CTRI/2018/02/011714Other3 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)
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 3,260
- 试验地点
- 14
- 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 was unable to start in India due to unable to obtain HA approval however this trial has been globally completed on 15 Mar 2016
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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 3.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
- •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
- •An acute coronary or cerebro-vascular event within the previous 14 days from Visit 2 (week 0)
- •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
- •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.
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 (up to max. 148 weeks)
次要结局
- •Incidence during the treatment period in other treatment outcomes: hypoglycaemic events.
- •Occurrence during the treatment period in other treatment outcomes: anti-semaglutide antibodies.(Weeks 0-143)
- •Change from baseline to last assessment during the treatment period in other treatment outcomes: fasting plasma glucose.
- •Change from baseline to last assessment during the treatment period in other treatment outcomes: body weight.
- •Change from baseline to last assessment during the treatment period in other treatment outcomes: glycosylated haemoglobin (HbA1c).
- •Time from randomisation to first occurrence of an expanded composite cardiovascular outcome.
- •Time from randomisation to each individual component of the expanded composite cardiovascular outcome.(Time from randomisation up to end of follow-up (up to max. 148 weeks))
- •Incidence during the treatment period in other treatment outcomes: adverse events.
- •Change from baseline to last assessment during the treatment period in other treatment outcomes: patient reported outcome (PRO).
研究者
研究点 (14)
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