NCT02692716已完成3 期
A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes
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
- 3,183
- 试验地点
- 1
- 主要终点
- Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: 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 investigate the cardiovascular safety of oral semaglutide in 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
- 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
- •Male or female diagnosed with type 2 diabetes
- •Age at least 50 years at screening and presence of cardiovascular disease, or age at least 60 years at screening and presence of at least one cardiovascular risk factor
排除标准
- •Current or previous (within 90 days prior to screening) treatment with any GLP-1 (glucagon-like peptide-1) receptor agonist, DPP-4 (dipeptidyl peptidase-4) inhibitor or pramlintide
- •Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)
- •History of pancreatitis (acute or chronic)
- •History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
- •Subjects presently classified as being in New York Heart Association (NYHA) Class IV heart failure
- •Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- •Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening
- •Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment (corresponding to eGFR (glomerular filtration rate, estimated) below 30 mL/min/1.73 m^2)
- •History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)
研究组 & 干预措施
Oral semaglutide
Experimental
干预措施: semaglutide (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke
时间窗: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
Number of participants experiencing a first event of a MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.
次要结局
- Time to First AE Leading to Permanent Trial Product Discontinuation(Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.)
- Change in Eye Examination Category(Week -3, End of treatment)
- Change in Systolic and Diastolic Blood Pressure(Week 0, End of treatment)
- Change in Glycosylated Haemoglobin (HbA1c)(Week 0, End of treatment)
- Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, UAP Requiring Hospitalisation or Hospitalisation for Heart Failure(Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.)
- Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint(Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.)
- Change in Pulse Rate(Week 0, End of treatment)
- Time From Randomisation to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, Non-fatal Myocardial Infarction or Nonfatal Stroke(Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.)
- Time From Randomisation to First Occurrence of Fatal or Non-fatal Myocardial Infarction(Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.)
- Change in Body Weight(Week 0, End of treatment)
- Change in LDL-cholesterol - Ratio to Baseline(Week 0, End of treatment)
- Time From Randomisation to First Occurrence of Fatal or Non-fatal Stroke(Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.)
- Time From Randomisation to All-cause Death(Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 5 weeks of follow-up period.)
- Number of Serious Adverse Events(Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.)
- Change in Total Cholesterol - Ratio to Baseline(Week 0, End of treatment)
- Change in HDL-cholesterol - Ratio to Baseline(Week 0, End of treatment)
- Change in Triglycerides - Ratio to Baseline(Week 0, End of treatment)
研究者
研究点 (1)
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