A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both

To join this study, you need to be an adult, 18 years old or older. You must have been diagnosed with type 2 diabetes at least 6 months ago. Your diabetes should be fairly stable while you're taking metformin, an SGLT2 inhibitor medicine, or both. Also, your recent blood test for average blood sugar (called HbA1c) needs to be within a specific range (between 7.0% and 10.5%). You also need to have a Body Mass Index (BMI) of 30 or higher (this means you are considered obese).

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant, breastfeeding, planning to get pregnant, or are a woman of child-bearing age not using effective contraception. You also can't have severe kidney problems. If you've recently taken other diabetes or weight-loss medicines (other than metformin or SGLT2 inhibitors) in the last 3 months, you wouldn't be eligible. However, short-term insulin use for up to 14 days is sometimes allowed.

Finally, if you have certain severe eye problems related to your diabetes (like rapidly worsening diabetic retinopathy or maculopathy) that haven't been properly checked or are unstable, you wouldn't be able to take part. It's important for the study doctors to make sure it's safe for everyone who joins.

If you decide to take part, you'll be in the study for about 1 year and 4 months. You'll either receive the new medicine, CagriSema, or the comparison medicine, tirzepatide. Which one you get will be decided randomly, like flipping a coin, so neither you nor the doctor can choose. You'll continue taking your current metformin and/or SGLT2 inhibitor.

Throughout the study, you'll have regular visits to the clinic. These visits will involve various assessments, such as blood tests to check your blood sugar and other health markers, measurements of your weight and height, and discussions with the study team about how you're feeling and any side effects. You'll be given your study medicine and instructions on how to use it. There will be careful monitoring to make sure you are safe and that the study is being conducted properly. The exact number of visits and tests will be explained in detail if you are considered for the study.