Clinical trial NCT04666987: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-12-14
Enrollment: 359
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Glycated Haemoglobin (HbA1c)
timeFrame: From baseline (V0, month 0) to 6 months after initiation.
Secondary outcomes:
measure: Change in HbA1c
timeFrame: From baseline (V0, month 0) to end of study (V3, 18 ±3 months)
measure: HbA1c levels less than 7% (yes/no)
timeFrame: At end of study (V3, 18 ±3 months)
measure: HbA1c levels less than 7% without hypoglycaemic episodes (yes/no)
timeFrame: At end of study (V3, 18 ±3 months)
measure: Reason for switching to Xultophy® (precoded question list)
timeFrame: At baseline (V0, month 0)
measure: Change in Xultophy® daily dose
timeFrame: From baseline (V0, month 0) to end of study (V3, 18 ±3 months)
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: Treatment intensification (addition of prandial insulin, increase in total insulin dose or number of concomitant oral antidiabetics (OADs)) (yes/no)
timeFrame: At end of study (V3, 18 ±3 months)
measure: Treatment simplification (decrease in insulin dose or number of concomitant OADs) (yes/no)
timeFrame: At end of study (V3, 18 ±3 months)
Other outcomes:
Locations:
city: Latina
country: Italy
facility: Ospedale Santa Maria Goretti - UOD Diabetologia
state: LT
city: Pavia
country: Italy
facility: ICS Maugeri
state: Pv
city: Alessandria
country: Italy
facility: A.O. SS Antonio e Biagio e Cesare Arrigo
city: Ancona
country: Italy
facility: INRCA
city: Arezzo
country: Italy
facility: Azienda Sanitaria Usl Toscana Sud Est - Ospedale San Donato
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Brescia
country: Italy
facility: ASST OSpedali Civili ad indirizzo Metabolico Diabetologico
city: Carrara
country: Italy
facility: Centro Polispecialistico Asl Toscana Nord Ovest
city: Casoria
country: Italy
facility: D.S. 43 Casoria Asl Napoli 2 Nord
city: Catania
country: Italy
facility: H Cannizzaro Malattie endocrine e del ricambio e nutrizione
city: Feltre
country: Italy
facility: Ospedale S. Maria del Prato
city: Foggia
country: Italy
facility: A.O.U. Ospedali Riuniti
city: Francavilla Fontana
country: Italy
facility: Ospedale Camberlingo
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Messina
country: Italy
facility: A.O.U. Policlinico Martino
city: Napoli
country: Italy
facility: ASL Napoli 3 sud
city: Napoli
country: Italy
facility: PSP Loreto Crispi
city: Oliveto Citra
country: Italy
facility: Ospedale San Francesco d'Assisi
city: Padova
country: Italy
facility: Azienda Ospedaliera Padova
city: Pescara
country: Italy
facility: AUSL Pescara
city: Pistoia
country: Italy
facility: Ospedale San Jacopo
city: Praia a Mare
country: Italy
facility: P.O. Praia a Mare ASP Cosenza
city: Roma
country: Italy
facility: Policlinico Umberto I Clinica Medica DH Diabetologia
city: Roma
country: Italy
facility: Casa della Salute Antistio
city: Rome
country: Italy
facility: Policlinico Universitario AGemelli DH Patologie dell'Obesità
city: Salerno
country: Italy
facility: A.O.U. San Giovanni di Dio e Ruggi d'Aragona
city: San Donà di Piave
country: Italy
facility: Ospedale San Donà di Piave
city: Udine
country: Italy
facility: ASUFC Udine
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References: