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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00670228
Recruitment Status : Terminated (Due to Negative feasibility assessment of recruiting the planned number of subjects within the study timelines)
First Posted : May 1, 2008
Results First Posted : February 11, 2011
Last Update Posted : February 11, 2011
Information provided by:

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).

Condition or disease Intervention/treatment Phase
AMI Drug: Insulin Glargine (LANTUS) Drug: Insulin Glulisine (Apidra) Drug: Standard Therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Phase 3b, Stratified, Randomized, Open-label Clinical Trial to Evaluate the Efficacy of Intensive Apidra®/Lantus® Therapy vs Sliding Scale Insulin on Infarct Size in Hyperglycemic Subjects With Anterior STEMI (ST Elevation Myocardial Infarction) Undergoing PCI (Percutaneous Coronary Intervention)
Study Start Date : April 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Active Comparator: 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.
Drug: 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

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.

Active Comparator: Standard Glycemic Care (SGC)
In SGC arm subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
Drug: Standard Therapy
Standard insulin therapy titrated to blood sugar control
Other Name: multiple insulins per hospital protocol

Primary Outcome Measures :
  1. Infarct Size Absolute Change From Baseline at Day 60 [ Time Frame: From baseline at Day 60 ]
    Infarct size is measured by cardiac Magnetic Resonance Imaging (MRI) as the percentage of Left Ventricular (LV) mass.

Secondary Outcome Measures :
  1. Left Ventricular (LV) Function Evaluated by Cardiac Magnetic Resonance Imaging (MRI) [ Time Frame: At Day 3 ]
    Due to study early termination and the limited number of randomized subjects, descriptive statistics for the Day 3 Ejection Fraction were selected for presentation instead of for Day 60 as initially planned.

  2. Occurrence of the Major Adverse Cardiovascular Events (MACE) [ Time Frame: At Day 60 ]


    Cardiac death, New onset or worsening congestive heart failure (>24 h post-admission) event evaluating using New York Heart Association (NYHA) Class II or greater Non-fatal Myocardial Infarction, Severe arrhythmia, Stroke/TIA (Transient Ischemic Attack), Cardiogenic shock, Catheterization/revascularization, Unstable angina leading to hospitalisation

  3. Biomarkers of Inflammation Measurement: CRP (C-Reactive Protein) [ Time Frame: At Day 60 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670228

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Sponsors and Collaborators
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Study Director: Clinical Study Operations Sanofi
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Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00670228    
Other Study ID Numbers: LANTU_L_01687
First Posted: May 1, 2008    Key Record Dates
Results First Posted: February 11, 2011
Last Update Posted: February 11, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Insulin, Globin Zinc
Insulin Glargine
Insulin glulisine
Hypoglycemic Agents
Physiological Effects of Drugs