A study comparing cagrilintide and semaglutide combination to semaglutide, cagrilintide, and placebo in adults with type 2 diabetes on metformin

Treatment 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.

Receiving 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.

Ongoing 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).

End 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.

Follow-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).