Status:
COMPLETED
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
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
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 stu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 10 2023
Estimated Enrollment :
359 Patients enrolled
Trial Details
Trial ID
NCT04666987
Start Date
October 21 2020
End Date
February 10 2023
Last Update
April 3 2024
Active Locations (28)
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1
Ospedale Santa Maria Goretti - UOD Diabetologia
Latina, LT, Italy, 04100
2
ICS Maugeri
Pavia, Pv, Italy, 27100
3
A.O. SS Antonio e Biagio e Cesare Arrigo
Alessandria, Italy, 15121
4
INRCA
Ancona, Italy, 60127