Acute StrokePhase 2/3INSULINFARCTNCT00472381
Efficacy and Safety of Continuous Intravenous Versus Usual Subcutaneous Insulin in Acute Ischemic Stroke
A Phase 2/3 study testing Insulin in people with Acute Stroke and Acute Cerebral Ischemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Hyperglycaemia is a frequent finding in acute ischemic stroke and associated with poor outcome. But the modalities of glucose lowering are still debated. This study will test the efficacy and safety of continuous intravenous insulin protocol versus usual subcutaneous insulin in acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Stroke, Acute Cerebral Ischemia
- What is being tested?
- Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- May 2007to Jun 2012
- Phase
- Phase 2/3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Carotid territory stroke
- MRI performed in the first five hours of stroke onset
- Baseline National Institutes of Health Stroke Scale (NIHSS) > 4 or < 26
- Time between MRI and treatment under one hour
Who cannot join
- Pre-existing Modified Rankin Scale of three or higher
- Advanced or terminal illness with risk of death in the next 6 months, addiction
Trial locations and contacts
1 site in 1 country.
France1 site
AP-HP Urgences cerebro vasculaires La Pitié Salpétrière
Poissy, 75013
About this study
Official title: Assessment of Continuous Intravenous Insulin Protocol Versus Subcutaneous Insulin in Acute Ischemic Stroke
Hyperglycaemia is a frequent finding in acute ischemic stroke and associated with poor outcome. But the modalities of glucose lowering are still debated. This study will test the efficacy and safety of continuous intravenous insulin protocol versus usual subcutaneous insulin in acute ischemic stroke.
Read the detailed description
It is demonstrated that post-stroke hyperglycaemia is associated with poor outcome. Yet, the efficiency of aggressive insulin serum glucose control is not established. Furthermore the modalities of insulin administration are discussed since US and European guidelines recommend subcutaneous administration, whereas some groups use intravenous administration of insulin. The purpose of this study is to compare the efficacy and the safety of a continuous intravenous insulin protocol versus classical subcutaneous administration of insulin. The study will include carotid territory stroke at the acute stage (< 6 hours of onset) confirmed by MRI, and randomized in intravenous versus subcutaneous insulin. The percentage of patients in the target range (mean capillary glycaemia within 24 hours < 7 mmol/l) is the primary outcome. The secondary outcomes include comparison of Modified Rankin Scale at 3 months, rate of hypoglycaemic events and comparison of Infarct Growth as measured on MRI.
- Conditions
- Acute Stroke, Acute Cerebral Ischemia
- Being tested
- Insulin
- Keywords
- Acute Ischemic Stroke, Post-Stroke Hyperglycaemia, Insulin treatment, Insulin, DWI, MRI
- Medical subject headings
- Stroke, Ischemic Stroke, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Insulin
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Insulin Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients in the glucose target range within 24 hours of the initiation of treatment.
Measured: 24 hours
Secondary outcomes (3)
Modified Rankin Scale at three months
Measured: three months
Magnetic resonance imaging (MRI) infarct growth at one day
Measured: one day
Percentage of patients with hypoglycaemic event (< 3 mmol/l)
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Samson, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472381
- Sponsor's protocol ID
- P060202
- Acronym
- INSULINFARCT
- Status last verified
- Sep 2012
- First submitted
- 10 May 2007
- Last updated
- 5 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Samson Y, Bruandet M, Lejeune M, Deltour S, Grimaldi A. [Insulin in the treatment of ischemic stroke]. Presse Med. 2006 Apr;35(4 Pt 2):696-8. doi: 10.1016/s0755-4982(06)74664-4. French.
PubMed 16614616Rosso C, Pires C, Corvol JC, Baronnet F, Crozier S, Leger A, Deltour S, Valabregue R, Amor-Sahli M, Lehericy S, Dormont D, Samson Y. Hyperglycaemia, insulin therapy and critical penumbral regions for prognosis in acute stroke: further insights from the INSULINFARCT trial. PLoS One. 2015 Mar 20;10(3):e0120230. doi: 10.1371/journal.pone.0120230. eCollection 2015.
PubMed 25793765Rosso C, Corvol JC, Pires C, Crozier S, Attal Y, Jacqueminet S, Deltour S, Multlu G, Leger A, Meresse I, Payan C, Dormont D, Samson Y. Intensive versus subcutaneous insulin in patients with hyperacute stroke: results from the randomized INSULINFARCT trial. Stroke. 2012 Sep;43(9):2343-9. doi: 10.1161/STROKEAHA.112.657122. Epub 2012 Jun 14.
PubMed 22700528
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Continuous Intravenous Insulin Protocol Versus Subcutaneous Insulin in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00472381
- Acronym / sponsor ID
- INSULINFARCT / P060202
- Conditions
- Acute Stroke, Acute Cerebral Ischemia
- Keywords
- Acute Ischemic Stroke, Post-Stroke Hyperglycaemia, Insulin treatment, Insulin, DWI, MRI
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 May 2007 (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.
Hyperglycaemia is a frequent finding in acute ischemic stroke and associated with poor outcome. But the modalities of glucose lowering are still debated. This study will test the efficacy and safety of continuous intravenous insulin protocol versus usual subcutaneous insulin in acute ischemic stroke.
Detailed description
It is demonstrated that post-stroke hyperglycaemia is associated with poor outcome. Yet, the efficiency of aggressive insulin serum glucose control is not established. Furthermore the modalities of insulin administration are discussed since US and European guidelines recommend subcutaneous administration, whereas some groups use intravenous administration of insulin. The purpose of this study is to compare the efficacy and the safety of a continuous intravenous insulin protocol versus classical subcutaneous administration of insulin. The study will include carotid territory stroke at the acute stage (< 6 hours of onset) confirmed by MRI, and randomized in intravenous versus subcutaneous insulin. The percentage of patients in the target range (mean capillary glycaemia within 24 hours < 7 mmol/l) is the primary outcome. The secondary outcomes include comparison of Modified Rankin Scale at 3 months, rate of hypoglycaemic events and comparison of Infarct Growth as measured on MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: InsulinInsulin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 18 years
- Carotid territory stroke
- MRI performed in the first five hours of stroke onset
- Baseline National Institutes of Health Stroke Scale (NIHSS) > 4 or < 26
- Time between MRI and treatment under one hour
Key exclusion criteria (2 listed)
- Pre-existing Modified Rankin Scale of three or higher
- Advanced or terminal illness with risk of death in the next 6 months, addiction
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 |
|---|---|---|
| InsulinInsulin | Drug | 2 |
Primary outcome
Percentage of patients in the glucose target range within 24 hours of the initiation of treatment.
Time frame: 24 hours
3 secondary outcomes
Modified Rankin Scale at three months
Time frame: three months
Magnetic resonance imaging (MRI) infarct growth at one day
Time frame: one day
Percentage of patients with hypoglycaemic event (< 3 mmol/l)
Time frame: during the study
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 5 Jun 2014.
- Results publication: PubMed 16614616Samson Y, Bruandet M, Lejeune M, Deltour S, Grimaldi A. [Insulin in the treatment of ischemic stroke]. Presse Med. 2006 Apr;35(4 Pt 2):696-8. doi: 10.1016/s0755-4982(06)74664-4. French.
- Derived from this study: PubMed 25793765Rosso C, Pires C, Corvol JC, Baronnet F, Crozier S, Leger A, Deltour S, Valabregue R, Amor-Sahli M, Lehericy S, Dormont D, Samson Y. Hyperglycaemia, insulin therapy and critical penumbral regions for prognosis in acute stroke: further insights from the INSULINFARCT trial. PLoS One. 2015 Mar 20;10(3):e0120230. doi: 10.1371/journal.pone.0120230. eCollection 2015.
- Derived from this study: PubMed 22700528Rosso C, Corvol JC, Pires C, Crozier S, Attal Y, Jacqueminet S, Deltour S, Multlu G, Leger A, Meresse I, Payan C, Dormont D, Samson Y. Intensive versus subcutaneous insulin in patients with hyperacute stroke: results from the randomized INSULINFARCT trial. Stroke. 2012 Sep;43(9):2343-9. doi: 10.1161/STROKEAHA.112.657122. Epub 2012 Jun 14.
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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.
Yves Samson, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Insulin in people with Acute Stroke and Acute Cerebral Ischemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 2 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 5 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of patients in the glucose target range within 24 hours of the initiation of treatment. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00472381, which also lists 3 linked publications.
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 5 Jun 2014.