A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT06065540
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 2700
Inclusion Criteria:<br><br> - Male or female.<br><br> - Age 18 years or above at the time of signing the informed consent.<br><br> - Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before<br> screening.<br><br> - Stable daily dose(s) greater than or equal to 90 days before screening of any of the<br> following antidiabetic drug(s) or combination regimen(s) at effective or maximum<br> tolerated dose as judged by the investigator: metformin with or without<br> Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors.<br><br> - Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole [mmol/mol])<br> (both inclusive) as determined by central laboratory at screening.<br><br> - Body Mass Index (BMI) greater than or equal to 25 kilogram per square metre (<br> kg/m^2) at screening. BMI will be calculated in the electronic case report form<br> (eCRF) based on height and body weight at screening.<br><br>Exclusion Criteria:<br><br> - Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30<br> milliliters per minute per 1.73 square metre (mL/min/1.73 m^2) as determined by<br> central laboratory at screening.<br><br> - Treatment with any medication for the indication of diabetes or obesity other than<br> stated in the inclusion criteria within 90 days before screening. However, short<br> term insulin treatment for a maximum of 14 consecutive days and prior insulin<br> treatment for gestational diabetes are allowed.<br><br> - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified<br> by a fundus examination performed within 90 days before screening or in the period<br> between screening and randomisation.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Change in glycated haemoglobin (HbA1c);CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Relative change in body weight
- Secondary Outcome Measures
Name Time Method