A long-term, randomised, double-blind, placebo-controlled, multinational, multi-centre trial to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes - SUSTAIN™ 6 – Long term outcomes

ovo Nordisk A/S0 个研究点目标入组 3,260 人开始时间: 2013年4月23日最近更新: 2016年3月14日

适应症

试验速览

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•- Men and women with type 2 diabetes mellitus.
•- Age =50 years at screening and clinical evidence of cardiovascular disease or age =60 years at screening and subclinical evidence of cardiovascular disease.
•- Anti-diabetic drug naïve, or treated with one or two OAD(s), or treated with human NPH insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OAD(s).
•- HbA1c =7.0% at screening.
•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 1630
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1630

•- Type 1 diabetes mellitus.
•- Use of GLP-1 receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening.
•- Use of any DPP-IV inhibitor within 30 days prior to screening.
•- Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness.
•- Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening.
•- History of chronic pancreatitis or idiopathic acute pancreatitis.
•- An acute coronary or cerebro-vascular event within the previous 14 days from Visit 2.
•- Currently planned coronary, carotid or peripheral artery revascularisation.
•- Chronic heart failure NYHA class IV.
•- Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma.
•- Personal history of non-familial medullary thyroid carcinoma.
•- Screening calcitonin =50 ng/L.

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