REIMAGINE 2: 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
- Registration Number
- JPRN-jRCT2031230369
- Lead Sponsor
- Hiroko Nishida
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2700
Male or female.
-Age 18 years or above at the time of signing the informed consent.
-Diagnosed with type 2 diabetes mellitus >= 180 days before screening.
-Stable daily dose(s) >= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without SGLT2 inhibitors.
-HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
-BMI >=25 kg/m2 at screening. BMI will be calculated in the eCRF based on height and body weight at screening.
-Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m2 as determined by central laboratory at screening.
-Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
-Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method