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Efficacy and Safety of Continuous Intravenous Versus Usual Subcutaneous Insulin in Acute Ischemic Stroke

Assessment of Continuous Intravenous Insulin Protocol Versus Subcutaneous Insulin in Acute Ischemic Stroke

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00472381
Acronym
INSULINFARCT
Enrollment
180
Registered
2007-05-11
Start date
2007-05-31
Completion date
2012-06-30
Last updated
2014-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cerebral Ischemia, Acute Stroke

Keywords

Acute Ischemic Stroke, Post-Stroke Hyperglycaemia, Insulin treatment, Insulin, DWI, MRI

Brief 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.

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.

Interventions

DRUGInsulin

Insulin

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Pre-existing Modified Rankin Scale of three or higher * Advanced or terminal illness with risk of death in the next 6 months, addiction

Design outcomes

Primary

MeasureTime frame
Percentage of patients in the glucose target range within 24 hours of the initiation of treatment.24 hours

Secondary

MeasureTime frame
Modified Rankin Scale at three monthsthree months
Magnetic resonance imaging (MRI) infarct growth at one dayone day
Percentage of patients with hypoglycaemic event (< 3 mmol/l)during the study

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026