Efficacy and safety of semaglutide once weekly versus insulin glargine once daily as add on to metformin with or without sulphonylurea in insulin-naÃ¯ve subjects with type 2 diabetes - SUSTAIN 4

ovo Nordisk AS0 个研究点目标入组 83 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•Male or female, age >=18 years at the time of signing informed consent
•-Insulin-naÃ¯ve 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
•-HbA1c 7.0 â?? 10.0% (53 - 86 mmol/mol) both inclusive

•-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.
•-Any disorder which, in the opinion of the investigator might jeopardise subjectâ??s safety or
•compliance with the protocol
•-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
•-History of chronic or idiopathic acute pancreatitis
•-Screening calcitonin value >=50 ng/L
•-Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome 2 (MEN2)
•-Acute coronary or cerebrovascular event within 90 days before randomisation
•-Heart failure, New York Heart Association Class IV
•-Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator.
•-Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or
•squamous cell skin cancer)
•-Mental inability, unwillingness or language barrier precluding adequate understanding of or
•compliance with study procedures

发起方

ovo Nordisk AS