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

NCT04666987 | Completed

• 2 other identifiers: NN9068-4740U1111-1253-1809
• Study Type: observational
• Target: 359
• Locations: 1 country
• Sites: 28

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change in HbA1c

  From baseline (V0, month 0) to end of study (V3, 18 ±3 months)

• HbA1c levels less than 7% (yes/no)

  At end of study (V3, 18 ±3 months)

• HbA1c levels less than 7% without hypoglycaemic episodes (yes/no)

  At end of study (V3, 18 ±3 months)

• Reason for switching to Xultophy® (precoded question list)

  At baseline (V0, month 0)

• Change in Xultophy® daily dose

  From baseline (V0, month 0) to end of study (V3, 18 ±3 months)

Study Arms (1)

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)

Interventions

Insulin degludec and liraglutide (IDegLira) DRUG

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.

Xultophy®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (28)

Ospedale Santa Maria Goretti - UOD Diabetologia

Latina, LT, 04100, Italy

Location

ICS Maugeri

Pavia, Pv, 27100, Italy

Location

A.O. SS Antonio e Biagio e Cesare Arrigo

Alessandria, 15121, Italy

Location

INRCA

Ancona, 60127, Italy

Location

Azienda Sanitaria Usl Toscana Sud Est - Ospedale San Donato

Arezzo, 52100, Italy

Location

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

ASST OSpedali Civili ad indirizzo Metabolico Diabetologico

Brescia, 25123, Italy

Location

Centro Polispecialistico Asl Toscana Nord Ovest

Carrara, 54033, Italy

Location

D.S. 43 Casoria Asl Napoli 2 Nord

Casoria, 80026, Italy

Location

H Cannizzaro Malattie endocrine e del ricambio e nutrizione

Catania, 95126, Italy

Location

Ospedale S. Maria del Prato

Feltre, 32032, Italy

Location

A.O.U. Ospedali Riuniti

Foggia, 71122, Italy

Location

Ospedale Camberlingo

Francavilla Fontana, 72021, Italy

Location

Ospedale Policlinico San Martino

Genova, 16132, Italy

Location

A.O.U. Policlinico Martino

Messina, 98124, Italy

Location

ASL Napoli 3 sud

Napoli, 80059, Italy

Location

PSP Loreto Crispi

Napoli, 80122, Italy

Location

Ospedale San Francesco d'Assisi

Oliveto Citra, 84020, Italy

Location

Azienda Ospedaliera Padova

Padua, 35128, Italy

Location

AUSL Pescara

Pescara, 65023, Italy

Location

Ospedale San Jacopo

Pistoia, 51100, Italy

Location

P.O. Praia a Mare ASP Cosenza

Praia a Mare, 87028, Italy

Location

Policlinico Umberto I Clinica Medica DH Diabetologia

Roma, 00161, Italy

Location

Casa della Salute Antistio

Roma, 00174, Italy

Location

Policlinico Universitario AGemelli DH Patologie dell'Obesità

Rome, 00168, Italy

Location

A.O.U. San Giovanni di Dio e Ruggi d'Aragona

Salerno, 84131, Italy

Location

Ospedale San Donà di Piave

San Donà di Piave, 30027, Italy

Location

ASUFC Udine

Udine, 33100, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec; Liraglutide; IDegLira

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 14, 2020
• Study Start: October 21, 2020
• Primary Completion: December 30, 2022
• Study Completion: February 10, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (28)