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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05360537
• Other study ID #: U Palermo
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2021
• Est. completion date: April 20, 2022

Study information

• Verified date: December 2023
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 20, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Inflammation

Intervention

Drug:
• Insulin Degludec / Liraglutide Injectable Product
administration of Insulin Degludec/Liraglutide
• Insulin Glargine
Administration of glargine insulin

Locations

Country	Name	City	State
Italy	Internal Medicine Ward, University of Palermo	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change of hypoglycemic events	Change of hypoglycemic events (symptoms and serum glycemia < 60 mg/dl)	7 days, 1 months and 6 months
Primary	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	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
Secondary	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
Secondary	Change from Baseline serum levels of ferritin	Variation from baseline serum levels of ferritin (mcg/L)	7 days, 1 months and 6 months
Secondary	Change of intra and extra-hospital mortality	Change of intra and extra-hospital mortality	7 days, 1 months and 6 months