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

University of Palermo

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin Glargine; Drug: Insulin Degludec / Liraglutide Injectable Product

Study type: Interventional

Funder types: Other

Identifiers

NCT05360537

U Palermo

Details and patient eligibility

About

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.

Full description

100 patients with type 2 diabetes mellitus were recruited at the Internal Medicine with Stroke care ward of the University hospital of Palermo "P. 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. Arterial hypertension was defined according to the 2017 ESC-ESH criteria. Dyslipidemia was defined based on total cholesterol levels> 200 mg/dl, triglycerides> 150 mg/dl and HDL levels <40 mg/dl regardless of the patient's gender.

Among the cases enrolled, 135 (100%) had type 2 diabetes mellitus, 110 (80 %) had arterial hypertension and 74 (55%) hypercholesterolemia.

Clinical and anthropometric data were collected at the time of recruitment. Blood samples were taken from each patient (cases and controls) to determine serum glucose, HbA1c, CRP, Ferritin, IL-6. These withdrawals were then repeated three months and six months from the time of recruitment.

The glycemic variability was assessed by continuous glycemic monitoring with the analysis of Time in Range

The digital endothelial function was evaluated through the RHI-pat analysis using Endo-PAT2000.

Enrollment: 100 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes mellitus type 2
• Mild-moderate Hyperglycemia (180-400 mg/dl)
• Acute events (Pneumonia, Acute cardiac Ischemia, Ictus, IVU)

Exclusion criteria

• Diabetes mellitus type 1
• Diabetic ketoacidosis
• Hyperosmolar coma
• Severe hypoglycaemia
• Acute Pancreatitis
• Cancer
• use of corticosteroids
• pregnancy
• Chronic kidney disease (< 30 ml/min) or hemodialysis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

patients treated with Insulin Degludec/Liraglutide

Experimental group

Description:

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

Treatment:

Drug: Insulin Degludec / Liraglutide Injectable Product

patients treated with Insulin regime Basal Bolus

Active Comparator group

Description:

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

Treatment:

Drug: Insulin Glargine