Effect of Lantus and Apidra in Patients With Acute ST Elevation Myocardial Infarction
Condition: AMI
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Intervention: Insulin Glargine (LANTUS); Insulin Glulisine (Apidra); Standard Therapy
Intervention description: Subcutaneous insulin glargine was initiated 90 prior to the insulin glulisine infusion discontinuation (i.e. 48 hours after randomization) and titrated as per physician preference to maintain the plasma glucose between 90-130 mg/dL; Prior PCI, subjects received a single IV bolus of insulin glulisine. The dose was 0.025 U/kg based upon patient reported weight.
Then IV insulin glulisine infusion was started within one hour of the IV insulin glulisine bolus and administered at a minimum rate of 2 U/h for 48 hours. The infusion was titrated in order to achieve and maintain the plasma glucose between 90 and 130 mg/dL.; Standard insulin therapy titrated to blood sugar control
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin glulisine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 35 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Primary objective:

      To demonstrate that in hyperglycemic subjects with anterior STEMI (ST Elevation Myocardial
      Infarction) undergoing Percutaneous Coronary Intervention (PCI), tight glycemic control using
      insulin glulisine and insulin glargine, i.e. Intensive Insulin Therapy (IIT), results in
      reducing infarct size at day 60 versus (vs) Standard Glycemic Care (SGC).

      Secondary objectives:

      To demonstrate that tight glycemic control using insulin glulisine and insulin glargine
      reduces markers of inflammation and improves Left Ventricular (LV) function and
      Cardio-Vascular (CV) outcomes from baseline values, in hyperglycemic subjects with STEMI
      undergoing Percutaneous Coronary Intervention (PCI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women = or > 35 years of age presenting to the hospital with hyperglycemia
             (plasma glucose >140 mg/dL) and Primary Anterior wall ST-Elevation Myocardial
             Infarction (AW STEMI)

          -  No history of illicit drug abuse in past year

          -  A minimum of 30 minutes but < or = 6 hours of continuous pain/symptoms immediately
             prior to presentation

          -  Subjects who will undergo primary percutaneous coronary intervention (PCI)

          -  At least 2 contiguous precordial leads demonstrating at least 2 mm of ST-segment
             elevation consistent with anterior wall MI

          -  Signed informed consent and HIPAA documentation (US only) prior to participation in
             the study

          -  Subjects ability and willingness to adhere to and be compliant with study protocol

        Exclusion Criteria:

          -  A prior history of Myocardial Infarction (MI)

          -  Subjects who have received any thrombolytic therapy during the current hospital
             admission

          -  Severe Heart Failure or cardiogenic shock (Killip class 3 or 4) by history or present
             at the time of screening

          -  Subjects with a plasma glucose >400 mg/dL or diabetic ketoacidosis (DKA)

          -  History of Type 1 diabetes

          -  Active bleeding

          -  Active malignancy, chronic or other medical conditions likely to result in death over
             the next one year

          -  Recent hypotension requiring inotropic support in the past 30 days

          -  Participation in another clinical research study in the past 30 days

          -  Pregnant or lactating women (women of childbearing potential must have a negative
             pregnancy test at study entry and a medically approved contraception method)

          -  Unwilling to give informed consent

          -  Subjects directly involved in the conduct of the study

          -  Known hypersensitivity to insulin glargine or glulisine

          -  Contraindication to MRI: a)Intracranial aneurysm clips (Unless the investigator is
             certain that it is made of non-ferromagnetic material such as titanium)b)Intra-orbital
             metal fragments c)Any electrically, magnetically or mechanically activated implants
             (including cardiac pacemakers, biostimulators, neurostimulators, cochlear implants,
             and hearing aids) d)Warning about Gadolinium-based contrast agents (GBCAs) Exposure to
             GBCAs increases the risk for nephrogenic systemic fibrosis (NSF). Therefore the
             following subjects should be excluded from the trial based on a history and/or
             laboratory tests:

               -  acute or chronic severe renal insufficiency (glomerular filtration rate <30
                  mL/min/1.73m2), as calculated by the MDRD (Modification of diet in Renal Disease)
                  equation, or

               -  acute renal insufficiency of any severity

          -  Subjects with blood pressure > or = to 200/110 mmHg at time of randomization

          -  Subjects with a high degree of non-transient AV (Atrio-Ventricular) block

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.