TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Sitagliptin in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14,671
- 主要终点
- Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population)
研究概览
简要总结
This is a clinical trial designed to assess the cardiovascular outcome of long-term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin in participants with type 2 diabetes mellitus (T2DM) having a history of cardiovascular (CV) disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.
Primary hypothesis A is that sitagliptin, when used as part of usual care, is non-inferior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint of Major Adverse Cardiovascular Event (MACE) plus. If hypothesis A is satisfied: hypothesis B is that sitagliptin, when used as part of usual care, is superior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint.
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
- •Has HbA1c between 6.5% (48 mmol/mol) and 8.0% (64 mmol/mol) on stable dose(s) of antihyperglycemic agent(s), including insulin
- •Has pre-existing cardiovascular disease
排除标准
- •Has a history of type 1 diabetes mellitus or ketoacidosis.
- •Is not able to take sitagliptin
研究组 & 干预措施
Sitagliptin
Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.
干预措施: Sitagliptin (Drug)
Placebo
Placebo to sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population)
时间窗: Up to 5 years
Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.
Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population)
时间窗: Up to 5 years
Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.
次要结局
- Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population)(Up to 5 years)
- Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population)(Up to 5 years)
- Percent Incidence of All-cause Mortality (Intent to Treat Population)(Up to 5 years)
- Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population)(Up to 5 years)
- Change From Baseline in Renal Function Over Time (Per Protocol Population)(Baseline and up to 5 years)
- Percent Incidence of All-cause Mortality (Per Protocol Population)(Up to 5 years)
- Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population)(Up to 5 years)
- Change From Baseline in Renal Function Over Time (Intent to Treat Population)(Baseline and up to 5 years)
- Change From Baseline in HbA1c Over Time (Per Protocol Population)(Baseline and up to 4 years)
- Change From Baseline in HbA1c Over Time (Intent to Treat Population)(Baseline and up to 4 years)
- Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population)(Baseline and up to 5 years)
- Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population)(Baseline and up to 5 years)
- Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population)(Up to 5 years)
- Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population)(Up to 5 years)
- Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population)(Up to 5 years)
- Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population)(Up to 5 years)