HyperglycemiaPhase 3RECREATE PilotNCT00640991
REsearching Coronary REduction by Appropriately Targeting Euglycemia (RECREATE Pilot Study)
A Phase 3 study testing glulisine insulin, glargine insulin in people with Hyperglycemia and Cardiovascular Diseases, run by Population Health Research Institute at 13 sites in 3 countries.
Trial summary
Insulin will safely reduce glucose levels in patients with acute ST-elevation myocardial infarction and admission hyperglycemia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperglycemia, Cardiovascular Diseases, Myocardial Infarction
- What is being tested?
- glulisine insulin, glargine insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Apr 2008to Jun 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Both nondiabetic patients and patients with non-insulin-requiring type 2 diabetes mellitus admitted with a suspected AMI are eligible if they meet the following criteria:
- Signs or symptoms of AMI with definite ECG changes, defined as persistent ST-segment elevation (> or = than 1 mm)in two or more contiguous leads, or new left bundle branch block
- Onset of symptoms within 24 hours before hospital presentation
- Capillary blood glucose level on presentation > or = 8.0 mmol/L (144 mg/dL)
Who cannot join
- Patient with conditions that REQUIRE the administration of insulin, including:
- Type 1 diabetes mellitus, defined by a documented history of diabetes mellitus before the age of 30
- Type 2 diabetes mellitus that was treated with insulin prior to AMI presentation
- Type 2 diabetes mellitus that is known to be very poorly controlled (e.g. admission capillary blood glucose > 16.0 mmol/L (288 mg/dL)or marked elevation in glucose for which the site investigator plans to treat with insulin therapy)
- A history of severe hypoglycemic episodes (defined as hypoglycemia with symptoms which the patient is unable to reverse without the assistance of another person) within the past two years
- Known or suspected end-stage liver disease (due to the risk of hypoglycemia in the setting of liver dysfunction and consequent impaired regulation of glucose homeostasis)
Show all 11Show fewer
- Cardiogenic shock on admission (due to the inaccuracy of glucose meter readings)
- Documented pregnancy
- Any concomitant disease (e.g. cancer) that might limit life expectancy to less than 90 days
- Anticipated poor adherence with study treatments or an other factor that might jeopardize 90-day follow-up (e.g. no fixed address, long distance to hospital, etc.)
- Prior enrollment in this trial or current enrollment in another trial of ST-segment elevation myocardial infarction
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
India11 sites
St. Johns Medical College
Bangalore, Karnataka, 560034
Baby Memorial Hospital
Calicut, Kerala, 673004
Railway Hospital
Chennai, Tamil Nadu, 600023
Assam Medical College Hospital
Dt. Dibrugarh, Assam, 786002
Caritas Hospital
Kottayam, Kerala, 686016
KEM Hospital
Mumbai, Maharashtra, 400012
Avanti Institute of Cardiology
Nagpur, 440012
Lifeworth Super Specialty Hospital
Raipur, Chhattisgarh, 492001
Post Graduate Institute of Medical
Rohtak, Haryana, 124001
Nanjappa Hospital
Shimoga, Karnataka, 577201
MGIMS
Wardha, Maharashtra, 442102
About this study
Official title: An International Multicentre Randomized Controlled Trial of Intensive Insulin Therapy Targeting Normoglycemia In Acute Myocardial Infarction: the RECREATE (REsearching Coronary REduction by Appropriately Targeting Euglycemia) Pilot Study
Insulin will safely reduce glucose levels in patients with acute ST-elevation myocardial infarction and admission hyperglycemia.
Read the detailed description
Patients will be randomly assigned to either the control arm and will receive usual AMI care or the experimental arm, which will include routine AMI care as well as intensive therapy intervention.
In addition to the capillary blood glucose measurements obtained to titrate insulin doses in the experimental arm patients, laboratory plasma glucose will be drawn in all patients at randomization, 10, 24, 48, and 72 hours post randomization, 7 days post randomization (or hospital discharge if that occurs first), and 30 days post randomization.
- Being tested
- glulisine insulin, glargine insulin
- Keywords
- Clinical Trial, Insulin
- Medical subject headings
- Hyperglycemia, Cardiovascular Diseases, Myocardial Infarction, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glulisine insulin, glargine insulinDrug
Also called Apidra, Lantus
IV infusion of glulisine, SC injection of glargine
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients assigned to the control arm will receive usual care for AMI, according to local practice of each participating centre. |
| Intervention | Experimental | The experimental arm will have an IV infusion of glulisine insulin started directly after randomization for at least 24 hours and for as long as CCU-level care is required, and the insulin infusion will be adjusted to achieve and maintain a target glucose range of 5.0-6.6 mmol/L (90-118 mg/dL). Once transferred to the ward, patients in the experimental arm will switch to glargine insulin and will continue this treatment for the remainder of their hospitalization and after hospital discharge, for a total duration of 30 days post randomization. Receives: Drug: glulisine insulin, glargine insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 24-hour difference in mean glucose between the two study groups.
Measured: 24 hours
Secondary outcomes (11)
The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first)
Measured: 7 days or discharge
The difference in mean glucose level achieved at 30 days between study groups
Measured: 30 days
Nonfatal recurrent myocardial infarction, nonfatal stroke, or cardiovascular death (as a composite and as separate outcomes)
Measured: Discharge, 30 days, 90 days, 1 year
Rehospitalization for congestive heart failure
Measured: Discharge, 30 days, 90 days, 1 year
All cause mortality
Measured: Discharge, 30 days, 90 days, 1 year
Resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes)
Measured: Discharge, 30 days, 90 days, 1 year
Cardiogenic shock
Measured: Discharge, 30 days, 90 days, 1 year
Cardiac procedures
Measured: Discharge, 30 days, 90 days, 1 year
Rehospitalization for any cause
Measured: Discharge, 30 days, 90 days, 1 year
Symptomatic and severe hypoglycemic episodes
Measured: Discharge, 30 days, 90 days, 1 year
Hypokalemic episodes
Measured: Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Hertzel Gerstein, MD, MSc, FRCPC, Principal investigator, McMaster UniversitySalim Yusuf, DPhil, FRCPC, FRSC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640991
- Sponsor's protocol ID
- RECREATE Pilot
- Acronym
- RECREATE Pilot
- Status last verified
- Jun 2009
- First submitted
- 18 Mar 2008
- Last updated
- 16 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Multicentre Randomized Controlled Trial of Intensive Insulin Therapy Targeting Normoglycemia In Acute Myocardial Infarction: the RECREATE (REsearching Coronary REduction by Appropriately Targeting Euglycemia) Pilot Study
- ClinicalTrials.gov ID
- NCT00640991
- Acronym / sponsor ID
- RECREATE Pilot / RECREATE Pilot
- Keywords
- Clinical Trial, Insulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 21 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Insulin will safely reduce glucose levels in patients with acute ST-elevation myocardial infarction and admission hyperglycemia.
Detailed description
Patients will be randomly assigned to either the control arm and will receive usual AMI care or the experimental arm, which will include routine AMI care as well as intensive therapy intervention.
In addition to the capillary blood glucose measurements obtained to titrate insulin doses in the experimental arm patients, laboratory plasma glucose will be drawn in all patients at randomization, 10, 24, 48, and 72 hours post randomization, 7 days post randomization (or hospital discharge if that occurs first), and 30 days post randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients assigned to the control arm will receive usual care for AMI, according to local practice of each participating centre. |
| Intervention | Experimental | Drug: glulisine insulin, glargine insulinThe experimental arm will have an IV infusion of glulisine insulin started directly after randomization for at least 24 hours and for as long as CCU-level care is required, and the insulin infusion will be adjusted to achieve and maintain a target glucose range of 5.0-6.6 mmol/L (90-118 mg/dL). Once transferred to the ward, patients in the experimental arm will switch to glargine insulin and will continue this treatment for the remainder of their hospitalization and after hospital discharge, for a total duration of 30 days post randomization. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Both nondiabetic patients and patients with non-insulin-requiring type 2 diabetes mellitus admitted with a suspected AMI are eligible if they meet the following criteria:
- Signs or symptoms of AMI with definite ECG changes, defined as persistent ST-segment elevation (> or = than 1 mm)in two or more contiguous leads, or new left bundle branch block
- Onset of symptoms within 24 hours before hospital presentation
- Capillary blood glucose level on presentation > or = 8.0 mmol/L (144 mg/dL)
Key exclusion criteria (11 listed)
- Patient with conditions that REQUIRE the administration of insulin, including:
- A history of severe hypoglycemic episodes (defined as hypoglycemia with symptoms which the patient is unable to reverse without the assistance of another person) within the past two years
- Known or suspected end-stage liver disease (due to the risk of hypoglycemia in the setting of liver dysfunction and consequent impaired regulation of glucose homeostasis)
- Cardiogenic shock on admission (due to the inaccuracy of glucose meter readings)
- Documented pregnancy
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 |
|---|---|---|
| glulisine insulin, glargine insulinAlso: Apidra, LantusIV infusion of glulisine, SC injection of glargine | Drug | Intervention |
Primary outcome
The 24-hour difference in mean glucose between the two study groups.
Time frame: 24 hours
11 secondary outcomes
The difference in mean glucose level achieved at 7 days or hospital discharge (whichever is first)
Time frame: 7 days or discharge
The difference in mean glucose level achieved at 30 days between study groups
Time frame: 30 days
Nonfatal recurrent myocardial infarction, nonfatal stroke, or cardiovascular death (as a composite and as separate outcomes)
Time frame: Discharge, 30 days, 90 days, 1 year
Rehospitalization for congestive heart failure
Time frame: Discharge, 30 days, 90 days, 1 year
All cause mortality
Time frame: Discharge, 30 days, 90 days, 1 year
Resuscitated cardiac arrest or life-threatening arrhythmia (as a composite and as separate outcomes)
Time frame: Discharge, 30 days, 90 days, 1 year
Cardiogenic shock
Time frame: Discharge, 30 days, 90 days, 1 year
Cardiac procedures
Time frame: Discharge, 30 days, 90 days, 1 year
Rehospitalization for any cause
Time frame: Discharge, 30 days, 90 days, 1 year
Symptomatic and severe hypoglycemic episodes
Time frame: Discharge, 30 days, 90 days, 1 year
Hypokalemic episodes
Time frame: Discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2010.
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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.
Hertzel Gerstein, MD, MSc, FRCPC principal investigator
McMaster University
Salim Yusuf, DPhil, FRCPC, FRSC principal investigator
McMaster University
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing glulisine insulin, glargine insulin in people with Hyperglycemia and Cardiovascular Diseases, run by Population Health Research Institute at 13 sites in 3 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 16 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in India, Argentina, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The 24-hour difference in mean glucose between the two study groups. (time frame: 24 hours). 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 16 Jun 2010; AzTrials last refreshed its copy on 31 Oct 2026.