Efficacy and safety of semaglutide once weekly versus insulin glargine once daily as add on to metformin with or without sulphonylurea in insulin-naïve subjects with type 2 diabetes - SUSTAIN* 4 * vs. Basal Insulin

ovo Nordisk0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月23日

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•1. Male or female, age *18 years at the time of signing informed consent;2. Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin *1500 mg or maximum tolerated dose and SU * half of maximum allowed dose according to national label) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose;3. HbA1c 7.0 * 10.0% (53 - 86 mmol/mol) both inclusive

•1. Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period;2. Any disorder which, in the opinion of the Investigator might jeopardise subject*s safety or compliance with the protocol;3. Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (*7 days in total) with insulin in connection with intercurrent illness;4. History of chronic or idiopathic acute pancreatitis;5. Screening calcitonin value *50 ng/L;6. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2;7. Severe renal impairment defined as eGFR <30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version);8. Acute coronary or cerebrovascular event within 90 days before randomisation;9. Heart failure, New York Heart Association Class IV;10. Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator;11. Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)

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ovo Nordisk