NCT01720446已完成3 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,297
- 试验地点
- 1
- 主要终点
- Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke
研究概览
简要总结
This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with type 2 diabetes mellitus - Age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and subclinical evidence of cardiovascular disease - Anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OADs - HbA1c above or equal to 7.0% at screening
排除标准
- •Type 1 diabetes mellitus - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening - Use of any dipeptidyl peptidase 4 (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 - Acute coronary or cerebro-vascular event within 90 days prior to randomisation - Currently planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure New York Heart Association (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 above or equal to 50 ng/L
研究组 & 干预措施
Semaglutide 0.5 mg
Experimental
干预措施: semaglutide (Drug)
Semaglutide 1.0 mg
Experimental
干预措施: semaglutide (Drug)
Semaglutide placebo 0.5 mg
Placebo Comparator
干预措施: placebo (Drug)
Semaglutide placebo 1.0 mg
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke
时间窗: Time from randomisation up to end of follow-up (scheduled at week 109)
Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.
次要结局
- Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose(Week 0, up to week 104)
- Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome(Time from randomisation up to end of follow-up (scheduled at week 109))
- Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome(Time from randomisation up to end of follow-up (scheduled at week 109))
- Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke(Time from randomisation up to end of follow-up (scheduled at week 109))
- Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)(Week 0, up to week 104)
- Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio(Week 0, up to week 104)
- Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)(Week 0, up to week 104)
- Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight(Week 0, up to week 104)
- Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile(Week 0, up to week 104)
- Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs(Week 0, up to week 104)
- Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events(Week 0 - 109)
- Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)(Week 0, up to week 104)
- Incidence During the Trial in Other Treatment Outcomes: Adverse Events(Weeks 0-109)
- Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies(Weeks 0-109)
- Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)(Week 0, up to week 104)
研究者
研究点 (1)
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