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Insulin Aspart

Clinical trials investigating Insulin Aspart are studying how it is used in different patient groups, especially people with type 2 diabetes and some emergency or heart-related conditions. These trials look at outcomes such as blood sugar control, potassium reduction, and blood vessel function. They also measure safety, effectiveness, and how well different treatment plans work.

Table of contents

Trial overview

These clinical trials study Insulin Aspart in different research settings, mainly in people with type 2 diabetes and in some studies outside diabetes care.[1][2][3]

The trial data show that Insulin Aspart appears in studies about emergency treatment for hyperkalemia, blood sugar control in type 2 diabetes, and blood vessel or heart-related measurements.[1][3][4]

Conditions studied

Hyperkalemia is one of the conditions studied in a Phase 3 emergency trial that compared insulin/dextrose infusion with nebulized salbutamol and a combination treatment in emergency departments.[1]

Several trials focus on type 2 diabetes, including a study of a new hypoglycemic clamp procedure, a study of cardiovascular autonomic neuropathy, and a large study in people with poorly controlled type 2 diabetes.[2][3][6]

Other trials involve heart and vessel conditions such as heart failure with preserved ejection fraction and vasospastic angina, where Insulin Aspart is part of the testing setup for microvascular or vascular function measurements.[4][5]

Study designs and phases

The trials include interventional studies, which means the researchers assign treatments and then measure the results.[1][2][3]

The listed phases range from Phase 1 to Phase 3, showing both early testing and larger confirmatory studies.[1][2][3][4][5][6]

Some studies are marked Completed, while others are Authorised, which means they have been approved to start or are in progress according to the source data.[1][2][3][4][5][6]

Who can participate

Each trial has its own entry rules, but the source data show several main groups: people with type 2 diabetes, people with poorly controlled type 2 diabetes, people with hyperkalemia, and patients with heart-related conditions such as HFpEF or vasospastic angina.[1][2][3][4][5][6]

One pilot study also included people with and without diabetes to build a new hypoglycemic clamp procedure, which is a controlled method used to study recovery from low blood sugar.[2]

Main outcomes measured

The emergency hyperkalemia trial measured the change in serum potassium from baseline to 60 minutes, which shows how well treatment lowers potassium quickly.[1]

The Phase 1 pilot study measured the insulin rate needed to lower plasma glucose from 90 to 70 mg/dL and from 70 to 48 mg/dL, helping researchers understand glucose-lowering responses in a controlled setting.[2]

The cardiovascular autonomic neuropathy trial measured changes in LF:HF ratio, which is a heart rate variability measure, and also looked at progression in CART parameters and glucose variability over 6 months.[3]

The HFpEF trial measured cutaneous vascular conductance, a way to assess skin blood flow and blood vessel response during laser speckle contrast analysis.[4]

The vasospastic angina trial measured the area under the curve for cutaneous microvascular conductance during acetylcholine iontophoresis and the number of daily angina episodes recorded in the ORBITA-app.[5]

The COMBINE 5 trial measured change in HbA1c after 40 weeks to test whether weekly IcoSema was not worse than daily insulin degludec/Insulin Aspart in people with poorly controlled type 2 diabetes.[6]

Key trial details

  • NCT04012138 was a Phase 3 randomized clinical trial in hyperkalemia with 525 participants. It compared insulin/dextrose infusion, nebulized salbutamol, and combination therapy, with the main outcome of potassium change at 60 minutes.[1]
  • 2025-520996-16-00 was a Phase 1 single-center pilot study in Type 2 Diabetes Mellitus with 24 participants. It used NovoRapid in an intravenous infusion setting and measured insulin rates needed to lower plasma glucose in a controlled clamp procedure.[2]
  • 2025-521748-39-00 was a Phase 3 authorised study in type 2 diabetes with 80 participants. It studied SGLT-2 inhibitors and included Insulin Aspart among several treatment options while assessing heart rate variability and cardiovascular autonomic neuropathy progression.[3]
  • NCT06415227 was a Phase 2 authorised study in vasospastic angina with 55 participants. Insulin Aspart appeared in the study procedures used for microvascular testing, and the trial measured angina episodes and microvascular conductance.[5]
  • 2022-501682-45-00 was a Phase 3 completed study in heart failure with preserved ejection fraction with 48 participants. It measured cutaneous vascular conductance during laser speckle contrast analysis and included NovoRapid in the testing process.[4]
  • 2025-521150-42-00 was a Phase 3 completed trial in type 2 diabetes with 680 participants. It compared weekly IcoSema with daily insulin degludec/Insulin Aspart and measured change in HbA1c after 40 weeks.[6]
Trial ID Phase Condition studied Status Enrollment
NCT04012138 Phase 3 Hyperkalemia Completed 525
2025-520996-16-00 Phase 1 Type 2 Diabetes Mellitus Completed 24
2025-521748-39-00 Phase 3 type 2 diabetes Authorised 80
NCT06415227 Phase 2 Unequivocal epicardial and/or microvascular vasospastic angina Authorised 55
2022-501682-45-00 Phase 3 Heart failure with preserved ejection fraction Completed 48
2025-521150-42-00 Phase 3 Type 2 diabetes Completed 680

FAQ

  • What is being studied in clinical trials of Insulin Aspart? The trials are looking at how Insulin Aspart is used in different study settings, such as type 2 diabetes, hyperkalemia, and heart-related microvascular problems. They measure outcomes like blood sugar change, potassium levels, and blood vessel function.
  • Who may take part in these trials? Participants include people with type 2 diabetes, people with poorly controlled type 2 diabetes, people with hyperkalemia in emergency care, and some patients with heart failure or vasospastic angina. Each trial has its own entry rules.
  • What trial phases are listed for Insulin Aspart studies? The trials include Phase 1, Phase 2, and Phase 3 studies. This means the research ranges from early testing to larger studies that compare treatment effects.
  • What outcomes do the trials measure? The main outcomes include change in HbA1c, serum potassium change, plasma glucose change, and measures of microvascular function. Some trials also track angina episodes and heart rate variability.
  • Are all trials focused only on diabetes? No. Several trials involve type 2 diabetes, but one trial studies acute hyperkalemia and others look at heart and blood vessel measures. Insulin Aspart appears in these studies as one of the trial treatments or comparison options.

Ongoing Clinical Trials on Insulin Aspart

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

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on the Effects of Vericiguat on Patients with Vasospastic Angina

    Recruiting

    2 1 1
    Investigated drugs:
    The Netherlands

  • A study comparing weekly insulin icodec and semaglutide with daily insulin degludec and insulin aspart in people with type 2 diabetes not well controlled on premixed insulin

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Study on Insulin Aspart for Recovery from Low Blood Sugar in People with and without Type 2 Diabetes

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

  • Study on Insulin Aspart, Salbutamol, and Glucose for Treating Acute Hyperkalemia in Emergency Department Patients

    Not recruiting

    3 1 1 1
    Investigated drugs:
    France

  • Study on the Effect of Empagliflozin, Acetylcholine Chloride, Insulin Aspart, and Sodium Nitroprusside Dihydrate on Heart Failure with Preserved Ejection Fraction Patients

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Type 2 diabetes: A long-term condition where the body does not use insulin well, which can lead to high blood sugar.
  • Hyperkalemia: A condition with too much potassium in the blood. It can be urgent and may need treatment in the emergency department.
  • Phase 1: An early trial phase that helps researchers learn how a study treatment behaves in people and how it is used in a controlled setting.
  • Phase 2: A trial phase that looks more closely at whether a treatment works and continues to check safety.
  • Phase 3: A later trial phase with more participants that compares treatment effects in larger groups.
  • HbA1c: A blood test that shows average blood sugar control over about 2 to 3 months.
  • Primary outcome: The main result a trial is designed to measure.
  • Enrollment: The number of people planned or included in a trial.
  • Randomized clinical trial: A study where participants are assigned to different treatments by chance.
  • Microvascular function: How well the smallest blood vessels work.
  • Heart rate variability: A measure of changes in the time between heartbeats. It can reflect how the nervous system controls the heart.
  • Non-inferiority: A study goal that checks whether one treatment is not worse than another by more than a set amount.

References

  1. https://clinicaltrials.eu/trial/study-on-insulin-aspart-salbutamol-and-glucose-for-treating-acute-hyperkalemia-in-emergency-department-patients/
  2. https://clinicaltrials.gov/study/2025-520996-16-00
  3. https://clinicaltrials.gov/study/2025-521748-39-00
  4. https://clinicaltrials.gov/study/2022-501682-45-00
  5. https://clinicaltrials.eu/trial/study-on-the-effects-of-vericiguat-on-patients-with-vasospastic-angina/
  6. https://clinicaltrials.gov/study/2025-521150-42-00