At a glance
ClinicalIndex Comparison Record- ✓Age ≥30 years
- ✓Type 2 diabetes for ≥3 months prior to enrollment
- ✓Acute myocardial infarction with CCU admission within 18 days before enrollment
- ✓Capable and willing to perform specified study procedures
- ✕On diet therapy only with HbA1c <1.15× upper limit of normal
- ✕On intensive basal/bolus insulin regimen prior to admission
- ✕Using oral antihyperglycemic medication at Visit 2 and unwilling to discontinue
- ✕Substantial myocardial damage that would outweigh benefit of diabetes treatment strategies
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Hyperglycemia and Its Effect After Acute Myocardial Infarction on Cardiovascular Outcomes in Patients With Type 2 Diabetes (HEART2D)
In Brief
A Phase 4 clinical trial evaluating Insulin lispro, Human insulin isophane suspension (NPH), and 3 other interventions for Diabetes Mellitus, Type 2 and Acute Myocardial Infarction. Completed, enrolled 1,116 participants across 17 sites in 17 countries.
Detailed Summary
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).
Study Details
Timeline
Interventions
Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study
Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values \>8.0%
Insulin glargine injected subcutaneous (SC) once daily in the evening until patient completes study.
Patient adjusted dose, twice daily, injected subcutaneous (SC) before morning and evening meals until patient completes study.
Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values \>8.0%.