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A study comparing weekly insulin icodec and semaglutide with daily insulin degludec and insulin aspart in people with type 2 diabetes not well controlled on premixed insulin

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 research study involves people with type 2 diabetes whose blood sugar levels are not well controlled with their current treatment of pre-mixed insulin. The study will compare two different treatments for managing blood sugar. One treatment is called IcoSema, which is a combination of insulin icodec and semaglutide given once a week. The other treatment is Ryzodeg, which is a combination of insulin degludec and insulin aspart given once or twice daily. Both treatments may be used together with oral anti-diabetic drugs, which are diabetes medications taken by mouth. The purpose of the study is to see if the once weekly IcoSema treatment works as well as the daily Ryzodeg treatment in controlling blood sugar levels.

The study will last for 40 weeks. During this time, participants will receive either the weekly IcoSema injection or the daily Ryzodeg injection. The study will measure changes in blood sugar control by looking at a blood test called HbA1c, which shows average blood sugar levels over time. This measurement will be taken at the beginning of the study and again after 40 weeks to see how much it has changed. The study will also look at other factors such as changes in body weight, the number of times blood sugar drops too low (called hypoglycaemic episodes), the amount of insulin needed each week, and how satisfied participants are with their treatment.

Throughout the study, additional information will be collected including blood sugar measurements taken at different times of the day, time spent with blood sugar levels outside the target range, and quality of life scores. The study will also track how the treatment affects daily life and overall wellbeing using questionnaires. Both treatment options will be given as injections under the skin, and the doses may be adjusted during the study to help achieve the best blood sugar control for each participant.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment period begins
Your participation in the study will last for 40 weeks.
You will be assigned to one of two treatment groups. The assignment will be random, meaning it will be determined by chance.
You will receive one of the following treatments: either IcoSema (a combination of insulin icodec and semaglutide) given once weekly, or Ryzodeg (a combination of insulin degludec and insulin aspart) given once or twice daily.
Both medications will be administered as an injection under the skin (subcutaneous injection) using a pre-filled pen.
Step 2
Treatment with IcoSema (if assigned to this group)
You will inject IcoSema once per week for the entire 40-week period.
IcoSema contains two active substances: insulin icodec (a long-acting insulin) and semaglutide (a medication that helps control blood sugar levels).
The injection will be given under the skin using a pre-filled pen.
Your doctor may adjust the dose based on your blood sugar levels throughout the study.
Step 3
Treatment with Ryzodeg (if assigned to this group)
You will inject Ryzodeg once or twice daily for the entire 40-week period.
Ryzodeg contains two types of insulin: insulin degludec (a long-acting insulin) and insulin aspart (a fast-acting insulin).
The injection will be given under the skin using a pre-filled pen.
Your doctor may adjust the dose based on your blood sugar levels throughout the study.
Step 4
Continuation of oral diabetes medications (if applicable)
If you were taking oral anti-diabetic medications before joining the study, you may continue taking them during the trial.
These medications may include metformin, sulfonylureas, meglitinides, DPP-4 inhibitors, sodium-glucose co-transporter 2 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, or combination products containing these medications.
You should continue taking these medications at the same dose you were taking before the study began.
Step 5
Blood sugar monitoring
Throughout the 40-week study period, your blood sugar levels will be monitored regularly.
You will be asked to perform self-monitoring of blood glucose using a blood glucose meter. This involves checking your blood sugar levels at different times of the day.
You will need to measure your blood sugar at seven different time points during the day as instructed.
Some participants may use a continuous glucose monitoring device, which tracks blood sugar levels throughout the day and night.
Step 6
Laboratory tests and measurements
Your HbA1c (a measure of average blood sugar levels over the past 2-3 months) will be measured at the beginning of the study and after 40 weeks.
Your body weight will be measured at the beginning and end of the study to track any changes.
Your fasting plasma glucose (blood sugar level after not eating overnight) will be measured during the study.
Blood samples will be taken at scheduled visits to assess your blood sugar control and safety.
Step 7
Monitoring for low blood sugar episodes
During the study, any episodes of low blood sugar (hypoglycemia) will be recorded.
Clinically significant low blood sugar is defined as a blood sugar level below 3.0 mmol/L (54 mg/dL) confirmed by your blood glucose meter.
Severe low blood sugar refers to episodes where you need assistance from another person to treat the low blood sugar.
You should report any symptoms of low blood sugar, such as shakiness, sweating, confusion, or dizziness.
Step 8
Questionnaires about your experience
You will be asked to complete questionnaires at certain points during the study.
The Diabetes Treatment Satisfaction Questionnaire (DTSQs) will ask about your satisfaction with your diabetes treatment.
The Treatment Related Impact Measure - Diabetes (TRIM-D) will assess how the treatment affects your daily life.
The EQ-5D-5L questionnaire will ask about your overall health and quality of life.
These questionnaires help evaluate how the treatment impacts your well-being and daily activities.
Step 9
End of treatment period
After 40 weeks of treatment, the active study period will end.
Final measurements and assessments will be completed, including blood tests, weight measurement, and questionnaires.
Your doctor will discuss the next steps for your diabetes management after the study concludes.

Who can join the trial?

7 criteria

You can be male or female
You must be 18 years old or older when you sign the consent form to join the study
You must have been diagnosed with Type 2 diabetes for at least 180 days (about 6 months) before the screening visit. Type 2 diabetes is a condition where your body does not use insulin properly, causing high blood sugar levels
Your HbA1c level must be between 7.0% and 10.0% at the screening visit. HbA1c is a blood test that shows your average blood sugar level over the past 2 to 3 months
You must have been taking pre-mixed insulin once or twice daily for at least 90 days (about 3 months) before screening. Pre-mixed insulin is a type of insulin that combines fast-acting and long-acting insulin in one injection. Your dose must be between 20 and 80 units per day, and the insulin must contain 25%, 30%, or 50% of the fast-acting component
You may also be taking certain diabetes pills along with your insulin, as long as you have been on the same dose for at least 90 days before screening. These pills may include: Metformin, which helps lower blood sugar; Sulfonylureas, which help your body make more insulin; Meglitinides, which help control blood sugar after meals; DPP-4 inhibitors, which help regulate blood sugar levels; SGLT2 inhibitors, which help your kidneys remove sugar through urine; Alpha-glucosidase inhibitors, which slow down sugar absorption; Thiazolidinediones, which help your body use insulin better; or combination products containing only these medications
Your body mass index must be 40.0 or less. Body mass index is a measure that uses your height and weight to estimate body fat

Who cannot join the trial?

6 criteria

The study information does not list specific reasons why patients cannot participate in this clinical trial
If you are interested in participating, the research team will review your complete medical history to determine if you are eligible
General factors that often prevent participation in diabetes studies may include having type 1 diabetes (a different form of diabetes where the body produces no insulin), recent serious heart problems, severe kidney or liver disease, or being pregnant or planning to become pregnant
You should inform the study team about all medications you are currently taking, as some drugs may not be compatible with the study treatment
Any history of severe allergic reactions to insulin or similar medications may prevent you from joining
Recent participation in another clinical trial may also be a reason for exclusion

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Verified sites

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Verified
Ko-Med Centra Kliniczne Sp. z o.o.
Zamosc, Poland

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Investigated drugs

IcoSema
is a combination medicine that contains two active substances: insulin icodec and semaglutide. Insulin icodec is a long-acting insulin that helps control blood sugar levels throughout the week, while semaglutide is a medicine that helps your body produce more insulin when blood sugar is high and reduces the amount of sugar your liver makes. This medicine is given as an injection once a week.
Insulin degludec/insulin aspart
is a combination medicine that contains two types of insulin mixed together. Insulin degludec is a long-acting insulin that works throughout the day to keep blood sugar stable, while insulin aspart is a fast-acting insulin that works quickly after meals to control blood sugar spikes. This medicine is given as an injection once or twice daily.

What is already known about the treatment

IcoSema
IcoSema is an injectable medication given once a week under the skin, designed to help control blood sugar levels in people with type 2 diabetes who are not achieving good control with their current insulin treatment. This medication is currently being studied in clinical trials to test if it works as well as other insulin treatments that need to be taken once or twice daily. It combines two active substances that work together: one helps the body release insulin when blood sugar is high and slows down digestion, while the other is a long-acting insulin that helps the body use sugar properly throughout the day. IcoSema belongs to a class of combination diabetes medications that aim to simplify treatment by reducing the number of injections needed each week.
Insulin Degludec/Insulin Aspart
Insulin Degludec/Insulin Aspart is a pre-mixed injectable insulin that combines two types of insulin in one injection, taken once or twice daily under the skin to manage blood sugar levels in people with type 2 diabetes. This medication is already approved and used in medical practice as a standard treatment option for diabetes management. It works by providing both fast-acting insulin that quickly lowers blood sugar after meals and long-acting insulin that keeps blood sugar stable throughout the day and night. This combination insulin belongs to the class of anti-diabetic medications and helps the body's cells absorb sugar from the blood to use as energy.

Investigated diseases

Type 2 Diabetes – Type 2 diabetes is a chronic condition that affects the way the body processes blood sugar, also known as glucose. In this disease, the body either resists the effects of insulin, which is a hormone that regulates the movement of sugar into cells, or does not produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can develop and persist in the bloodstream. The condition typically develops gradually, often over many years, and may go unnoticed in its early stages. As the disease progresses, the body's ability to control blood sugar becomes increasingly impaired. This leads to elevated glucose levels that can affect various organs and systems throughout the body.