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Completed

NCT Number: NCT05360537

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Internal Medicine Ward, University of Palermo

Palermo, 90127, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin Degludec / Liraglutide Injectable Product

Drug

administration of Insulin Degludec/Liraglutide

Other names: Insulin Degludec/Liraglutide

insulin glargine

Drug

Administration of glargine insulin

Other names: glargine

Primary outcomes

  1. Change of Time in Range % at 7 days, at 1 and 6 months

    Time frame: 7 days, 1 months and 6 months

    Evaluation of Time in Range % by continuous glycemic monitoring

  2. Change of hypoglycemic events

    Time frame: 7 days, 1 months and 6 months

    Change of hypoglycemic events (symptoms and serum glycemia < 60 mg/dl)

  3. Change from Baseline Reactive Hyperemia Index at 3 and 9 months

    Time frame: 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 outcomes

  1. Change from Baseline serum of C- Reactive-Protein (CRP)

    Time frame: 7 days, 1 months and 6 months

    Variation from baseline serum levels of C- Reactive-Protein (CRP) (mg/dl)

  2. Change from Baseline serum levels of Interleukin-6 (IL6)

    Time frame: 7 days, 1 months and 6 months

    Variation from baseline serum levels of Interleukin-6 (IL6) (pg/ml)

  3. Change from Baseline serum levels of ferritin

    Time frame: 7 days, 1 months and 6 months

    Variation from baseline serum levels of ferritin (mcg/L)

  4. Change of intra and extra-hospital mortality

    Time frame: 7 days, 1 months and 6 months

    Change of intra and extra-hospital mortality

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

Effects of Degludec/Liraglutide on Time in Range, Markers of Inflammation and Endothelial Dysfunction Compared to Scheme Insulin Basal Bolus, in a Population of Diabetic Inpatients and Possible Correlation With Intra-hospital Mortality Rates

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 4, 2022
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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