Effects of Degludec/Liraglutide on Time in Range, Inflammation and Endothelial Function vs Insulin Basal Bolus in Diabetic Inpatients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2; Inflammation
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Insulin Degludec / Liraglutide Injectable Product; Insulin Glargine
Intervention type(s): Drug; Drug
Intervention description(s): administration of Insulin Degludec/Liraglutide; Administration of glargine insulin
Other intervention name(s): Insulin Degludec/Liraglutide; glargine
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Liraglutide; Insulin, Long-Acting; Xultophy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Insulin Degludec/Liraglutide