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Comparing the Safety and Efficacy of Insulin GLARGINE and DEGLUDEC in Glucocorticoid Induced HYPERGLYCEMIA in Hospitalized Patients".

NCT07599891 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2026-05-20

No results posted yet for this study

Summary

Glucocorticoids (GC) represent therapeutic agents of great importance in the treatment and prophylaxis of multiple inflammatory and non-inflammatory conditions. Despite their efficacy, the use of GCs is associated with a variety of side effects, one of the immediate ones being the development of glucocorticoids induced hyperglycemia.

GCs decrease peripheral insulin sensitivity, increase hepatic gluconeogenesis, trigger insulin resistance, as well as inhibit pancreatic insulin production.(\[1\] It has been shown that acute and chronic hyperglycemia that are present in many cases in the hospital setting are important risk factors for prolonged hospital stays, infectious complications, poorer surgical outcomes, and increased mortality.

In-hospital glucocorticoid induced hyperglycemia is usually managed with optimization of oral anti-diabetic drugs and basal bolus insulin, which has been well established over sliding scale insulin as the preferred regimen for GIH. Through this study we aim to compare to different basal insulins, glargine and degludec in terms of their efficacy and safety (hypoglycemic events) in this setting.

Conditions

  • Glucocorticoid Induced Hyperglycemia

Interventions

DRUG

Degludec insulin

Degludec was used as part of basal bolus insulin regimen in the experimental arm of this study. Glargine was used as active comparator.

DRUG

Glargine insulin

Glargine was used as part of basal bolus insulin regimen in the active comparator arm of this study.

Sponsors & Collaborators

  • Max Healthcare Insititute Limited

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • India

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 NCT07599891 on ClinicalTrials.gov