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

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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
Sponsor:
Information provided by:
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition AMI
Interventions Drug: Insulin Glargine (LANTUS)
Drug: Insulin Glulisine (Apidra)
Drug: Standard Therapy
Enrollment 34
Recruitment Details Multicenter study: 60 out of the 90 centers planned were initiated. Only 17 centers randomized patients (i.e. 7 sites in the United States, 5 sites in Argentina, 3 sites in Brazil and 2 sites in Mexico).
Pre-assignment Details Although 34 patients signed the informed consent form for study inclusion, one patient did not sign the Health Insurance Portability and Accountability Act (HIPAA) form, electing to keep his/her medical information private, and was therefore not randomized.
Arm/Group Title Intensive Insulin Therapy (IIT) Standard Glycemic Care (SGC)
Hide Arm/Group Description 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 In SGC arm Subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
Period Title: Overall Study
Started 18 15
Completed 13 12
Not Completed 5 3
Reason Not Completed
Adverse Event             1             0
Death or MACE             0             1
Not treated             2             2
Not meeting the selection criteria             2             0
Arm/Group Title Intensive Insulin Therapy (IIT) Standard Glycemic Care (SGC) Total
Hide Arm/Group Description 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 In SGC arm Subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale. Total of all reporting groups
Overall Number of Baseline Participants 18 15 33
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 15 participants 33 participants
61.11  (10.95) 62.80  (11.12) 61.88  (10.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 15 participants 33 participants
Female
6
  33.3%
2
  13.3%
8
  24.2%
Male
12
  66.7%
13
  86.7%
25
  75.8%
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 18 participants 15 participants 33 participants
26.95  (3.34) 28.49  (3.92) 27.65  (3.64)
[1]
Measure Description: BMI = body weight in kilograms/height in meters squared
Diabetes diagnosis at study entry  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 15 participants 33 participants
Yes 6 7 13
No 12 8 20
Duration of Diabetes at study entry   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 15 participants 33 participants
9.50  (9.20) 7.50  (6.80) 8.50  (7.79)
[1]
Measure Description: One data is missing for the Standard Glycemic Care (SGC) arm (n=14 subjects).
Mean time to Percutaneous Coronary Intervention (PCI)  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 18 participants 15 participants 33 participants
110.00  (112.69) 101.54  (51.47) 106.07  (88.21)
Myocardial Infarction (MI) duration greater than 3 hours  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 15 participants 33 participants
No 13 9 22
Yes 5 6 11
1.Primary Outcome
Title Infarct Size Absolute Change From Baseline at Day 60
Hide Description Infarct size is measured by cardiac Magnetic Resonance Imaging (MRI) as the percentage of Left Ventricular (LV) mass.
Time Frame From baseline at Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.
Arm/Group Title Intensive Insulin Therapy (IIT) Standard Glycemic Care (SGC)
Hide Arm/Group Description:
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
In SGC arm Subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: percentage of LV mass change
-7.84  (9.19) -15.72  (22.41)
2.Secondary Outcome
Title Left Ventricular (LV) Function Evaluated by Cardiac Magnetic Resonance Imaging (MRI)
Hide Description 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.
Time Frame At Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.
Arm/Group Title Intensive Insulin Therapy (IIT) Standard Glycemic Care (SGC)
Hide Arm/Group Description:
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
In SGC arm Subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: percentage of Ejection Fraction
43.08  (11.34) 43.43  (6.87)
3.Secondary Outcome
Title Occurrence of the Major Adverse Cardiovascular Events (MACE)
Hide Description

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

Time Frame At Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the safety population which includes all subjects who received any study treatment. All subjects in this population were analyzed according to the actual treatment they received.
Arm/Group Title Intensive Insulin Therapy (IIT) Standard Glycemic Care (SGC)
Hide Arm/Group Description:
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
In SGC arm Subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
Overall Number of Participants Analyzed 16 13
Measure Type: Number
Unit of Measure: events
Severe arrhythmia 7 2
Shock 0 1
Revascularization 1 0
New onset or worsening of congestive heart failure 1 0
Myocardial Infarction (MI) 1 0
Death 1 1
4.Secondary Outcome
Title Biomarkers of Inflammation Measurement: CRP (C-Reactive Protein)
Hide Description [Not Specified]
Time Frame At Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Modified Intention To Treat (MITT) population which includes all randomized subjects who took at least one dose of the study medication, undergone PCI procedure at hospital admission, and had a valid post-PCI infarct size.
Arm/Group Title Intensive Insulin Therapy (IIT) Standard Glycemic Care (SGC)
Hide Arm/Group Description:
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
In SGC arm Subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: mg/L
2.52  (2.10) 2.96  (4.07)
Time Frame Adverse events are collected from the first to the last drug intake + 1 week after the administration of the last intake i.e. end of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intensive Insulin Therapy (IIT) Standard Glycemic Care (SGC)
Hide Arm/Group Description 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 In SGC arm Subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale.
All-Cause Mortality
Intensive Insulin Therapy (IIT) Standard Glycemic Care (SGC)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intensive Insulin Therapy (IIT) Standard Glycemic Care (SGC)
Affected / at Risk (%) Affected / at Risk (%)
Total   6/16 (37.50%)   3/13 (23.08%) 
Cardiac disorders     
Bradycardia  1  2/16 (12.50%)  0/13 (0.00%) 
Cardiac Failure Congestive  1  0/16 (0.00%)  1/13 (7.69%) 
Cardiogenic Shock  1  1/16 (6.25%)  1/13 (7.69%) 
Pericardial Effusion  1  1/16 (6.25%)  0/13 (0.00%) 
Pericarditis  1  1/16 (6.25%)  0/13 (0.00%) 
Sinus Tachycardia  1  1/16 (6.25%)  0/13 (0.00%) 
Ventricular Tachycardia  1  0/16 (0.00%)  2/13 (15.38%) 
Infections and infestations     
Bronchopneumonia  1  1/16 (6.25%)  0/13 (0.00%) 
Pneumonia  1  1/16 (6.25%)  0/13 (0.00%) 
Psychiatric disorders     
Psychotic Disorder  1  1/16 (6.25%)  0/13 (0.00%) 
Renal and urinary disorders     
Renal Failure Acute  1  1/16 (6.25%)  0/13 (0.00%) 
Vascular disorders     
Hypotension  1  2/16 (12.50%)  0/13 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intensive Insulin Therapy (IIT) Standard Glycemic Care (SGC)
Affected / at Risk (%) Affected / at Risk (%)
Total   10/16 (62.50%)   6/13 (46.15%) 
Blood and lymphatic system disorders     
Anaemia  1  1/16 (6.25%)  0/13 (0.00%) 
Haemorrhagic Anaemia  1  1/16 (6.25%)  0/13 (0.00%) 
Leukocytosis  1  1/16 (6.25%)  0/13 (0.00%) 
Cardiac disorders     
Angina Pectoris  1  1/16 (6.25%)  0/13 (0.00%) 
Atrial Fibrillation  1  1/16 (6.25%)  0/13 (0.00%) 
Cardiac Failure Congestive  1  1/16 (6.25%)  0/13 (0.00%) 
Myocardial Infarction  1  2/16 (12.50%)  0/13 (0.00%) 
Myocardial Ischaemia  1  1/16 (6.25%)  0/13 (0.00%) 
Supraventricular Tachycardia  1  1/16 (6.25%)  0/13 (0.00%) 
Ventricular Extrasystoles  1  0/16 (0.00%)  2/13 (15.38%) 
Ventricular Fibrillation  1  1/16 (6.25%)  0/13 (0.00%) 
Ventricular Tachycardia  1  1/16 (6.25%)  0/13 (0.00%) 
Gastrointestinal disorders     
Constipation  1  2/16 (12.50%)  0/13 (0.00%) 
Diarrhoea  1  1/16 (6.25%)  0/13 (0.00%) 
Dyspepsia  1  1/16 (6.25%)  0/13 (0.00%) 
Intestinal Ischaemia  1  1/16 (6.25%)  0/13 (0.00%) 
Nausea  1  1/16 (6.25%)  2/13 (15.38%) 
Vomiting  1  1/16 (6.25%)  2/13 (15.38%) 
General disorders     
Fatigue  1  1/16 (6.25%)  0/13 (0.00%) 
Injection Site Phlebitis  1  1/16 (6.25%)  0/13 (0.00%) 
Pyrexia  1  1/16 (6.25%)  1/13 (7.69%) 
Sudden Cardiac Death  1  0/16 (0.00%)  1/13 (7.69%) 
Venipuncture Site Swelling  1  1/16 (6.25%)  0/13 (0.00%) 
Vessel Puncture Site Haematoma  1  2/16 (12.50%)  1/13 (7.69%) 
Vessel Site Puncture Haemorrhage  1  1/16 (6.25%)  0/13 (0.00%) 
Vessel Puncture Site Pain  1  0/16 (0.00%)  1/13 (7.69%) 
Infections and infestations     
Urinary Tract Infection  1  1/16 (6.25%)  0/13 (0.00%) 
Investigations     
Blood Magnesium Decreased  1  1/16 (6.25%)  0/13 (0.00%) 
Transaminases Increased  1  1/16 (6.25%)  0/13 (0.00%) 
Metabolism and nutrition disorders     
Hyperkalaemia  1  1/16 (6.25%)  0/13 (0.00%) 
Hypocalcaemia  1  1/16 (6.25%)  0/13 (0.00%) 
Hypokalaemia  1  2/16 (12.50%)  0/13 (0.00%) 
Hypomagnesaemia  1  1/16 (6.25%)  1/13 (7.69%) 
Hyponatraemia  1  1/16 (6.25%)  1/13 (7.69%) 
Metabolic Acidosis  1  1/16 (6.25%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  2/16 (12.50%)  1/13 (7.69%) 
Flank Pain  1  1/16 (6.25%)  0/13 (0.00%) 
Musculoskeletal Pain  1  0/16 (0.00%)  1/13 (7.69%) 
Nervous system disorders     
Dizziness  1  1/16 (6.25%)  0/13 (0.00%) 
Headache  1  2/16 (12.50%)  1/13 (7.69%) 
Psychiatric disorders     
Agitation  1  1/16 (6.25%)  0/13 (0.00%) 
Anxiety  1  0/16 (0.00%)  1/13 (7.69%) 
Confusional State  1  2/16 (12.50%)  0/13 (0.00%) 
Insomnia  1  0/16 (0.00%)  1/13 (7.69%) 
Renal and urinary disorders     
Haematuria  1  2/16 (12.50%)  0/13 (0.00%) 
Renal Failure  1  1/16 (6.25%)  0/13 (0.00%) 
Urinary Retention  1  0/16 (0.00%)  1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary Congestion  1  1/16 (6.25%)  0/13 (0.00%) 
Upper Respiratory Tract Congestion  1  0/16 (0.00%)  1/13 (7.69%) 
Wheezing  1  1/16 (6.25%)  0/13 (0.00%) 
Skin and subcutaneous tissue disorders     
Petechia  1  1/16 (6.25%)  0/13 (0.00%) 
Pruritus  1  1/16 (6.25%)  0/13 (0.00%) 
Vascular disorders     
Hypotension  1  4/16 (25.00%)  0/13 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Early termination leading to small numbers of subjects analyzed. Only descriptive statistics were presented for primary and key secondary efficacy endpoints. The analysis focused on a review of safety Adverse Events (AEs) data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: sanofi-aventis
EMail: GV-contact-us@sanofi-aventis.com
Layout table for additonal information
Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00670228     History of Changes
Other Study ID Numbers: LANTU_L_01687
First Submitted: April 29, 2008
First Posted: May 1, 2008
Results First Submitted: November 16, 2010
Results First Posted: February 11, 2011
Last Update Posted: February 11, 2011