Effect of Lantus and Apidra in Patients With Acute ST Elevation Myocardial Infarction (INTENSIVE)

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.