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 With or Without an SGLT2 Inhibitor
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT06221969
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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 = 180 days before screening.<br><br> - Stable daily dose(s) = 90 days before screening of any of the following antidiabetic<br> drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged<br> by the investigator: metformin with or without an sodium-glucose co-transporter-2<br> (SGLT2) inhibitor.<br><br> - HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central<br> laboratory at screening.<br><br> - Body mass index (BMI) of = 30.0 kilogram per square meter (kg/m^2) at screening. BMI<br> will be calculated in the electronic case report form (eCRF) based on height and<br> body weight at screening.<br><br>Exclusion Criteria:<br><br> - Female who is pregnant, breast-feeding or intends to become pregnant or is of<br> childbearing potential and not using a highly effective contraceptive method.<br><br> - Renal impairment with estimated Glomerular Filtration Rate < 30 milliliter per<br> minute per 1.73 square meter (mL/min/1.73 m^2) as determined by central laboratory<br> 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. Pharmacological pupil-dilation is a requirement<br> unless using a digital fundus photography camera specified for non-dilated<br> examination.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in glycated haemoglobin (HbA1c);Relative change in body weight
- Secondary Outcome Measures
Name Time Method