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

Sponsor
University of Palermo
Study ID
NCT05360537
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 1, 2021
Status verified
Dec 2023
Primary completion
Dec 1, 2021
Completion
Apr 20, 2022

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: patients treated with Insulin Degludec/Liraglutide
    Diabetes therapy with Insulin Degludec/Liraglutide and various combinations of metformin, repaglinide, sulfonylureas.
  • Active Comparator: patients treated with Insulin regime Basal Bolus
    Diabetes therapy with the combination of a single administration of glargine insulin and three administration of Aspart Insulin.

Primary Outcome Measure

Change of Time in Range % at 7 days, at 1 and 6 months [ Time Frame: 7 days, 1 months and 6 months ]

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