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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin Degludec / Liraglutide Injectable Product
* Drug: Insulin Glargine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin Degludec/Liraglutide