AMIPhase 3INTENSIVENCT00670228
Effect of Lantus and Apidra in Patients With Acute ST Elevation Myocardial Infarction
A Phase 3 study testing Insulin Glargine (LANTUS), Insulin Glulisine (Apidra) and Standard Therapy in people with AMI, run by Sanofi at 5 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- AMI
- What is being tested?
- Insulin Glargine (LANTUS), Insulin Glulisine (Apidra) and Standard Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Apr 2008to Nov 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey
About this study
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)
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
- Being tested
- Insulin Glargine (LANTUS), Insulin Glulisine (Apidra), Standard Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Glargine (LANTUS)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)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 TherapyDrug
Also called multiple insulins per hospital protocol
Standard insulin therapy titrated to blood sugar control
| Study group | Role | What they receive |
|---|---|---|
| Intensive Insulin Therapy (IIT) | Active comparator | 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. Receives: Drug: Insulin Glargine (LANTUS); Drug: Insulin Glulisine (Apidra) |
| Standard Glycemic Care (SGC) | Active comparator | In SGC arm subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale. Receives: Drug: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct Size Absolute Change From Baseline at Day 60
Infarct size is measured by cardiac Magnetic Resonance Imaging (MRI) as the percentage of Left Ventricular (LV) mass.
Measured: From baseline at Day 60
Secondary outcomes (3)
Left Ventricular (LV) Function Evaluated by Cardiac Magnetic Resonance Imaging (MRI)
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.
Measured: At Day 3
Occurrence of the Major Adverse Cardiovascular Events (MACE)
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
Measured: At Day 60
Biomarkers of Inflammation Measurement: CRP (C-Reactive Protein)
Measured: At Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Due to Negative feasibility assessment of recruiting the planned number of subjects within the study timelines
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AMIStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Study Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670228
- Sponsor's protocol ID
- LANTU_L_01687
- Acronym
- INTENSIVE
- Status last verified
- Jan 2011
- First submitted
- 29 Apr 2008
- Last updated
- 11 Feb 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00670228
- Acronym / sponsor ID
- INTENSIVE / LANTU_L_01687
- Conditions
- AMI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to Negative feasibility assessment of recruiting the planned number of subjects within the study timelines
- Enrolment
- 34 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 1 May 2008 (estimated)
- Results
- Posted 11 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Insulin Therapy (IIT) | Active comparator | Drug: Insulin Glargine (LANTUS), Drug: Insulin Glulisine (Apidra)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. |
| Standard Glycemic Care (SGC) | Active comparator | Drug: Standard TherapyIn SGC arm subjects assigned to "standard of care" received subcutaneous regular insulin per sliding scale. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Intensive Insulin Therapy (IIT) |
| 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. | Drug | Intensive Insulin Therapy (IIT) |
| Standard TherapyAlso: multiple insulins per hospital protocolStandard insulin therapy titrated to blood sugar control | Drug | Standard Glycemic Care (SGC) |
Primary outcome
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.
3 secondary outcomes
Left Ventricular (LV) Function Evaluated by Cardiac Magnetic Resonance Imaging (MRI)
Time frame: At Day 3
Occurrence of the Major Adverse Cardiovascular Events (MACE)
Time frame: At Day 60
Biomarkers of Inflammation Measurement: CRP (C-Reactive Protein)
Time frame: At Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Operations study director
Sanofi
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin Glargine (LANTUS), Insulin Glulisine (Apidra) and Standard Therapy in people with AMI, run by Sanofi at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Argentina, Brazil, Canada, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct Size Absolute Change From Baseline at Day 60 (time frame: From baseline at Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2011.