Hyperglycemia and Cardiovascular Outcomes With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia; Infarction
Intervention: Insulin lispro; Human insulin isophane suspension (NPH); Insulin glargine; Human insulin isophane suspension; Human insulin 30/70
Intervention description: 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%.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1116.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: diabetes; MI; heart attack

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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