Effects of Degludec/Liraglutide on Time in Range, Inflammation and Endothelial Function vs Insulin Basal Bolus in Diabetic Inpatients

What Was Tested

The trial (phase 4) is built around Insulin Glargine and Liraglutide.

The study aims to evaluate the effects of Insulin Degludec/Liraglutide on glycemic variability assessed by continuous glycemic monitoring with the function time in range, serum markers of inflammation, markers of endothelial dysfunction and a possible correlation with intra and extra-hospital mortality rates in a group of hospitalized diabetic patients compared to a control group of in-patient diabetic in treatment on insulin Basal-bolus.

It had two arms (groups): patients treated with Insulin Degludec/Liraglutide (experimental) and patients treated with Insulin regime Basal Bolus (active comparator).

Diabetes therapy with Insulin Degludec/Liraglutide and various combinations of metformin, repaglinide, sulfonylureas.

Diabetes therapy with the combination of a single administration of glargine insulin and three administration of Aspart Insulin.

The registry classes the interventions as drug.

More on the Plan

Giaccone" from April 2022 to April 2024. 50 patients were treated with Insulin Degludec/Liraglutide, 50 were undertaken treatment regime with Insulin Basal Bolus (control group).

The study was carried out in accordance with the principles of the Helsinki Declaration revised in 2001 and all patients gave their written consent to take part in this research.

Each patient treated was compared for age, sex and cardiovascular risk with control patients.

The diagnosis of type 2 diabetes mellitus was based on the revised criteria of the American Diabetes Association (ADA), and using a clinical algorithm that considered the age of onset of the disease, the symptoms and weight present, the family history and the therapy practiced.

Who Took Part

Enrollment: 100 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

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

Examples of who could join: Diabetes mellitus type 2. Acute events (Pneumonia, Acute cardiac Ischemia, Ictus, IVU).

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: diabetes mellitus type 1; diabetic ketoacidosis; hyperosmolar coma.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the participants nor the staff measuring them knew who was on Insulin Glargine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and care provider.

It started in 2021-04-01 with completion listed for 2021-12-01.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change of Time in Range % at 7 days, at 1 and 6 months (time frame: 7 days, 1 months and 6 months). Change of hypoglycemic events (time frame: 7 days, 1 months and 6 months). Change from Baseline Reactive Hyperemia Index at 3 and 9 months (time frame: 7 days, 1 months and 6 months).

It also tracked 4 secondary outcomes, for example Change from Baseline serum of C- Reactive-Protein (CRP), Change from Baseline serum levels of Interleukin-6 (IL6), Change from Baseline serum levels of ferritin and Change of intra and extra-hospital mortality.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Liraglutide in 100 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 and the Liraglutide compound page, all human trials.