NCT02607943

Brief Summary

Hyperglycemia is common during acute ischemic stroke. However, the optimal strategy to control hyperglycemia during acute ischemic stroke has not been established. The object of this multicenter randomized controlled study is to determine the efficacy and safety of early initiation of subcutaneous once-daily insulin glargine, in comparison with regular insulin, based on a protocolized sliding scale regimen to achieve proper sugar control in acute stroke patients with hyperglycemia admitted to the intensive care unit.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2015

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

2.6 years

First QC Date

November 4, 2015

Last Update Submit

August 17, 2016

Conditions

Acute StrokeHyperglycemia

Keywords

acute strokehyperglycemiaregular insulinlong-acting insulin

Outcome Measures

Primary Outcomes (1)

  • The percentage of time in the range of 80-180 mg/dL during the sugar monitoring period

    72 hours after recruitment

Secondary Outcomes (5)

  • Good functional outcome at 3 months post stroke

    3 months after stroke

  • Stroke in evolution

    one week after stroke onset

  • Blood glucose variability via continuous glucose monitoring

    72 hours after recruitment

  • Blood biomarkers

    72 hours after recruitment

  • Urine biomarkers

    72 hours after recruitment

Study Arms (2)

Insulin Glargine

EXPERIMENTAL

subcutaneous long acting basal insulin (insulin glargine) with added short acting regular insulin to correct hyperglycemic events

Drug: Insulin Glargine

Regular Insulin

ACTIVE COMPARATOR

short acting regular insulin pre-meal with added NPH at bed time if start eating

Drug: Regular Insulin

Interventions

Insulin GlargineDRUG

Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control

Also known as: Lantus
Insulin Glargine
Regular InsulinDRUG

Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control

Regular Insulin

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who admitted to stroke ICU within 24 hours of acute stroke onset and have repeated random blood glucose \>200 mg/dL with a 2 hours interval

You may not qualify if:

  • Patients with age \<20 years,
  • pregnancy,
  • shock, severe infection, end stage renal disease requiring dialysis,
  • type I DM or current steroid usage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

  • Tang SC, Shih SR, Lin SY, Chen CH, Yeh SJ, Tsai LK, Yang WS, Jeng JS. A randomized trial to investigate the efficacy and safety of insulin glargine in hyperglycemic acute stroke patients receiving intensive care. Sci Rep. 2021 Jun 1;11(1):11523. doi: 10.1038/s41598-021-91036-2.

    PMID: 34075142DERIVED

MeSH Terms

Conditions

StrokeHyperglycemiaInsulin Resistance

Interventions

Insulin GlargineInsulin

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProinsulin

Study Officials

  • Jiann-Shing Jeng, MD. PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung-Chun Tang, MD. PhD

CONTACT

886-2-23563279tangneuro@gmail.com

Jiann-Shing Jeng, MD. PhD

CONTACT

886-2-23565338jsjeng@ntu.edu.tw

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 18, 2015

Study Start

December 1, 2015

Primary Completion

July 1, 2018

Study Completion

November 1, 2018

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

TW(1)