Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) s.c. in doses 2.4/2.4 mg and 1.0/1.0 mg once weekly versus semaglutide 2.4 mg and 1.0 mg, cagrilintide 2.4 mg and placebo in participants with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor(NN9388-4896) - REIMAGINE2

Hiroko Nishida0 个研究点目标入组 2,700 人开始时间: 2023年9月27日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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.

发起方

Hiroko Nishida