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

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

Glucocorticoids (GC) represent therapeutic agents of great importance in the treatment and prophylaxis of multiple inflammatory and non-inflammatory conditions.

It had two arms (groups): Degludec (experimental) and Glargine (active comparator).

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

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

The registry classes the interventions as drug.

More on the Plan

The study is being undertaken as a DNB thesis in the Department of Endocrinology under the guidance of Dr.

Glucocorticoids are widely used in hospitalized patients for inflammatory, autoimmune, respiratory, infectious, and malignant conditions.

The study aims to compare insulin glargine, a long-acting basal insulin with approximately 24-hour duration, and insulin degludec, an ultra-long-acting basal insulin with about 42-hour duration.

Secondary objectives include comparing the incidence of hypoglycemia and identifying predictors of glycemic control.

Who Took Part

Enrollment: 79 actual participants took part.

It was open to people of any sex.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Non pregnant adult patients. With or without Type 2 diabetes. Above the age of 18 years. Who are requiring basal bolus insulin regimen.

The full record lists 6 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2023-09-01 with completion listed for 2025-03-31.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Estimated average glucose on Day 1 and Day 5 of basal bolus insulin treatment - in mg/dl (time frame: 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 frame: 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 frame: for 5 days while admitted in hospital, from Day 1 of initiation of basal bolus insulin to Day 5 of basal bolus insulin).

It also tracked 3 secondary outcomes, for example Time below range.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 79 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.