This study is looking at people with type 2 diabetes whose blood sugar levels are not well controlled with their current medication. Type 2 diabetes is a condition where the body does not properly use insulin, a hormone that helps control blood sugar levels. The study will test different combinations and doses of medications given as injections under the skin. These medications include cagrilintide, semaglutide, a combination of both called CagriSema, and placebo. Some participants may also continue taking their regular diabetes medications, which could include metformin taken by mouth, with or without a type of medication called an SGLT2 inhibitor such as dapagliflozin.
The main goal of the study is to see how well CagriSema works at lowering blood sugar levels compared to semaglutide alone, as measured by a blood test called HbA1c that shows average blood sugar over several months. The study will also look at how these medications affect body weight, blood pressure, cholesterol levels, and other health measurements. Researchers want to understand if the combination medication works better than the individual medications at helping people reach target blood sugar levels and lose weight. The study will also measure how much time blood sugar levels stay within a healthy range using a continuous glucose monitor, which is a small device that tracks sugar levels throughout the day.
Participants will receive their assigned treatment for 68 weeks, with the entire study lasting about 75 weeks. During this time, they will have regular visits to check their blood sugar, weight, blood pressure, and overall health. The study will also ask participants questions about their quality of life and satisfaction with their diabetes treatment. Safety will be carefully monitored throughout the study, including checking for side effects and episodes of low blood sugar, which can occur when blood sugar drops too low and may cause symptoms like shakiness or confusion.
1Treatment period begins
The treatment period starts at week 0, which serves as the baseline for all measurements.
At this point, initial measurements will be taken, including HbA1c (a blood test that shows average blood sugar levels over the past 2-3 months), body weight, waist circumference, blood pressure, and blood samples for cholesterol and other fats in the blood.
A device called a continuous glucose monitor (a small sensor that measures sugar levels in the blood throughout the day and night) will be used starting from week -3 to collect baseline data.
Several questionnaires will be completed to assess quality of life and satisfaction with diabetes treatment.
2Receiving assigned treatment
One of the following treatment options will be assigned: CagriSema (a combination of cagrilintide and semaglutide) at doses of 2.4 mg/2.4 mg or 1.0 mg/1.0 mg, semaglutide alone at 2.4 mg or 1.0 mg, cagrilintide alone at 2.4 mg, or placebo (an inactive substance with no medication).
The assigned medication will be administered as an injection under the skin (subcutaneous injection) once weekly.
Current diabetes medications (metformin taken by mouth and possibly an SGLT2 inhibitor, which is a type of diabetes medication that helps remove sugar through urine, also taken by mouth) will be continued at the same stable dose throughout the trial.
3Ongoing treatment and monitoring
The treatment will continue for 68 weeks.
Regular visits will occur throughout this period to monitor progress and safety.
Blood sugar levels will be continuously monitored using the continuous glucose monitor device.
Any side effects or health changes will be recorded and assessed during the treatment period.
Blood pressure will be measured regularly, including both systolic blood pressure (the pressure when the heart beats) and diastolic blood pressure (the pressure when the heart rests between beats).
4End of treatment assessments
At week 68, final treatment measurements will be taken.
These measurements include HbA1c, body weight, waist circumference, blood pressure, and blood samples for fats such as triglycerides (a type of fat in the blood), total cholesterol, HDL cholesterol (good cholesterol), LDL cholesterol (bad cholesterol), VLDL cholesterol (another type of cholesterol), non-HDL cholesterol, and free fatty acids.
Blood samples will also be taken to measure fasting plasma glucose (blood sugar level after not eating overnight) and high sensitivity C-reactive protein (a marker of inflammation in the body).
The continuous glucose monitor data will be analyzed to determine time spent in different blood sugar ranges: tight target range (3.9-7.8 mmol/L or 70-140 mg/dL), target range (3.9-10.0 mmol/L or 70-180 mg/dL), above range (over 10.0 mmol/L or over 180 mg/dL, and over 13.9 mmol/L or over 250 mg/dL).
The within-day glycaemic variability (how much blood sugar levels fluctuate during a single day) will be calculated.
Quality of life questionnaires will be completed again, including the SF-36v2 (a general health survey), Diabetes Treatment Satisfaction Questionnaire, and Treatment Related Impact Measure for Diabetes.
5Follow-up period
After treatment ends at week 68, a follow-up period of 7 weeks will occur.
The study will be completed at week 75.
During this follow-up period, any remaining side effects or health changes will continue to be monitored and recorded.
Any episodes of hypoglycaemia (low blood sugar) will be documented, including clinically significant hypoglycaemia (blood sugar below 3.0 mmol/L or 54 mg/dL confirmed by a blood glucose meter) and severe hypoglycaemia (low blood sugar causing confusion or loss of consciousness requiring assistance from another person).
Who Can Join the Study?
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.
You must have been diagnosed with type 2 diabetes, which is a condition where your body does not use insulin properly and your blood sugar levels are too high, at least 180 days (about 6 months) before joining the study.
You must have been taking the same daily dose of diabetes medication for at least 90 days (about 3 months) before joining the study. This medication must be metformin, which is a common diabetes medicine that helps lower blood sugar, either alone or combined with SGLT2 inhibitors, which are medicines that help your kidneys remove sugar through urine. Your doctor must consider your dose to be effective or the highest dose you can tolerate.
Your HbA1c level must be between 7.0% and 10.5%. HbA1c is a blood test that shows your average blood sugar levels over the past 2 to 3 months. This will be measured by a laboratory when you are screened for the study.
Your BMI must be 25 or higher at the time of screening. BMI stands for Body Mass Index, which is a number calculated from your height and weight that indicates if you are underweight, normal weight, overweight, or obese.
Who Cannot Join the Study?
The source data does not provide specific exclusion criteria, which are the reasons why a patient cannot participate in the study
Without detailed information about who cannot join this trial, it is not possible to list the specific conditions or situations that would prevent participation
Typically, exclusion criteria may include things like other health conditions, certain medications being taken, recent medical procedures, or laboratory test results that fall outside acceptable ranges, but these specific details are not available in the provided information
CagriSema is a combination medication that contains two medicines given together: cagrilintide and semaglutide. This medication is given as an injection under the skin once a week. It is being tested to help people with type 2 diabetes lower their blood sugar levels when metformin alone or metformin with another diabetes medicine is not working well enough.
Semaglutide is a medication used to treat type 2 diabetes. It is given as an injection under the skin once a week. This medicine helps lower blood sugar levels and may also help with weight loss. In this study, it is being compared to the combination medication to see which works better.
Cagrilintide is a medication being studied for the treatment of type 2 diabetes. It is given as an injection under the skin once a week. This medicine works to help control blood sugar levels in people with diabetes.
Metformin is a commonly used pill for treating type 2 diabetes. It helps lower blood sugar levels by reducing the amount of sugar made by the liver and helping the body use insulin better. All participants in this study are already taking this medication.
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 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 levels of glucose in the blood, which can affect various body systems if not properly managed.
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