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

This study has been terminated.
(Due to Negative feasibility assessment of recruiting the planned number of subjects within the study timelines)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00670228
First received: April 29, 2008
Last updated: January 14, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
AMI
Drug: Insulin Glargine (LANTUS)
Drug: Insulin Glulisine (Apidra)
Drug: Standard Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Infarct Size Absolute Change From Baseline at Day 60 [ Time Frame: From baseline at Day 60 ] [ Designated as safety issue: No ]
    Infarct size is measured by cardiac Magnetic Resonance Imaging (MRI) as the percentage of Left Ventricular (LV) mass.


Secondary Outcome Measures:
  • Left Ventricular (LV) Function Evaluated by Cardiac Magnetic Resonance Imaging (MRI) [ Time Frame: At Day 3 ] [ Designated as safety issue: No ]
    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.

  • Occurrence of the Major Adverse Cardiovascular Events (MACE) [ Time Frame: At Day 60 ] [ Designated as safety issue: Yes ]

    MACE:

    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


  • Biomarkers of Inflammation Measurement: CRP (C-Reactive Protein) [ Time Frame: At Day 60 ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: April 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670228

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Mexico
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Study Operations Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00670228     History of Changes
Other Study ID Numbers: LANTU_L_01687
Study First Received: April 29, 2008
Results First Received: November 16, 2010
Last Updated: January 14, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Insulin, Globin Zinc
Glargine
Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014