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Study on How Insulin Icodec and Semaglutide Help Control Blood Sugar in Patients with Type 2 Diabetes

Verified siteInvestigationalNo 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 is focused on studying the effects of adding a new treatment to help manage blood sugar levels in people with type 2 diabetes. The study involves two medications: semaglutide and insulin icodec. Semaglutide is a solution for injection, and insulin icodec is a new type of insulin that is also given as an injection. Both medications are designed to help control blood sugar levels in patients who need to intensify their diabetes treatment.

The purpose of the study is to investigate how well the combination of semaglutide and insulin icodec can improve blood sugar control in people with type 2 diabetes. Participants will receive these medications through injections under the skin. The study will last for a period of time, during which participants will be monitored to see how their blood sugar levels change. The study will also look at the safety of using these medications together.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to provide valuable information on how these medications can be used together to help people with type 2 diabetes manage their condition more effectively. Participants will be closely observed to ensure their safety and to gather data on how the treatment affects their blood sugar levels and overall health.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the study's purpose and procedures.
You must be at least 18 years old and have been diagnosed with type 2 diabetes for at least 180 days before the study begins.
Step 2
Initial assessment
Your glycated hemoglobin (HbA1c) levels will be measured. These levels should be between 7.5% and 10.5% to qualify for the study.
You will need to have been treated with basal insulin for at least 90 days before the study, without using certain other diabetes medications.
Step 3
Treatment phase
You will receive two medications: semaglutide and insulin icodec. Both are solutions for injection given under the skin.
The study aims to improve your blood sugar control by adding semaglutide to your insulin icodec treatment.
Step 4
Medication administration
You will administer semaglutide and insulin icodec through subcutaneous injections. The exact dosage and frequency will be provided by the study team.
The goal is to achieve an HbA1c level between 6.5% and 7.5%.
Step 5
Monitoring and follow-up
Your blood sugar levels will be regularly monitored through self-measured plasma glucose (SMPG) profiles.
The study will track changes in your HbA1c, fasting plasma glucose, and any hypoglycemic episodes.
Step 6
Completion of the study
The study is expected to end by July 25, 2025. You will be informed about the results and any further steps if necessary.
Your participation will contribute to understanding the effectiveness of combining semaglutide with insulin icodec for managing type 2 diabetes.

Who can join the trial?

9 criteria

Provide informed consent before any study-related activities. This means you agree to participate after understanding the study details.
Be at least 18 years old at the time of signing the informed consent.
Have been diagnosed with Type 2 Diabetes for at least 180 days before the screening day.
Have a Glycated Hemoglobin (HbA1c) level between 7.5% and 10.5% at screening. HbA1c is a measure of your average blood sugar levels over the past 2 to 3 months.
Currently treated with once or twice daily basal insulin (at least 0.25 International Units per kilogram per day or 20 IU per day) without using glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for at least 90 days before screening. Basal insulin is a type of insulin that helps control blood sugar levels throughout the day.
May also be taking other diabetes medications like Metformin, Sulfonylureas, Meglitinides, Dipeptidyl peptidase-4 inhibitors, Sodium-glucose co-transporter-2 inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, or oral combination products, as long as the doses have been stable for at least 90 days before screening.
Have a Body Mass Index (BMI) of 40.0 kg/m² or less. BMI is a measure of body fat based on height and weight.
Need and are willing to undergo treatment intensification with the study treatments to aim for an HbA1c of 6.5% to 7.5%, as assessed by the study doctor.
Be able and willing to follow the study protocol, including performing self-measured plasma glucose (SMPG) profiles as required by the study.

Who cannot join the trial?

9 criteria

Patients with a history of severe allergic reactions to any of the study medications.
Patients who have had a heart attack or stroke in the past 6 months.
Patients with severe kidney disease or on dialysis.
Patients with liver disease that is not well controlled.
Patients who are pregnant, planning to become pregnant, or breastfeeding.
Patients with a history of pancreatitis, which is inflammation of the pancreas.
Patients with a history of certain types of cancer.
Patients who are currently participating in another clinical trial.
Patients with any other medical condition that the study doctor believes would make it unsafe to participate.

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Verified sites

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Institute For Clinical And Experimental Medicine
Prague, Czechia
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Santa Sp. z o.o.
Lodz, Poland

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Investigated drugs

Semaglutide
is a medication used to help control blood sugar levels in people with type 2 diabetes. It works by helping the body release more insulin when blood sugar levels are high, which helps lower blood sugar. In this trial, semaglutide is being added to another diabetes treatment to see if it can improve blood sugar control.
Insulin Icodec
is a type of insulin used to help manage blood sugar levels in people with diabetes. Insulin is a hormone that helps the body use sugar for energy. Insulin icodec is designed to be long-acting, meaning it works over a longer period to help keep blood sugar levels stable. In this trial, insulin icodec is being used alongside semaglutide to see if the combination can better control blood sugar in people with type 2 diabetes.

What is already known about the treatment

Semaglutide – Semaglutide is administered as an injection under the skin, typically once a week. It is currently being studied in combination with insulin icodec for people with type 2 diabetes who need more intensive treatment. The main purpose of semaglutide is to help control blood sugar levels. It works by mimicking a hormone in the body that helps regulate insulin, which lowers blood sugar. Semaglutide is classified as a GLP-1 receptor agonist, a type of medication that helps the body use insulin more effectively.

Investigated diseases

Type 2 Diabetes – Type 2 Diabetes is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body's cells do not respond properly to insulin, and a relative lack of insulin production. Over time, high blood sugar levels can lead to various complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The disease often develops gradually and may initially present with symptoms such as increased thirst, frequent urination, and fatigue. As the condition progresses, individuals may experience more severe symptoms and complications. Management of blood sugar levels is crucial to prevent further progression and complications.