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

NCT ID: NCT00670228

Last Updated: 2011-02-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-11-30

Brief 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).

Conditions

AMI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intensive Insulin Therapy (IIT)

In IIT arm, subjects received intravenous (IV) insulin glulisine and subcutaneous (sc) insulin glargine to maintain a Blood Glucose (BG) concentration between 90-130 mg/dL.

Group Type: ACTIVE_COMPARATOR

Insulin Glargine (LANTUS)

Intervention Type: DRUG

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

Insulin Glulisine (Apidra)

Intervention Type: DRUG

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 Glycemic Care (SGC)

In SGC arm subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.

Group Type: ACTIVE_COMPARATOR

Standard Therapy

Intervention Type: DRUG

Standard insulin therapy titrated to blood sugar control

Interventions

Insulin Glargine (LANTUS)

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

Intervention Type: DRUG

Insulin Glulisine (Apidra)

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.

Intervention Type: DRUG

Standard Therapy

Standard insulin therapy titrated to blood sugar control

Intervention Type: DRUG

Other Intervention Names

multiple insulins per hospital protocol

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Clinical Study Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Buenos Aires, , Argentina

Sanofi-Aventis Administrative Office

São Paulo, , Brazil

Sanofi-Aventis Administrative Office

Laval, , Canada

Sanofi-Aventis Administrative Office

Col. Coyoacan, , Mexico

Countries

United States; Argentina; Brazil; Canada; Mexico

Other Identifiers

LANTU_L_01687

Identifier Type: -

Identifier Source: org_study_id