Early Administration of Insulin Glargine in Patients With Diabetic Ketoacidosis

NCT06007508 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-06-18

No results posted yet for this study

Summary

Diabetic ketoacidosis (DKA) is a medical emergency that is associated with significant morbidity and mortality for both patients with type I and type II diabetes. By correcting hyperglycemia and inhibiting the release of free fatty acids, insulin administration leads to decreased ketone formation and resolution of acidosis. Short-acting intravenous insulin is often preferred to subcutaneous administration for initial management due to its short half-life and ease of titration, but patients will eventually need to transition to subcutaneous insulin prior to discharge. The timing of initiation or resumption of home long-acting subcutaneous insulin is controversial in the treatment of DKA. It is currently unknown if resuming a portion or all of the patient's home basal regimen during the initial treatment phase of DKA will provide an impact on patient care. The purpose of this study is to evaluate the impact of early glargine administration if the patient was not previously on basal insulin or resuming the patient's home basal insulin regimen within two hours after the start of the intravenous insulin infusion in addition to usual care will improve patient outcomes.

Conditions

  • DKA

Interventions

DRUG

Insulin Glargine

Long-acting insulin

Sponsors & Collaborators

  • HealthPartners Institute

    lead OTHER

Principal Investigators

  • Adis Keric, PharmD · Regions Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2023-02-28
Completion
2023-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06007508 on ClinicalTrials.gov