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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on improving treatment for people with Type 1 diabetes. The study examines a new combination of two medications: insulin lispro (Lyumjev) and glucagon. Type 1 diabetes is a condition where the body cannot produce insulin, a hormone necessary for controlling blood sugar levels.

The purpose of this research is to determine if mixing a small amount of glucagon with insulin can help the body absorb insulin more quickly after injection under the skin. The study will use a specially prepared solution that combines Lyumjev (a fast-acting insulin) with glucagon (a hormone that normally increases blood sugar) in specific amounts.

During the study, participants will receive subcutaneous injections of this combined insulin-glucagon solution. The solution contains 50 nanograms of glucagon for each unit of insulin. The treatment period will last up to two days, during which researchers will monitor how quickly the insulin works and how it affects blood sugar levels. The maximum daily dose of insulin will be 20 units, while the maximum amount of glucagon will be 0.5 micrograms.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your participation begins with verification of type 1 diabetes diagnosis of at least one year

    Medical staff will check if your HbA1c level is below 9.0%

    Confirmation that you are using an insulin pump or hybrid artificial pancreas

  2. Step 2

    Treatment preparation

    You will receive a mixture of two medications for subcutaneous injection (injection under the skin):

    - Insulin lispro (Lyumjev 100 units/mL)

    - Glucagon (5 nanograms per unit of insulin)

  3. Step 3

    Treatment administration

    The mixed medication will be administered through subcutaneous injection

    Your blood sugar levels and insulin response will be monitored for 4 hours after injection

    Special attention will be paid to the first 30 minutes after injection

  4. Step 4

    Monitoring period

    Medical staff will measure how your body processes the insulin

    Your glucose (blood sugar) consumption will be tracked

    The total monitoring period will last 4 hours

  5. Step 5

    Study duration

    The study is scheduled to run from January 2025 to June 2025

    Your individual participation time will be determined by the medical staff

Who can join the trial?

5 criteria

  • You must have been diagnosed with Type 1 diabetes for at least one year
  • Your age must be between 18 and 70 years old
  • Your most recent HbA1c (a blood test that measures average blood sugar levels over the past 2-3 months) must be less than 9.0%
  • You must be currently using either an insulin pump (a small device that delivers insulin continuously) or a hybrid artificial pancreas (an automated system that monitors blood sugar and delivers insulin) for your diabetes management
  • Both men and women can participate in this study

Who cannot join the trial?

14 criteria

  • Age below 18 or above 65 years
  • Not having Type 1 diabetes
  • Pregnancy or breastfeeding
  • Having any serious medical conditions that could affect the study results
  • Current participation in other clinical trials
  • History of allergic reactions to insulin or glucagon (a hormone that increases blood sugar)
  • Inability to follow study procedures or provide informed consent
  • Uncontrolled diabetes (frequent high or low blood sugar levels)
  • Significant kidney or liver problems
  • History of severe hypoglycemia (very low blood sugar) in the past 3 months
  • Use of medications that could interfere with the study treatment
  • Active infections or inflammatory conditions
  • History of alcohol or drug abuse
  • Mental health conditions that could affect study participation
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Investigated drugs

  • Insulin

    is a hormone medication used to control blood sugar levels in people with diabetes. In this trial, it is being studied to see how quickly it works when injected under the skin.

  • Glucagon

    is a hormone medication that works opposite to insulin by raising blood sugar levels. In this trial, it is being studied in combination with insulin to see if it can help insulin work more quickly when they are mixed together and injected.

  • Insulin-Glucagon mixture

    is a premixed solution combining both hormones. This experimental combination is being tested to determine if adding small amounts of glucagon to insulin can speed up how quickly the insulin starts working in people with Type 1 diabetes.

What is already known about the treatment

  • Glucagon-Insulin Premix

    A novel investigational combination medication administered via subcutaneous injection, combining insulin with small amounts of glucagon (5 ng glucagon per unit of insulin). This experimental formulation is being studied for Type 1 diabetes treatment to potentially improve insulin absorption speed and enhance glucose metabolism control. The medication works through a dual mechanism where insulin lowers blood glucose while the small glucagon amount appears to accelerate insulin absorption from the injection site. This innovative approach represents a new direction in diabetes management, classified as a combination hormone therapy, though it is currently still in clinical trials and not yet approved for regular medical use.

  • Insulin

    A hormone medication administered through subcutaneous injection that serves as the primary treatment for Type 1 diabetes by lowering blood glucose levels. It works by enabling cells to absorb glucose from the bloodstream and promoting glucose storage in the liver, effectively reducing blood sugar levels. Insulin belongs to the class of peptide hormones and is essential for survival in Type 1 diabetes patients, as their bodies cannot produce this hormone naturally.

Investigated diseases

Type 1 Diabetes - A chronic condition where the body's immune system attacks and destroys insulin-producing cells in the pancreas. This autoimmune disease typically develops during childhood or adolescence, but can occur at any age. The destruction of beta cells leads to insufficient insulin production, causing elevated blood sugar levels. People with this condition cannot produce the insulin needed to regulate blood glucose levels naturally. The body's inability to convert sugar into energy results in high blood glucose levels and requires regular insulin administration. The condition develops gradually but once established, it affects the body's ability to process glucose permanently.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510408-32-02Estimated enrolment30 patientsSponsorSt. Olavs Hospital HF

sourced from the EU Clinical Trials Register and site verification

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