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

NCT05360537 | Completed Phase 4

• 1 other identifier: U Palermo
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Insulin Degludec/Liraglutide

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

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

  7 days, 1 months and 6 months

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

  7 days, 1 months and 6 months

• Change from Baseline serum levels of ferritin

  7 days, 1 months and 6 months

• Change of intra and extra-hospital mortality

  7 days, 1 months and 6 months

Study Arms (2)

patients treated with Insulin Degludec/Liraglutide

EXPERIMENTAL

Diabetes therapy with Insulin Degludec/Liraglutide and various combinations of metformin, repaglinide, sulfonylureas.

Drug: Insulin Degludec / Liraglutide Injectable Product

patients treated with Insulin regime Basal Bolus

ACTIVE COMPARATOR

Diabetes therapy with the combination of a single administration of glargine insulin and three administration of Aspart Insulin.

Drug: Insulin Glargine

Interventions

Insulin Degludec / Liraglutide Injectable Product DRUG

administration of Insulin Degludec/Liraglutide

Also known as: Insulin Degludec/Liraglutide

patients treated with Insulin Degludec/Liraglutide

Insulin Glargine DRUG

Administration of glargine insulin

Also known as: glargine

patients treated with Insulin regime Basal Bolus

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus type 2
• Mild-moderate Hyperglycemia (180-400 mg/dl)
• Acute events (Pneumonia, Acute cardiac Ischemia, Ictus, IVU)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Internal Medicine Ward, University of Palermo

Palermo, 90127, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec; IDegLira; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Antonino Tuttolomondo, Professor

  University of Palermo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double (Participant, Care Provider)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 4, 2022
• Study Start: April 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: April 20, 2022
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

IT (1)