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

Effects of Degludec/Liraglutide on Time in Range, Markers of Inflammation and Endothelial Dysfunction Compared to Scheme Insulin Basal Bolus, in a Population of Diabetic Inpatients and Possible Correlation With Intra-hospital Mortality Rates

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin Glargine; Drug: Insulin Degludec / Liraglutide Injectable Product

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Palermo, Italy, 90127
    • Internal Medicine Ward, University of Palermo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients treated with Insulin Degludec/Liraglutide; Diabetes therapy with Insulin Degludec/Liraglutide and various combinations of metformin, repaglinide, sulfonylureas.	Drug: Insulin Degludec / Liraglutide Injectable Product; administration of Insulin Degludec/Liraglutide; Other Names: Insulin Degludec/Liraglutide
Active Comparator: patients treated with Insulin regime Basal Bolus; Diabetes therapy with the combination of a single administration of glargine insulin and three administration of Aspart Insulin.	Drug: Insulin Glargine; Administration of glargine insulin; Other Names: glargine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Time in Range % at 7 days, at 1 and 6 months	Evaluation of Time in Range % by continuous glycemic monitoring	7 days, 1 months and 6 months
Change of hypoglycemic events	Change of hypoglycemic events (symptoms and serum glycemia < 60 mg/dl)	7 days, 1 months and 6 months
Change from Baseline Reactive Hyperemia Index at 3 and 9 months	Change of Endothelial function by the use of Endopat2000 with the evaluation of Reactive Hypereremia Index (normal value of RHI > 1,27)	7 days, 1 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline serum of C- Reactive-Protein (CRP)	Variation from baseline serum levels of C- Reactive-Protein (CRP) (mg/dl)	7 days, 1 months and 6 months
Change from Baseline serum levels of Interleukin-6 (IL6)	Variation from baseline serum levels of Interleukin-6 (IL6) (pg/ml)	7 days, 1 months and 6 months
Change from Baseline serum levels of ferritin	Variation from baseline serum levels of ferritin (mcg/L)	7 days, 1 months and 6 months
Change of intra and extra-hospital mortality	Change of intra and extra-hospital mortality	7 days, 1 months and 6 months

Collaborators and Investigators

• Sponsor: University of Palermo
• Investigators: Study Director: Antonino Tuttolomondo, Professor, University of Palermo

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): April 20, 2022

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 9, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Insulin Degludec/Liraglutide
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Insulin; Insulin, Globin Zinc; Insulin, Long-Acting; Liraglutide; Insulin Glargine; Xultophy
• Other Study ID Numbers: U Palermo

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No