Hyperglycemia and Its Effect After Acute Myocardial Infarction on Cardiovascular Outcomes in Patients With Type 2 Diabetes (HEART2D)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,116
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced a Primary Combined Outcome
研究概览
简要总结
The primary objective was to demonstrate a difference between two insulin strategies, one targeting postprandial (PP) hyperglycemia and the other targeting fasting and interprandial hyperglycemia, on time until the first combined adjudicated cardiovascular (CV) event (primary outcome defined as CV death, nonfatal myocardial infarction [MI], nonfatal stroke, coronary revascularization, or hospitalized acute coronary syndrome).
详细描述
The purpose of this study is to evaluate the effect of two different treatment strategies on CV outcomes in patients with type 2 diabetes while aiming to achieve and maintain HbA1c <7.0% in both groups. Only patients who have recently experienced an acute MI will be considered for participation in this trial.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are at least 30 years old
- •Have had type 2 diabetes for at least 3 months prior to Visit 1
- •Were admitted to the Coronary Care Unit (CCU) within 18 days prior to Visit 1 for an acute MI
- •Are capable and willing to do specified study procedures
- •Have given informed consent to participate in the study in accordance with local regulations
排除标准
- •Were on one of the following therapies prior to admission to the CCU for the recent MI: a)diet therapy only and have glycosylated hemoglobin (HbA1c) <1.15 times the upper limit of normal or b) an intensive basal/bolus insulin regimen
- •Are using any oral antihyperglycemic medication at the time of Visit 2 and are unwilling to stop the use of such medication for the duration of the study
- •Have substantial myocardial damage, which would significantly outweigh the potential benefit of the treatment strategies for diabetes
- •Have the most severe form of congestive heart failure
- •Have liver disease so severe that it precludes the patient from following and completing the protocol
研究组 & 干预措施
1
Postprandial: Premeal insulin lispro +/- bedtime NPH
干预措施: Insulin lispro (Drug)
1
Postprandial: Premeal insulin lispro +/- bedtime NPH
干预措施: Human insulin isophane suspension (NPH) (Drug)
2
Fasting: NPH/insulin glargine or human insulin 30/70
干预措施: Insulin glargine (Drug)
2
Fasting: NPH/insulin glargine or human insulin 30/70
干预措施: Human insulin isophane suspension (Drug)
2
Fasting: NPH/insulin glargine or human insulin 30/70
干预措施: Human insulin 30/70 (Drug)
结局指标
主要结局
Number of Participants Who Experienced a Primary Combined Outcome
时间窗: Randomization (Day 0) until first occurrence of primary combined outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years)
The combined study outcomes consisted of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, hospitalization for acute coronary syndromes (HACS), and coronary revascularization procedures planned after randomization.
次要结局
- Number of Participants Who Experienced Congestive Heart Failure(Randomization (Day 0) until congestive heart failure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years))
- Number of Participants Who Experienced Revascularization Procedure for Peripheral Vascular Disease Planned After Randomization(Randomization (Day 0) until revascularization procedure (18 month initial treatment period, extended treatment follow-up period up to 5.5 years))
- Number of Participants Who Experienced Death From Any Cause or Any One of the Primary Outcomes(Randomization (Day 0) until death from any cause or one of the primary outcomes (18 month initial treatment period, extended treatment follow-up period up to 5.5 years))
- Number of Participants Who Experienced Any One of the Primary Outcomes Adjusted for Indicators of Metabolic Control(Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years))
- Number of Participants Who Experienced Primary Outcomes Adjusted for Metabolic Control and Major Cardiovascular (CV) Risk Factors(Randomization (Day 0) until occurrence of primary outcome (18 month initial treatment period, extended treatment follow-up period up to 5.5 years))
- Number of Participants Who Experienced Death From Any Cause(Randomization (Day 0) until death from any cause (18 month initial treatment period, extended treatment follow-up period up to 5.5 years))
- Number of Participants Who Experienced Cardiovascular (CV) Death(Randomization (Day 0) until cardiovascular death (18 month initial treatment period, extended treatment follow-up period up to 5.5 years))
- Number of Participants Who Experienced Myocardial Infarction (MI)(Randomization (Day 0) until myocardial infarction (18 month initial treatment period, extended treatment follow-up period up to 5.5 years))
- Number of Participants Who Experienced Stroke(Randomization (Day 0) until stroke (18 month initial treatment period, extended treatment follow-up period up to 5.5 years))
- Number of Participants Who Experienced Hospitalization for Acute Coronary Syndromes (HACS)(Randomization (Day 0) until HACS (18 month initial treatment period, extended treatment follow-up period up to 5.5 years))
- Number of Participants Who Experienced Coronary Revascularization Procedures(Randomization (Day 0) until coronary revascularization procedures (18 month initial treatment period, extended treatment follow-up period up to 5.5 years))
- Number of Participants Who Experienced Amputation for Peripheral Vascular Disease Planned After Randomization(Randomization (Day 0) until amputation (18 month initial treatment period, extended treatment follow-up period up to 5.5 years))
- Number of Participants Who Experienced Coronary Angiography Planned After Randomization(Randomization (Day 0) until coronary angiography (18 month initial treatment period, extended treatment follow-up period up to 5.5 years))
- Number of Participants With Self-Reported Hypoglycemia During Month 1(Visit 3 (Month 1))
- Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 1(Visit 3 (Month 1))
- Number of Participants With Self-Reported Hypoglycemia During Month 3(Visit 4 (Month 3))
- Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 3(Visit 4 (Month 3))
- Number of Participants With Self-Reported Hypoglycemia During Month 6(Visit 5 (Month 6))
- Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 6(Visit 5 (Month 6))
- Number of Participants With Self-Reported Hypoglycemia During Month 9(Visit 6 (Month 9))
- Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 9(Visit 6 (Month 9))
- Number of Participants With Self-Reported Hypoglycemia During Month 12(Visit 7 (Month 12))
- Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 12(Visit 7 (Month 12))
- Number of Participants With Self-Reported Hypoglycemia During Month 18(Visit 8 (Month 18))
- Number of Episodes of Self-Reported Hypoglycemia Reported by Participants With Self-Reported Hypoglycemia During Month 18(Visit 8 (Month 18))