A Phase 4 interventional study of Insulin Degludec / Liraglutide Injectable Product and Insulin Glargine in Diabetes Mellitus, Type 2, sponsored by University of Palermo. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-12-15.
Sponsored by University of Palermo · Phase 4, Interventional, and Treatment
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.
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 100 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Palermo is the lead sponsor of 145 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
Diabetes therapy with Insulin Degludec/Liraglutide and various combinations of metformin, repaglinide, sulfonylureas.
Drug: Insulin Degludec / Liraglutide Injectable Product
Diabetes therapy with the combination of a single administration of glargine insulin and three administration of Aspart Insulin.
Drug: Insulin Glargine
Drug pages: Insulin degludec · Liraglutide
administration of Insulin Degludec/Liraglutide
Also known as: Insulin Degludec/Liraglutide
Administration of glargine insulin
Also known as: glargine
Change of Time in Range % at 7 days, at 1 and 6 months
Evaluation of Time in Range % by continuous glycemic monitoring
Time frame: 7 days, 1 months and 6 months
Change of hypoglycemic events
Change of hypoglycemic events (symptoms and serum glycemia \< 60 mg/dl)
Time frame: 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)
Time frame: 7 days, 1 months and 6 months
Change from Baseline serum of C- Reactive-Protein (CRP)
Variation from baseline serum levels of C- Reactive-Protein (CRP) (mg/dl)
Time frame: 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)
Time frame: 7 days, 1 months and 6 months
Change from Baseline serum levels of ferritin
Variation from baseline serum levels of ferritin (mcg/L)
Time frame: 7 days, 1 months and 6 months
Change of intra and extra-hospital mortality
Change of intra and extra-hospital mortality
Time frame: 7 days, 1 months and 6 months
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Insulin degludec · Liraglutide