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
NCT ID: NCT04666987
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
359 participants
OBSERVATIONAL
2020-10-21
2023-02-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Xultophy®
Participants are patients with Type 2 Diabetes (T2D) treated with Xultophy® (IDegLira) in a real-world setting in Italy
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Ospedale Santa Maria Goretti - UOD Diabetologia
Latina, LT, Italy
ICS Maugeri
Pavia, Pv, Italy
A.O. SS Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
INRCA
Ancona, , Italy
Azienda Sanitaria Usl Toscana Sud Est - Ospedale San Donato
Arezzo, , Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
ASST OSpedali Civili ad indirizzo Metabolico Diabetologico
Brescia, , Italy
Centro Polispecialistico Asl Toscana Nord Ovest
Carrara, , Italy
D.S. 43 Casoria Asl Napoli 2 Nord
Casoria, , Italy
H Cannizzaro Malattie endocrine e del ricambio e nutrizione
Catania, , Italy
Ospedale S. Maria del Prato
Feltre, , Italy
A.O.U. Ospedali Riuniti
Foggia, , Italy
Ospedale Camberlingo
Francavilla Fontana, , Italy
Ospedale Policlinico San Martino
Genova, , Italy
A.O.U. Policlinico Martino
Messina, , Italy
ASL Napoli 3 sud
Napoli, , Italy
PSP Loreto Crispi
Napoli, , Italy
Ospedale San Francesco d'Assisi
Oliveto Citra, , Italy
Azienda Ospedaliera Padova
Padua, , Italy
AUSL Pescara
Pescara, , Italy
Ospedale San Jacopo
Pistoia, , Italy
P.O. Praia a Mare ASP Cosenza
Praia a Mare, , Italy
Policlinico Umberto I Clinica Medica DH Diabetologia
Roma, , Italy
Casa della Salute Antistio
Roma, , Italy
Policlinico Universitario AGemelli DH Patologie dell'Obesità
Rome, , Italy
A.O.U. San Giovanni di Dio e Ruggi d'Aragona
Salerno, , Italy
Ospedale San Donà di Piave
San Donà di Piave, , Italy
ASUFC Udine
Udine, , Italy
Countries
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Other Identifiers
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U1111-1253-1809
Identifier Type: OTHER
Identifier Source: secondary_id
NN9068-4740
Identifier Type: -
Identifier Source: org_study_id
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