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

NCT07599891 | Completed Phase 4 DMC

• 1 other identifier: :MIME/DNB/SKT-2023-0987
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (8)

• basal insulin dose - on Day 1 and Day 5 of basal bolus treatment

  Basal insulin dose measured in units on Day 1 and Day 5 of basal bolus treatment - expressed in IU

  for 5 days while admitted to the hospital, from Day 1 of initiation of basal bolus insulin in hospital, to Day 5 of treatment

• Bolus insulin dose on Day 1 and Day 5 of treatment

  Insulin dose of bolus insulin - on Day 1 and Day 5 of treatment , expressed in IU.

  for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin

• Estimated average glucose on Day 1 and Day 5 of basal bolus insulin treatment - in mg/dl

  Estimated average glucose on Day 1 and Day 5 of basal bolus insulin treatment - in mg/dl

  for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin

• Time in range

  Time in range - as measured on continuous glucose monitor - in percentage

  for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin

• Time above range

  Time above range - as measured on continuous glucose monitor - expressed in percentage

  for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin

• Percent change in coefficient of variation - as measured by continuous glucose monitor - expressed in percentage

  Percent change in coefficient of variation - as measured by continuous glucose monitor - expressed in percentage

  for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin

• Change in Mean amplitude of glycemic excursions (MAGE) - expressed in mg/dl

  MAGE the amplitude of glucose variations over time, calculated using Continuous glucose monitoring data in open source software known as EasyGV - expressed in mg/dl

  for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin

• Change in basal insulin, bolus insulin, and total insulin doses from Day 1 to Day 5 in both groups

  The change in basal insulin, bolus insulin and total insulin dose from Day 1 to Day 5 will be calculated for both glargine and degludec group,

  for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin

Secondary Outcomes (3)

• Incidences of fasting hypoglycemia on any Day, between Day 1 and day 5 of basal bolus treatment, occuring fasting state (early morning, between 5-6 am) - expressed in mg/dl

  for 5 days while admitted in hospital during the clinical trial , from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin

• Incidences of non -fasting (random) hypoglycemia on any Day, between Day 1 and day 5 of basal bolus treatment, occuring in non-fasting states

  for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin

• Time below range

  for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5

Study Arms (2)

Degludec

EXPERIMENTAL

Degludec was used as a basal insulin against active comparator glargine.

Drug: Degludec insulin

Glargine

ACTIVE COMPARATOR

Glargine is an established treatment for glucocorticoid induced hyperglycemia, hence was used as active comparator in this study.

Drug: Glargine insulin

Interventions

Degludec insulin DRUG

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

Degludec

Glargine insulin DRUG

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

Glargine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Non pregnant adult patients
• with or without Type 2 diabetes
• above the age of 18 years
• on glucocorticoid dose equivalent to \>20 mg and \<160 mg prednisolone daily for any indication
• with glucocorticoid induced hyperglycemia (random blood glucose \>200 mg/dl)
• who are requiring basal bolus insulin regimen

Sponsors & Collaborators

• Max Healthcare Insititute Limited: lead

Study Sites (1)

Max Institute of Medical Education

New Delhi, Saket, 110017, India

Location

MeSH Terms

Interventions

insulin degludec; Insulin Glargine

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hospitalized, non pregnant adult patients (above 18 years of age) with or without diabetes, receiving glucocortcoids (prednisolone dose equivalent of 20-160 mg per day) and having glucocorticoid induced hyperglycemia and requiring basal bolus insulin for the management of the same, were randomized to two groups. One group received glargine, and the other degludec insulin as the basal insulin. Both groups received insulin aspart as the bolus. Weight based insulin dosing was done as per study protocol. Patients from both groups were followed for five days, and blood glucose monitoring was done using capillary blood glucose as well as continuous glucose monitoring

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: May 20, 2026
• Study Start: September 1, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

IN (1)