Diabetes Mellitus, Type 2
Conditions
Keywords
Insulin Degludec/Liraglutide
Brief 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.
Interventions
DRUGInsulin Degludec / Liraglutide Injectable Product
administration of Insulin Degludec/Liraglutide
DRUGInsulin Glargine
Administration of glargine insulin
Sponsors
University of Palermo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Double (Participant, Care Provider)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Time in Range % at 7 days, at 1 and 6 months | 7 days, 1 months and 6 months | Evaluation of Time in Range % by continuous glycemic monitoring |
| Change of hypoglycemic events | 7 days, 1 months and 6 months | Change of hypoglycemic events (symptoms and serum glycemia \< 60 mg/dl) |
| Change from Baseline Reactive Hyperemia Index at 3 and 9 months | 7 days, 1 months and 6 months | Change of Endothelial function by the use of Endopat2000 with the evaluation of Reactive Hypereremia Index (normal value of RHI \> 1,27) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline serum of C- Reactive-Protein (CRP) | 7 days, 1 months and 6 months | Variation from baseline serum levels of C- Reactive-Protein (CRP) (mg/dl) |
| Change of intra and extra-hospital mortality | 7 days, 1 months and 6 months | Change of intra and extra-hospital mortality |
| Change from Baseline serum levels of Interleukin-6 (IL6) | 7 days, 1 months and 6 months | Variation from baseline serum levels of Interleukin-6 (IL6) (pg/ml) |
| Change from Baseline serum levels of ferritin | 7 days, 1 months and 6 months | Variation from baseline serum levels of ferritin (mcg/L) |
Countries
Italy
Outcome results
None listed