trial overview

The source data include two clinical trials that mention Saxagliptin as part of the study treatment options.[1][2] One trial studied people with heart failure with reduced ejection fraction, and the other studied adults with type 2 diabetes.[1][2] These are interventional studies, which means the researchers assigned treatments and then measured results.[1][2]

Heart failure study

NCT05989503 was a completed randomized open-label trial in patients with heart failure with reduced ejection fraction.[1] It enrolled 172 people and was designed to compare two ways of starting treatment: giving angiotensin receptor-neprilysin inhibitor and SGLT2 inhibitor together, or starting SGLT2 inhibitor first and adding the other treatment later.[1] Saxagliptin appeared in one of the listed drug combinations in the study data.[1]

The study asked whether the safety of starting the two heart failure treatments at the same time was not worse than the step-by-step approach.[1] “Not worse than” is called non-inferior, which means the new approach is expected to perform at least as well as the comparison approach within a set margin.[1]

Type 2 diabetes study

NCT05433584 is an authorised Phase 3 study in adult participants with type 2 diabetes.[2] It enrolled 781 participants and compared tirzepatide with intensified conventional care.[2] Saxagliptin was one of the diabetes medicines listed in the intervention set for this trial.[2]

The main goal was to show that tirzepatide was not worse than intensified conventional care for change in HbA1c from baseline to Week 104.[2] HbA1c is a blood test that reflects average blood sugar over time, so it is a key measure in diabetes studies.[2]

Outcomes measured in the trials

The heart failure trial used a composite outcome, which combines several events into one main result.[1] These events included symptomatic hypotension, hyperkalaemia, hypokalemia, a major drop in eGFR, kidney failure outcomes, increased diuretic dose, intravenous diuretics, heart failure hospitalization, and death from cardiovascular causes during 6 months of follow-up.[1]

The diabetes trial focused on change in hemoglobin A1c (HbA1c) from the start of the study to Week 104.[2] This outcome helps show whether a treatment strategy improves long-term blood sugar control.[2]

Who was studied

The heart failure study involved patients with heart failure with reduced ejection fraction, and the study summary also mentioned HFmrEF, which means heart failure with mildly reduced ejection fraction.[1] The diabetes study involved adult participants with type 2 diabetes.[2] In both trials, Saxagliptin was part of the study drug list rather than the only treatment being tested.[1][2]

What these trials show about Saxagliptin research

Based on the source data, Saxagliptin is being studied in different clinical settings, including heart failure research and diabetes research.[1][2] The trials focus on practical patient outcomes such as safety events, kidney changes, hospitalisation, death from cardiovascular causes, and HbA1c change.[1][2] This means the research is aimed at understanding how treatment strategies perform in real patient groups with chronic disease.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT05989503 Low Intervention Heart failure with reduced ejection fraction Completed 172
NCT05433584 Phase 3 Type 2 Diabetes Authorised 781

FAQ

  • What conditions are being studied in Saxagliptin trials? The trial data include heart failure with reduced ejection fraction and type 2 diabetes. In one study, Saxagliptin appears in a treatment group for people with heart failure, and in another it appears in a diabetes study.
  • Who may take part in these trials? The trials are for adults with the studied conditions. One trial includes patients with heart failure with reduced ejection fraction, and the other includes adult participants with type 2 diabetes.
  • What phase are the Saxagliptin trials? One study is listed as Low Intervention, which means it is not described as a standard drug-development phase. The diabetes study is Phase 3, which is a later-stage trial that usually compares treatments in larger groups.
  • What are the trials trying to measure? The heart failure trial measures a combined set of safety and disease-worsening events, such as low blood pressure, kidney changes, hospital stay for heart failure, and death from cardiovascular causes. The diabetes trial measures change in HbA1c, which shows average blood sugar over time.
  • Is Saxagliptin the main treatment being tested in these studies? No. In the trial data, Saxagliptin appears as one of several treatment options or background treatments. The studies are mainly testing treatment strategies or comparing different diabetes care approaches.

Ongoing Clinical Trials on Saxagliptin

  • 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 Starting Valsartan, Sacubitril, and Empagliflozin for Patients with Heart Failure with Reduced Ejection Fraction

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Portugal

Glossary

  • Heart failure with reduced ejection fraction (HFrEF): A type of heart failure where the heart does not pump blood as strongly as it should.
  • Type 2 diabetes: A long-term condition where the body does not use blood sugar well, leading to high blood sugar levels.
  • Phase 3: A late stage of clinical research that usually studies a treatment in a larger group of people.
  • Low Intervention: A study design with limited intervention beyond usual care or planned study procedures.
  • Randomized: Participants are assigned to study groups by chance, not by choice.
  • Open-label: A study where participants and researchers know which treatment is being used.
  • HbA1c: A blood test that shows the average blood sugar level over about 2 to 3 months.
  • Composite outcome: A study result that combines several possible events into one main measure.
  • eGFR: An estimate of how well the kidneys are working.
  • Cardiovascular causes: Causes related to the heart and blood vessels.

References