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Insulin Lispro

Clinical trials are studying Insulin Lispro in different patient groups, mainly people with type 1 diabetes and type 2 diabetes. These studies look at how well it works in specific situations, such as after meals, and also compare it with other treatments in other conditions. The trials measure results like blood glucose changes, insulin absorption, and related health outcomes.

Table of Contents

Overview of the clinical trial data

The source data includes four interventional trials studying Insulin Lispro in different settings.[1] These studies range from Phase 1 to Phase 3, which means the research includes early testing, smaller focused studies, and larger comparison trials.[1][2][3][4]

The target conditions are type 1 diabetes, type 2 diabetes, and hyperkalemia.[1][2][3][4] The studies also differ in size, from 20 participants in one early trial to 525 participants in a larger emergency-care trial.[1][4]

Type 1 diabetes studies

Two trials in the source data focus on people with type 1 diabetes.[1][2] One of them is a completed Phase 1 study with 20 participants that compared ultra-rapid-acting insulin, regular insulin, and Humalog after a meal.[1]

This study looked at how gastric emptying affected the best post-meal glucose result.[1] Gastric emptying means how fast food leaves the stomach, and the trial used this to see whether a faster or slower stomach emptying pattern changed which insulin worked best after eating.[1]

The second type 1 diabetes study was Phase 2 and was suspended after planning to enroll 30 participants.[2] It tested whether adding glucagon to Lyumjev could speed insulin absorption and improve glucose metabolism after subcutaneous injection, which means an injection under the skin.[2]

These two studies show different research goals in type 1 diabetes: one focused on meal-related glucose control, and the other focused on whether a combination approach could change how quickly insulin is absorbed and how it affects glucose use.[1][2]

Type 2 diabetes study

One Phase 3 trial studied people with type 2 diabetes and included Insulin Lispro among many treatment options being compared.[3] This study was authorised and planned to enroll 80 participants.[3]

The main goal was to explore whether the cardiovascular effects of SGLT-2 inhibitors are partly linked to the nerves that control the heart, and to study the progression of cardiovascular autonomic neuropathy.[3] Cardiovascular autonomic neuropathy is nerve damage that can affect heart control, and the trial also measured glucose variability over 6 months.[3]

Although Insulin Lispro was listed among the interventions, the trial was not only about this one treatment.[3] It was part of a broader study of several diabetes medicines and their relationship to heart and nerve outcomes.[3]

Hyperkalemia study

Another large Phase 3 trial studied hyperkalemia, which means high potassium in the blood.[4] This was a completed randomized clinical trial with 525 participants in emergency departments.[4]

The study compared insulin/dextrose infusion, nebulized salbutamol, and a combination of both treatments as first-line care to lower potassium at 60 minutes.[4] Insulin Lispro was listed among the insulin products used in the trial interventions, alongside other insulin and glucose treatments.[4]

This trial is important because it studied a fast emergency treatment goal: reducing serum potassium concentration safely and quickly in people who needed urgent care.[4]

Main endpoints and what they mean

The primary outcome is the main result each study is designed to measure.[1][2][3][4] In the type 1 diabetes meal study, the primary endpoint was the proportion of participants who achieved the lowest glucose AUC with the ultra-rapid insulin in certain gastric emptying groups, compared with regular insulin in the opposite groups.[1]

In the glucagon and Lyumjev study, the main endpoints were the area under the glucose consumption curve and the area under the insulin curve during the first 30 minutes.[2] These measurements help show how much glucose was used and how insulin levels changed shortly after treatment.[2]

In the type 2 diabetes trial, the endpoints included a 20% improvement in the LF:HF ratio, which is a heart rate variability measure, and improvement in at least one CART parameter together with better glucose variability over 6 months.[3] These outcomes were used to check nervous system and heart-related effects in diabetes.[3]

In the hyperkalemia study, the primary endpoint was the mean change in serum potassium from baseline to 60 minutes.[4] Serum potassium is the amount of potassium in the blood, and this endpoint shows whether the treatment lowered it within one hour.[4]

What these trials show about research on Insulin Lispro

The trial data show that Insulin Lispro is being studied in very different clinical situations, not just one disease area.[1][2][3][4] In type 1 diabetes, the focus is on post-meal glucose control and insulin absorption.[1][2] In type 2 diabetes, the study is looking at heart-related nerve outcomes and glucose variability.[3] In hyperkalemia, the trial is part of emergency treatment research aimed at lowering potassium quickly.[4]

Across the studies, the main research questions are about how well treatments work, how quickly they act, and what outcomes they change in the body.[1][2][3][4] The source data does not show one single purpose for all trials, but it does show that Insulin Lispro is being used in focused clinical research settings.[1][2][3][4]

Trial ID Phase Condition studied Status Enrollment
2023-509217-37-00 Phase 1 Type 1 Diabetes Completed 20
2023-510408-32-02 Phase 2 Type 1 diabetes Suspended 30
2025-521748-39-00 Phase 3 type 2 diabetes Authorised 80
NCT04012138 Phase 3 Hyperkalemia Completed 525

FAQ

  • Who can take part in clinical trials of Insulin Lispro? The trials in the source data include people with type 1 diabetes, type 2 diabetes, and one study in hyperkalemia. Each study has its own rules for who can join, based on the condition being studied.
  • What are the trials of Insulin Lispro trying to find out? They are studying how Insulin Lispro performs in real trial settings, such as post-meal blood glucose control, insulin absorption, and effects on potassium levels in emergency care. Some trials also compare it with other treatments.
  • What trial phases are included in the data? The source data includes Phase 1, Phase 2, and Phase 3 trials. This means the studies range from early testing to larger trials that compare treatment effects.
  • What conditions are being studied with Insulin Lispro? The trials focus on type 1 diabetes, type 2 diabetes, and hyperkalemia. The studies do not all use Insulin Lispro for the same purpose, so each trial has a different goal.
  • What kinds of results are measured in these trials? The studies measure outcomes such as glucose area under the curve, blood glucose after meals, insulin curve changes, heart rate variability, and serum potassium change. These results help show how the treatment is affecting the body in each study.

Ongoing Clinical Trials on Insulin Lispro

  • 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

  • A study evaluating a combination of glucagon and insulin lispro to improve insulin absorption in adults with Type 1 diabetes

    Not yet recruiting

    2 1 1 1
    Investigated drugs:
    Norway

  • 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 Insulin Lispro and Insulin Human for Managing Blood Sugar After Meals in Type 1 Diabetes Patients with Different Gastric Emptying Rates

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Type 1 diabetes: A condition where the body cannot make enough insulin, so blood sugar must be managed with treatment.
  • Type 2 diabetes: A condition where the body does not use insulin well, which can lead to high blood sugar.
  • Hyperkalemia: A medical term for high potassium in the blood. It can be dangerous and may need urgent treatment.
  • Phase 1: An early clinical trial phase that usually studies a treatment in a small group of people.
  • Phase 2: A trial phase that looks more closely at whether a treatment works and continues to check safety.
  • Phase 3: A larger trial phase that compares treatments and confirms benefits in bigger patient groups.
  • Enrollment: The number of people planned or included in a clinical trial.
  • Primary outcome: The main result the trial is designed to measure.
  • Area under the curve (AUC): A way to measure the total amount of a change over time, such as glucose levels after treatment.
  • Gastric emptying: How fast food leaves the stomach and moves into the intestine.
  • Heart rate variability (HRV): A measure of small changes in the time between heartbeats. It can reflect how the nervous system affects the heart.
  • CART parameter: A test result used in cardiovascular autonomic reflex testing, which checks how the nerves control the heart and blood vessels.

References

  1. https://clinicaltrials.gov/study/2023-509217-37-00
  2. https://clinicaltrials.gov/study/2023-510408-32-02
  3. https://clinicaltrials.gov/study/2025-521748-39-00
  4. https://clinicaltrials.eu/trial/study-on-insulin-aspart-salbutamol-and-glucose-for-treating-acute-hyperkalemia-in-emergency-department-patients/