Efficacy and safety of semaglutide 1.0 mg once-weekly versus liraglutide 1.2 mg once-daily as add-on to 1-3 oral anti-diabetic drugs (OADs) in subjects with type 2 diabetes - SUSTAIN 10

ovo Nordisk A/S0 个研究点目标入组 576 人开始时间: 2017年8月10日最近更新: 2018年11月12日

适应症

试验速览

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•- Male or female, age equal to or above 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus. - HbA1c of 7.0-11.0 % (53 - 97 mmol/mol) (both inclusive). - Stable daily dose(s) including any of the following anti-diabetic drug(s) or combination regimens 90 days prior to the day of screening: a) Biguanides (metformin equal to or above 1500 mg or maximum tolerated dose documented in the subject's medical record). b) Sulphonylureas (equal to or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record). c) SGLT-2 inhibitors (equal to or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 470
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 106

•- Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative. - History or presence of pancreatitis (acute or chronic). - History of diabetic ketoacidosis. - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening. - Subjects presently classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening. - Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 ml/min/1.73 m^2 as defined by KDIGO 2012 classification. - Impaired liver function, defined as ALT equal to or above 2.5 times upper normal limit at screening. - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation.

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