EUCTR2013-004392-12-RO进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,082
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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 838
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 209
排除标准
- •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)
- •12. Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
研究者
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