A Research Study Looking at Long-term Blood Sugar Control in People With Type 2 Diabetes Being Treated With Xultophy® in a Real-world Setting in Italy

A Prospective, Non-interventional, Single Arm Study Investigating Long-term Glycaemic Control in Patients With Type 2 Diabetes Initiating Xultophy® (IDegLira) in a Realworld Setting in Italy

The purpose of the study is to collect information on how Xultophy® works in patients like them with type 2 diabetes. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 18 months. Participants will be asked questions about their health and diabetes treatment as part of the normal study doctor's appointment.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin degludec and liraglutide (IDegLira)

• Study Type: Observational
• Enrollment (Actual): 359

Contacts and Locations

Study Locations

• Italy
  • Alessandria, Italy, 15121
    • A.O. SS Antonio e Biagio e Cesare Arrigo
  • Ancona, Italy, 60127
    • INRCA
  • Arezzo, Italy, 52100
    • Azienda Sanitaria Usl Toscana Sud Est - Ospedale San Donato
  • Bergamo, Italy, 24127
    • Azienda Ospedaliera Papa Giovanni XXIII
  • Brescia, Italy, 25123
    • ASST OSpedali Civili ad indirizzo Metabolico Diabetologico
  • Carrara, Italy, 54033
    • Centro Polispecialistico Asl Toscana Nord Ovest
  • Casoria, Italy, 80026
    • D.S. 43 Casoria Asl Napoli 2 Nord
  • Catania, Italy, 95126
    • H Cannizzaro Malattie endocrine e del ricambio e nutrizione
  • Feltre, Italy, 32032
    • Ospedale S. Maria del Prato
  • Foggia, Italy, 71122
    • A.O.U. Ospedali Riuniti
  • Francavilla Fontana, Italy, 72021
    • Ospedale Camberlingo
  • Genova, Italy, 16132
    • Ospedale Policlinico San Martino
  • Messina, Italy, 98124
    • A.O.U. Policlinico Martino
  • Napoli, Italy, 80059
    • Asl Napoli 3 Sud
  • Napoli, Italy, 80122
    • PSP Loreto Crispi
  • Oliveto Citra, Italy, 84020
    • Ospedale San Francesco d'Assisi
  • Padova, Italy, 35128
    • Azienda Ospedaliera Padova
  • Pescara, Italy, 65023
    • AUSL Pescara
  • Pistoia, Italy, 51100
    • Ospedale San Jacopo
  • Praia a Mare, Italy, 87028
    • P.O. Praia a Mare ASP Cosenza
  • Roma, Italy, 00161
    • Policlinico Umberto I Clinica Medica DH Diabetologia
  • Roma, Italy, 00174
    • Casa della Salute Antistio
  • Rome, Italy, 00168
    • Policlinico Universitario AGemelli DH Patologie dell'Obesità
  • Salerno, Italy, 84131
    • A.O.U. San Giovanni di Dio e Ruggi D'Aragona
  • San Donà di Piave, Italy, 30027
    • Ospedale San Donà di Piave
  • Udine, Italy, 33100
    • ASUFC Udine
  • LT
    • Latina, LT, Italy, 04100
      • Ospedale Santa Maria Goretti - UOD Diabetologia
  • Pv
    • Pavia, Pv, Italy, 27100
      • ICS Maugeri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Participants are patients with Type 2 Diabetes (T2D) treated with Xultophy® (IDegLira) in a real-world setting in Italy.

Description

Inclusion Criteria:

• Informed consent obtained before any study-related activities (study-related activities include any procedure related to recording of data according to the protocol).
• Male or female, age greater than or equal to 18 years at the time of signing informed consent.
• Patient diagnosed with T2D greater than or equal to 12 months prior to signing informed consent.
• The decision to initiate treatment with commercially available Xultophy® has been made by the patient and the treating physician before and independently from the decision to participate in this study.
• Treated with basal insulin with or without use of oral antidiabetics (OADs), with or without use of bolus insulin prior to initiating Xultophy®.
• For patients transferring from a regimen including bolus insulin, upon initiation of Xultophy® the bolus insulin component of the treatment regimen was stopped.
• The patient initiated Xultophy® treatment for at least 2 months, but no more than 3 months prior to signing informed consent.
• Available and documented HbA1c measurement no more than 3 months prior to Xultophy® initiation.

Exclusion Criteria:

• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
• Diagnosed with type 1 diabetes mellitus, maturity-onset diabetes of the young, latent autoimmune diabetes in adults, gestational diabetes or any hyperglycaemic state other than T2D.
• Women known to be pregnant or breastfeeding, or women planning to become pregnant during the conduct of the study.
• Previous participation in this study. Participation is defined as having given informed consent in this study.
• Participation in another T2D clinical study that involves any clinical intervention or administration of an investigational drug within 3 months prior to enrolment into the study.
• Any contraindications for Xultophy®, including hypersensitivity to the active substances or any of the excipients as specified in the Xultophy® local label.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Xultophy®; Participants are patients with Type 2 Diabetes (T2D) treated with Xultophy® (IDegLira) in a real-world setting in Italy

Drug: Insulin degludec and liraglutide (IDegLira); Paricipants will be treated with commercially available Xultophy® according to routine clinical practice at the discretion of the treating physician, following approved label in Italy. The decision to initiate treatment with commercially available Xultophy® has been made by the patient and the treating physician before and independently from the decision to participate in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycated Haemoglobin (HbA1c)	Percent (%) point Baseline is defined as the time of Xultophy® initiation (V0); if the endpoint variable is unavailable at (V0), the most recent value within 3 months prior to Xultophy® initiation will be used. (This definition of baseline applies to all outcome measures.)	From baseline (V0, month 0) to 6 months after initiation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c		From baseline (V0, month 0) to end of study (V3, 18 ±3 months)
HbA1c levels less than 7% (yes/no)	Percentage of patients - yes	At end of study (V3, 18 ±3 months)
HbA1c levels less than 7% without hypoglycaemic episodes (yes/no)	Percentage of patients - yes	At end of study (V3, 18 ±3 months)
Reason for switching to Xultophy® (precoded question list)	Percentage of patients	At baseline (V0, month 0)
Change in Xultophy® daily dose	Dose steps/day	From baseline (V0, month 0) to end of study (V3, 18 ±3 months)
Number of self-reported non-severe hypoglycaemia episodes (defined as an episode with symptoms and/or self monitored blood glucose (SMBG) value less than or equal to 3.9 mmol/L) based on recollection	Number of episodes	Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit
Number of self-reported nocturnal nonsevere hypoglycaemic episodes (defined based on the patient's perception of whether or not it was night) based on recollection	Number of episodes	Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit
Number of self-reported severe hypoglycaemic episodes (Defined as an episode of hypoglycaemia requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective action) based on recollection	Number of episodes	Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit
Treatment intensification (addition of prandial insulin, increase in total insulin dose or number of concomitant oral antidiabetics (OADs)) (yes/no)	Percentage of patients with treatment intensification	At end of study (V3, 18 ±3 months)
Treatment simplification (decrease in insulin dose or number of concomitant OADs) (yes/no)	Percentage of patients with treatment simplification	At end of study (V3, 18 ±3 months)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2020
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): February 10, 2023

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Glucagon-Like Peptide-1 Receptor Agonists; Liraglutide; Xultophy
• Other Study ID Numbers: NN9068-4740; U1111-1253-1809 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No