NCT02128932已完成3 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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,089
- 试验地点
- 1
- 主要终点
- Change in HbA1c From Baseline
研究概览
简要总结
This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years or older at the time of signing informed consent
- •Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
- •HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
排除标准
- •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 subject'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 or less in total) with insulin in connection with intercurrent illness
- •History of chronic or idiopathic acute pancreatitis
- •Screening calcitonin value greater than or equal to 50 ng/L
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
- •Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
- •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
研究组 & 干预措施
Semaglutide 0.5 mg/week
Experimental
干预措施: semaglutide (Drug)
Semaglutide 1.0 mg/week
Experimental
干预措施: semaglutide (Drug)
Insulin glargine
Active Comparator
干预措施: insulin glargine (Drug)
结局指标
主要结局
Change in HbA1c From Baseline
时间窗: Week 0, week 30
Change in HbA1c from baseline to week 30.
次要结局
- Change in Body Weight From Baseline(Week 0, week 30)
- Change in Fasting Plasma Glucose From Baseline(Week 0, week 30)
- Change in Diastolic Blood Pressure.(Week 0, week 30)
- Change in Systolic Blood Pressure.(Week 0, week 30)
- Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™(Week 0, week 30)
- Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs)(Week 0, week 30)
- Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE)(After 30 weeks treatment)
研究者
研究点 (1)
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