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Study on the Effectiveness of Weekly IcoSema (Insulin Icodec and Semaglutide) vs. Daily Insulin Glargine for Adults with Type 2 Diabetes Not Controlled by Oral Drugs

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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 struggles to regulate blood sugar levels effectively. The study will compare a new weekly medication called IcoSema, which combines two substances, insulin icodec and semaglutide, with a daily medication known as insulin glargine. Participants in the study will have their blood sugar levels monitored to see how well these treatments work in controlling their diabetes.

The purpose of the study is to determine if the weekly IcoSema is more effective than the daily insulin glargine in managing blood sugar levels in people with type 2 diabetes who are not adequately controlled with oral anti-diabetic drugs. The study will last for 40 weeks, during which participants will receive either the weekly or daily treatment. Throughout the study, participants will continue their usual oral diabetes medications, which may include drugs like metformin, pioglitazone, dapagliflozin, and others, unless specified otherwise by the study protocol.

Participants will be monitored for changes in their blood sugar levels, body weight, and overall satisfaction with their diabetes treatment. The study will also track the occurrence of any low blood sugar episodes, known as hypoglycemia, and other health indicators. This research aims to provide valuable insights into the effectiveness and safety of the new weekly treatment option for managing type 2 diabetes.

The research process

The trial runs in 7 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, informed consent is required. This means agreeing to participate after understanding the study's purpose and procedures.
Eligibility is confirmed based on criteria such as age, type 2 diabetes diagnosis, and current treatment with oral anti-diabetic drugs (OADs).
Step 2
Baseline assessment
Initial health assessments are conducted to establish baseline measurements. This includes checking blood sugar levels (HbA1c) and body weight.
Participants must have an HbA1c level of 8.0% or higher to qualify.
Step 3
Randomization and treatment allocation
Participants are randomly assigned to one of two treatment groups: once weekly IcoSema or daily insulin glargine.
IcoSema is a combination of insulin icodec and semaglutide, administered subcutaneously once a week.
Insulin glargine is administered subcutaneously daily using a pre-filled pen.
Step 4
Treatment period
The treatment period lasts for 40 weeks. Participants continue their assigned treatment while maintaining their current OADs, unless otherwise instructed.
Regular monitoring of blood sugar levels and body weight is conducted throughout the study.
Step 5
Continuous glucose monitoring
From week 36 to week 40, participants use a continuous glucose monitoring (CGM) system to track blood sugar levels.
The CGM system helps assess the time spent within target blood sugar ranges.
Step 6
Final assessments
At the end of the 40-week period, final assessments are conducted to measure changes in blood sugar levels (HbA1c) and body weight.
Participants complete a questionnaire to evaluate their satisfaction with the diabetes treatment.
Step 7
Follow-up
A follow-up period extends to week 45 to monitor any hypoglycemic episodes and ensure participant safety.
Participants continue to report any significant changes in their health status.

Who can join the trial?

8 criteria

Provide informed consent before any study-related activities. This means you agree to participate after understanding the study details.
Can be either male or female.
Must 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.
Have an HbA1c level of 8.0% or higher. HbA1c is a blood test that shows your average blood sugar level over the past 2 to 3 months.
Have not used insulin before, except for short-term use (up to 14 days) or for gestational diabetes (diabetes during pregnancy).
Currently taking 1 to 3 oral anti-diabetic drugs (OADs) with stable doses for at least 90 days before screening. These drugs can include Metformin, Sulfonylureas, Meglitinides, DPP 4 inhibitors, Sodium glucose co-transporter 2 inhibitors, Alpha glucosidase inhibitors, Thiazolidinediones, or certain combination products.
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.

Who cannot join the trial?

5 criteria

Patients who do not have Type 2 diabetes cannot participate. Type 2 diabetes is a condition where the body does not use insulin properly, leading to high blood sugar levels.
Patients who are not in the specified age range cannot participate. The age range includes adults and older adults.
Patients who are not male or female cannot participate.
Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection or care.
Patients who are not inadequately controlled with OADs cannot participate. OADs are oral anti-diabetic drugs, which are pills taken to help control blood sugar levels.

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Verified sites

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Verified
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Verified
Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Italy
Responsive
Universita Degli Studi Di Roma La Sapienza
Rome, Italy

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Investigated drugs

IcoSema
is a medication being tested in this study. It is given once a week to help control blood sugar levels in people with type 2 diabetes who are not managing well with their current oral diabetes medications. The goal is to see if IcoSema can better control blood sugar compared to another treatment.
Insulin Glargine
is a long-acting insulin used daily to help manage blood sugar levels in people with type 2 diabetes. In this study, it is being compared to IcoSema to see which one is more effective in controlling blood sugar when oral diabetes medications are not enough.

What is already known about the treatment

IcoSema – IcoSema is administered as a once-weekly injection and is currently being studied for its effectiveness in managing type 2 diabetes. It is in the clinical trial phase, where its efficacy and safety are being compared to daily insulin glargine. The main therapeutic indication for IcoSema is to improve blood sugar control in individuals with type 2 diabetes who are not adequately managed with oral anti-diabetic drugs. At the molecular level, IcoSema works by enhancing insulin sensitivity and promoting better glucose uptake by the body's cells. It is classified pharmacologically as an anti-diabetic medication.

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, including damage to the eyes, kidneys, and nerves. The disease often develops slowly, and individuals may not notice symptoms initially. Common symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. As the condition progresses, it may require lifestyle changes and medication to manage blood sugar levels effectively.