Efficacy and safety of semaglutide once-weekly versus exenatide ER 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes - SUSTAIN™ 3 – vs. QW GLP-1

ovo Nordisk A/S0 个研究点目标入组 798 人开始时间: 2013年7月23日最近更新: 2016年1月18日

适应症

试验速览

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•1. Male or female, age = 18 years at the time of signing informed consent
•2. Subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 OADs (Metformin = 1500 mg or maximum tolerated dose and/or TZD and SUs = half of maximum dose allowed according to national label) for at least 90 days prior to screening. Stable is defined as unchanged medication and unchanged dose
•3. HbA1c 7.0 – 10.5 % (53 – 91 mmol/mol) (both inclusive)
•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 639
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 159

•1. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local law or practice)
•2. Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject’s safety or compliance with the protocol
•3. Treatment with 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 inter-current illness
•4. History of chronic or idiopathic acute pancreatitis
•5. Screening calcitonin value = 50 ng/L (pg/mL)
•6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
•7. Impaired renal function defined as eGFR < 60 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 (NYHA) class IV

发起方