Study on Glucagon and Insulin for Improving Insulin Absorption in Patients with Type 1 Diabetes

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What is this study about?

This clinical trial is focused on studying Diabetes Mellitus type 1, a condition where the body does not produce enough insulin, a hormone that helps control blood sugar levels. The study is investigating a treatment involving glucagon, a protein that can help increase blood sugar levels. The aim is to see if small doses of glucagon, given at the same place as insulin under the skin, can help insulin work better and reduce high blood sugar levels after meals in people with type 1 diabetes.

The purpose of the study is to explore whether this approach can improve insulin absorption and manage blood sugar levels more effectively. Participants will receive either the glucagon treatment or a placebo, and the study will monitor how their blood sugar levels respond over a short period. The treatment is administered subcutaneously, meaning it is injected just under the skin.

Throughout the study, various measurements will be taken to understand how the body processes insulin and glucagon. These include monitoring blood sugar levels and using special cameras and devices to assess how well the treatment is working. The study is expected to continue until the end of 2024, providing valuable insights into managing type 1 diabetes more effectively.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on criteria such as having type 1 diabetes for at least one year, being between 18 and 70 years old, and having a recent HbA1c level below 10.0%.

You will also need to be currently using either a continuous subcutaneous insulin infusion (CSII) via an insulin pump or multiple daily insulin injections (MDII).

2 medication administration

During the trial, you will receive **glucagon** in micro-doses. This will be administered subcutaneously, which means it will be injected under the skin at the same site where you receive your insulin.

The purpose of this is to see if it enhances the absorption of insulin and helps in reducing blood sugar spikes after meals.

3 monitoring and measurements

Throughout the trial, your blood sugar levels will be closely monitored. This includes measuring the area under the glucose curve for the first 60 minutes after administration.

Additional measurements will be taken over the first three hours, including the area under the insulin and glucagon curves, as well as using thermal camera and laser doppler flowmetry to assess blood flow and skin temperature.

4 follow-up visits

You will have follow-up visits scheduled to assess your response to the treatment and to ensure your safety throughout the trial.

These visits will include discussions about any side effects or changes in your condition, and adjustments to the treatment plan if necessary.

5 end of trial

The trial is expected to conclude by December 31, 2024. At the end of the trial, a final assessment will be conducted to evaluate the overall effects of the treatment on your insulin absorption and blood sugar control.

You will receive information about the results of the trial and any potential next steps regarding your diabetes management.

Who Can Join the Study?

Have been diagnosed with Type 1 Diabetes for at least 1 year.
Be between the ages of 18 and 70 years old.
Have a most recent HbA1c level of less than 86 mmol/mol (which is less than 10.0%). HbA1c is a blood test that shows your average blood sugar levels over the past 2 to 3 months.
Currently using either a continuous subcutaneous insulin infusion (CSII) with an insulin pump or taking multiple daily insulin injections (MDII). Subcutaneous means under the skin.

Who Cannot Join the Study?

Patients who do not have Diabetes mellitus type 1 cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who belong to a vulnerable population cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
St. Olavs Hospital HF	Trondheim	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not recruiting	01.04.2023

Trial locations

Investigated drugs:

Glucagon

Glucagon is a hormone that helps to increase blood sugar levels. In this trial, small amounts of glucagon are used to see if it can help insulin work better. The idea is that by giving glucagon at the same place where insulin is injected, it might help the body absorb insulin more effectively. This could help people with type 1 diabetes manage their blood sugar levels better after eating.

Insulin is a hormone that helps to lower blood sugar levels. People with type 1 diabetes need to take insulin because their bodies do not produce it naturally. In this trial, insulin is given in the usual way, but researchers are testing if using glucagon at the same time can make insulin work faster or more effectively. This could help people with diabetes keep their blood sugar levels more stable, especially after meals.

Diabetes mellitus type 1 – Diabetes mellitus type 1 is a chronic condition where the pancreas produces little or no insulin, a hormone necessary for glucose to enter cells and produce energy. The disease typically begins in childhood or young adulthood, although it can occur at any age. It progresses as the immune system mistakenly attacks and destroys insulin-producing beta cells in the pancreas. This leads to high levels of glucose in the blood, which can cause various symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, the lack of insulin can result in complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The progression of the disease requires careful management of blood sugar levels to prevent complications.

Trial ID:

2022-502455-57-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Glucagon and Insulin for Improving Insulin Absorption in Patients with Type 1 Diabetes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?