DiabetesPhase 4INSUCORNCT00362778
Intensive Insulin Therapy in Non-diabetic Patients With Acute Myocardial Infarction and Hyperglycaemia
A Phase 4 study testing Insulin in people with Diabetes and Hyperglycemia, run by Hospital Clinic of Barcelona.
Trial summary
Hyperglycemia at admission has been associated with bad prognosis in patients with acute myocardial infarction (AMI). The clinical benefit of intensive treatment with insulin has been evaluated in diabetic patients admitted to intensive care units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Hyperglycemia, Acute Myocardial Infarction
- What is being tested?
- Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jun 2007
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of AMI, either with or without ST segment elevation
- Presence of high blood glucose at admission with no previously known diabetes mellitus (DM)
Who cannot join
- Age under 18 years old
- History of DM
- Presence of other cardiopathies (dilated cardiomyopathy, valvular or hypertrophic heart disease)
- Unstable AMI patients (haemodynamic instability or arrhythmic disorders)
- Platelet aggregation or coagulation disorders
- Severe conditions with an estimated short (under 1 year) life expectancy
- Participation in other trials
- Patient refusal to participate in the study
About this study
Hyperglycemia at admission has been associated with bad prognosis in patients with acute myocardial infarction (AMI). The clinical benefit of intensive treatment with insulin has been evaluated in diabetic patients admitted to intensive care units. The aim of our study was to assess the short-term effects and the safety of strict glycemic control in subjects with AMI and hyperglycemia without a previous history of diabetes.
Read the detailed description
Twenty-eight non-previously diabetic patients admitted with AMI and hyperglycemia were randomized to two treatment arms, administered during the first 48 hours: the intensive group (n=13) received intravenous insulin with target glycemia levels of 80-110mg/dL, while the conventional group (n=15) received subcutaneous insulin only when glycemia was ³ 160mg/dL. High-sensitivity C-reactive protein (HS-CRP) was determined at 48 hours and before discharge and an oral glucose tolerance test (OGTT) was performed at 1 month.
- Conditions
- Diabetes, Hyperglycemia, Acute Myocardial Infarction
- Being tested
- Insulin
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
intravenous continuous insulin infusion for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Serum saline | Sham comparator | Not described Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Measured: first 48 hours
Secondary outcomes (1)
High-sensitivity C-reactive protein levels
Measured: At 48 hours and aat hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Bosch, Hospital Clinic of Barcelona
- Investigators
- Xavier Bosch, Principal investigator, Cardiology Department. Hospital Clínic i Universitari Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362778
- Sponsor's protocol ID
- The INSUCOR study
- Acronym
- INSUCOR
- Status last verified
- Mar 2012
- First submitted
- 8 Aug 2006
- Last updated
- 20 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Insulin Therapy in Non-diabetic Patients With Acute Myocardial Infarction and Hyperglycaemia
- ClinicalTrials.gov ID
- NCT00362778
- Acronym / sponsor ID
- INSUCOR / The INSUCOR study
- Conditions
- Diabetes, Hyperglycemia, Acute Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 10 Aug 2006 (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.
Hyperglycemia at admission has been associated with bad prognosis in patients with acute myocardial infarction (AMI). The clinical benefit of intensive treatment with insulin has been evaluated in diabetic patients admitted to intensive care units. The aim of our study was to assess the short-term effects and the safety of strict glycemic control in subjects with AMI and hyperglycemia without a previous history of diabetes.
Detailed description
Twenty-eight non-previously diabetic patients admitted with AMI and hyperglycemia were randomized to two treatment arms, administered during the first 48 hours: the intensive group (n=13) received intravenous insulin with target glycemia levels of 80-110mg/dL, while the conventional group (n=15) received subcutaneous insulin only when glycemia was ³ 160mg/dL. High-sensitivity C-reactive protein (HS-CRP) was determined at 48 hours and before discharge and an oral glucose tolerance test (OGTT) was performed at 1 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serum saline | Sham comparator | Drug: Insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of AMI, either with or without ST segment elevation
- Presence of high blood glucose at admission with no previously known diabetes mellitus (DM)
Key exclusion criteria (8 listed)
- Age under 18 years old
- History of DM
- Presence of other cardiopathies (dilated cardiomyopathy, valvular or hypertrophic heart disease)
- Unstable AMI patients (haemodynamic instability or arrhythmic disorders)
- Platelet aggregation or coagulation disorders
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 |
|---|---|---|
| Insulinintravenous continuous insulin infusion for 48 hours | Drug | Serum saline |
Primary outcome
Glycemic control
Time frame: first 48 hours
1 secondary outcome
High-sensitivity C-reactive protein levels
Time frame: At 48 hours and aat hospital 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 20 Mar 2012.
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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.
Xavier Bosch principal investigator
Cardiology Department. Hospital Clínic i Universitari Barcelona
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin in people with Diabetes and Hyperglycemia, run by Hospital Clinic of Barcelona.
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 2 inclusion and 8 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 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Glycemic control (time frame: first 48 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 20 Mar 2012.