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Clinical Trial Details

Trial ID: L5754
Source ID: NCT05360537
Associated Drug: Insulin Degludec / Liraglutide Injectable Product
Title: Effects of Degludec/Liraglutide on Time in Range, Inflammation and Endothelial Function vs Insulin Basal Bolus in Diabetic Inpatients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin Degludec / Liraglutide Injectable Product|DRUG: Insulin Glargine
Outcome Measures: 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|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: 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
Sponsor/Collaborators: Sponsor: University of Palermo
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 100
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2021-04-01
Completion Date: 2022-04-20
Results First Posted:
Last Update Posted: 2023-12-15
Locations: Internal Medicine Ward, University of Palermo, Palermo, 90127, Italy
URL: https://clinicaltrials.gov/show/NCT05360537