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

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin degludec and liraglutide (IDegLira)

Study type: Observational

Funder types: Industry

Identifiers

NCT04666987

U1111-1253-1809 (Other Identifier)

NN9068-4740

Details and patient eligibility

About

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.

Enrollment: 359 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

359 participants in 1 patient group

Xultophy®

Description:

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

Treatment:

Drug: Insulin degludec and liraglutide (IDegLira)