Not recruiting

A study testing cagrilintide and semaglutide compared to placebo in people with type 2 diabetes taking basal insulin with or without metformin

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at type 2 diabetes, a condition where the body does not properly control blood sugar levels. The study will test a combination treatment called cagrilintide semaglutide, which is given as an injection under the skin once a week. This combination treatment will be compared to placebo. People in the study will continue taking their current once-daily basal insulin treatment, which is a type of long-acting insulin that helps control blood sugar throughout the day. Some people may also be taking metformin, which is a medicine taken by mouth to help lower blood sugar. The basal insulin types that may be used include insulin glargine, insulin detemir, insulin degludec, or human insulin.

The purpose of the study is to find out if the combination treatment of cagrilintide semaglutide is better than placebo at lowering blood sugar levels in people with type 2 diabetes who are already using basal insulin with or without metformin. The study will also look at how the treatment affects body weight and other health measures. The main treatment period will last 40 weeks, during which participants will receive either the combination treatment at different dose levels or placebo through weekly injections under the skin.

During the study, doctors will measure blood sugar control by checking HbA1c, which is a blood test that shows average blood sugar levels over the past few months. They will also measure changes in body weight, waist size, blood pressure, and various blood tests including cholesterol and other fats in the blood. The study will track how much insulin participants need to use and whether they experience low blood sugar episodes. Participants will also complete questionnaires about their satisfaction with treatment and their energy levels. Safety will be monitored throughout the study by recording any unwanted effects that occur.

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
Treatment period begins
The treatment period starts at week 0, which is considered the baseline. At this point, measurements of blood sugar levels, body weight, blood pressure, waist circumference, and other health indicators will be recorded.
Your current basal insulin treatment will continue. Basal insulin is a long-acting insulin taken once daily to help control blood sugar levels throughout the day and night.
If you are taking metformin, a medication in tablet form that helps lower blood sugar, you will continue taking it at your current dose.
Step 2
Study medication administration
You will receive injections under the skin once weekly. The medication may be cagrilintide combined with semaglutide (CagriSema) at doses of either 2.4 mg/2.4 mg or 1.0 mg/1.0 mg, or a placebo (an inactive substance with no medication).
These injections are given subcutaneously, which means the medication is injected into the fatty tissue just under the skin.
The weekly injections will continue throughout the entire treatment period of 40 weeks.
Step 3
Ongoing monitoring during treatment
Throughout the 40-week treatment period, regular monitoring will take place to assess how the treatment is affecting your condition.
Measurements will include HbA1c (a blood test that shows your average blood sugar levels over the past 2-3 months), body weight, fasting plasma glucose (blood sugar level after not eating overnight), blood pressure, and waist circumference.
You will be asked to perform 7-point self-monitoring of blood glucose (SMPG), which involves checking your blood sugar levels at seven different times during the day using a blood glucose meter.
Blood samples will be taken to measure various substances in your blood, including cholesterol levels, triglycerides (a type of fat in the blood), inflammatory markers, and hormones related to appetite regulation.
Your daily insulin dose may be adjusted during the treatment period based on your blood sugar levels.
Any side effects or health changes you experience will be recorded throughout the treatment period.
Step 4
End of treatment assessments
At week 40, the active treatment period ends. Final measurements will be taken to compare with your baseline values from week 0.
These assessments will include all the measurements taken during the treatment period, such as HbA1c, body weight, blood pressure, waist circumference, blood glucose levels, and blood tests for cholesterol and other substances.
You will also complete questionnaires about your satisfaction with the diabetes treatment and your quality of life, including energy levels and physical and mental well-being.
Step 5
Follow-up period
After the treatment period ends at week 40, there is a 7-week follow-up period.
During this time, monitoring will continue to assess any side effects or health changes that may occur after stopping the study medication.
Particular attention will be given to episodes of hypoglycaemia (low blood sugar), which can cause symptoms such as shakiness, sweating, confusion, or dizziness.

Who can join the trial?

7 criteria

You must be male or female, based on sex assigned at birth.
You must be 18 years of age or older at the time you sign the consent form to join the study.
You must have been diagnosed with type 2 diabetes, which is a condition where your body does not use insulin properly to control blood sugar levels, at least 180 days (about 6 months) before the screening visit.
You must be taking a stable dose of basal insulin, which is a long-acting insulin taken once daily to help control blood sugar throughout the day, for at least 90 days (about 3 months) before screening. Your dose must be at least 0.25 units per kilogram of your body weight per day or at least 20 units per day.
You may be taking your basal insulin alone or together with metformin, which is a medicine commonly used to help lower blood sugar levels. If you are taking metformin, it must be at a dose that works well for you or the highest dose you can tolerate, as determined by your doctor.
Your HbA1c level, which is a blood test that shows your average blood sugar control over the past 2 to 3 months, must be between 7.0% and 10.5% at the screening visit.
Your BMI, which stands for body mass index and is a measure of body weight relative to height, must be 25 or higher at the screening visit.

Who cannot join the trial?

3 criteria

The study does not list specific exclusion criteria in the provided information, which means the detailed reasons why patients cannot participate are not available in this document.
Generally, clinical trials have exclusion criteria to ensure patient safety and study accuracy, but these specific details would need to be obtained from the complete study protocol.
Patients interested in this study should discuss their individual medical situation with their doctor to determine if they might be suitable candidates.

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Investigated drugs

Cagrilintide
is an investigational medication being studied for the treatment of type 2 diabetes. It is given as an injection under the skin once a week and is being tested in combination with semaglutide to help improve blood sugar control in people whose diabetes is not well controlled with their current treatment.
Semaglutide
is a medication used to treat type 2 diabetes. It works by helping the body produce more insulin when blood sugar levels are high and by reducing the amount of sugar the liver releases into the blood. In this trial, it is given as an injection under the skin once a week in combination with cagrilintide.
Basal insulin
is a long-acting insulin that participants in this trial are already taking once daily. It provides a steady level of insulin throughout the day to help keep blood sugar levels stable between meals and overnight. Participants continue taking their basal insulin during the trial.
Metformin
is a commonly prescribed oral medication for type 2 diabetes that helps lower blood sugar levels. Some participants in this trial may be taking metformin along with their basal insulin, and they continue taking it during the study if it is part of their treatment.

What is already known about the treatment

Cagrilintide
Cagrilintide is an investigational medication given as a subcutaneous injection (under the skin) once weekly, currently being studied in clinical trials for the treatment of type 2 diabetes. It is being tested in combination with semaglutide to help improve blood sugar control in patients who are not achieving adequate results with basal insulin therapy alone or with metformin. Cagrilintide works by mimicking a natural hormone called amylin, which helps regulate blood sugar levels by slowing down stomach emptying, reducing appetite, and decreasing the release of another hormone called glucagon that raises blood sugar. This medication belongs to the class of amylin analogs and is designed to complement insulin therapy by addressing multiple aspects of blood sugar regulation.
Semaglutide
Semaglutide is a medication administered as a subcutaneous injection (under the skin) once weekly, which is approved for treating type 2 diabetes and is also being studied in combination with cagrilintide in ongoing clinical trials. It helps lower blood sugar levels and promotes weight loss by activating receptors for a natural hormone called GLP-1, which stimulates insulin release when blood sugar is high, reduces the production of glucagon, slows digestion, and decreases appetite. Semaglutide belongs to the pharmacological class known as GLP-1 receptor agonists and has become an important treatment option for patients with type 2 diabetes who need better blood sugar control beyond what basal insulin and metformin can provide. The medication has been widely studied and is recognized in medical literature as an effective therapy for improving glycemic control and supporting weight management.

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, 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 develop, leading to various complications throughout the body. The condition typically develops gradually, often beginning with a state called prediabetes where blood sugar levels are elevated but not yet high enough to be classified as diabetes. Unlike type 1 diabetes, type 2 diabetes is often associated with being overweight and physical inactivity, though genetic factors also play a significant role. The disease progresses as the pancreas becomes less able to produce sufficient insulin and the body's cells become increasingly resistant to insulin's effects.