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Study on the Effects of Switching from Daily Basal Insulin to Weekly Insulin Icodec Compared to Daily Insulin Glargine in Adults with Type 2 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 is focused on studying the effects of a new treatment for Type 2 Diabetes, a condition where the body does not use insulin properly, leading to high blood sugar levels. The study will compare a new weekly insulin called insulin icodec with a commonly used daily insulin known as insulin glargine. Insulin icodec is administered once a week using a special pen-injector, while insulin glargine is given daily through a pre-filled pen.

The purpose of the study is to see how well the new weekly insulin helps in controlling blood sugar levels compared to the daily insulin. Participants in the study will switch from their current daily insulin to either the weekly insulin icodec or continue with the daily insulin glargine. The study will last for 26 weeks, during which participants will receive regular injections and have their blood sugar levels monitored.

Throughout the study, researchers will observe changes in blood sugar control, as well as any side effects or safety concerns. The goal is to determine if the weekly insulin is as effective as the daily insulin in managing blood sugar levels in adults with Type 2 Diabetes. Participants will also be asked about their satisfaction with the treatment to understand how the new insulin fits into their daily lives.

The research process

The trial runs in 5 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, the participant will be assessed to ensure they meet the inclusion criteria. This includes having been diagnosed with Type 2 Diabetes for at least 180 days, having an HbA1c level between 7.0% and 10.0%, and having been treated with basal insulin for at least 90 days prior to the study.
Step 2
Initial assessment
An initial assessment will be conducted to establish baseline measurements. This includes measuring HbA1c levels, body weight, and other relevant health indicators.
Step 3
Treatment phase
Participants will be randomly assigned to receive either insulin icodec or insulin glargine. Insulin icodec is administered once weekly at a concentration of 700 U/mL, while insulin glargine is administered once daily at a concentration of 100 units/mL.
The treatment phase will last for 26 weeks. During this time, participants will continue their usual non-insulin anti-diabetic medications, if applicable.
Step 4
Monitoring and follow-up
Participants will attend regular follow-up visits to monitor their health and the effectiveness of the treatment. This includes measuring changes in HbA1c levels, time spent in target blood sugar range, and any hypoglycemic episodes.
Participants will also complete the Diabetes Treatment Satisfaction Questionnaire to assess their satisfaction with the treatment.
Step 5
End of study assessment
At the end of the 26-week treatment period, a final assessment will be conducted. This will include measuring changes in HbA1c levels, body weight, and other health indicators compared to baseline measurements.

Who can join the trial?

6 criteria

Must have been diagnosed with Type 2 Diabetes at least 180 days before the screening day.
Must have an HbA1c level between 7.0% and 10.0% at screening. HbA1c is a blood test that shows your average blood sugar levels over the past 2 to 3 months.
Must have been treated with once-daily or twice-daily basal insulin for at least 90 days before screening. Basal insulin is a type of insulin that helps control blood sugar levels throughout the day and night.
Can be taking other anti-diabetic medications, such as metformin or sulfonylureas, as long as the doses have been stable for at least 90 days before screening.
Must 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.
Both males and females are eligible to participate.

Who cannot join the trial?

5 criteria

Patients who have a different type of diabetes other than Type 2 Diabetes cannot participate.
Patients who are not currently using a daily basal insulin are excluded. Basal insulin is a type of insulin that helps control blood sugar levels throughout the day and night.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study but is not specified here.
Patients who are part of a vulnerable population, which may include groups like pregnant women or those with certain health conditions, are excluded.
Patients who are not able to switch from their current insulin to the study insulin as required by the trial cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Diagnostic-consultative center “Aleksandrovska” EOOD
Verified
Sofia, Bulgaria
Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital Universitario Quironsalud Madrid
Verified
Pozuelo De Alarcon, Spain

Trial locations

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Investigated drugs

Insulin Icodec
is a new type of insulin that is taken once a week. It is being studied to see how well it controls blood sugar levels in people with type 2 diabetes who are switching from their daily insulin. The goal is to find out if it works as well as other daily insulin treatments.
Insulin Glargine U100
is a long-acting insulin that is taken once a day. It is used to help control blood sugar levels in people with type 2 diabetes. In this study, it is being compared to the new once-weekly insulin to see if the new treatment is just as effective.

What is already known about the treatment

Insulin Icodec
This medication is administered as a once-weekly injection and is currently being studied for its effectiveness and safety in managing Type 2 Diabetes. It is in the clinical trial phase, with research focusing on its ability to control blood sugar levels when switching from daily basal insulins. The main therapeutic indication is for the treatment of Type 2 Diabetes. Insulin Icodec works by mimicking the action of natural insulin, helping cells absorb glucose from the blood, thus lowering blood sugar levels. It is classified as a long-acting insulin analog.
Insulin Glargine U100
This medication is administered as a once-daily injection and is well-established in medical practice for managing Type 2 Diabetes. It is being compared to Insulin Icodec in clinical trials to evaluate its efficacy in maintaining blood sugar control. The primary therapeutic use is for the treatment of Type 2 Diabetes. Insulin Glargine U100 functions by providing a steady level of insulin, helping to regulate blood sugar levels over a 24-hour period. It is classified as a long-acting insulin analog.

Investigated diseases

Type 2 Diabetes – This is a chronic condition that affects the way the body processes blood sugar (glucose). In type 2 diabetes, the body either resists the effects of insulin, a hormone that regulates the movement of sugar into cells, or doesn't produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can lead to various complications, affecting the heart, kidneys, nerves, and eyes. The disease often develops slowly, and individuals may not notice symptoms initially. Common symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. Lifestyle factors such as obesity and inactivity are significant contributors to the development of type 2 diabetes.