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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin degludec and liraglutide (IDegLira)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Xultophy®<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | From baseline (V0, month 0) to end of study (V3, 18 ±3 months) | 
| HbA1c levels less than 7% (yes/no) | Percentage of patients - yes | At end of study (V3, 18 ±3 months) | 
| HbA1c levels less than 7% without hypoglycaemic episodes (yes/no) | Percentage of patients - yes | At end of study (V3, 18 ±3 months) | 
| Reason for switching to Xultophy® (precoded question list) | Percentage of patients | At baseline (V0, month 0) | 
| Change in Xultophy® daily dose | Dose steps/day | From baseline (V0, month 0) to end of study (V3, 18 ±3 months) | 
| 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 | Number of episodes | 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 | 
| 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 | Number of episodes | 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 | 
| 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 | Number of episodes | 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 | 
| Treatment intensification (addition of prandial insulin, increase in total insulin dose or number of concomitant oral antidiabetics (OADs)) (yes/no) | Percentage of patients with treatment intensification | At end of study (V3, 18 ±3 months) | 
| Treatment simplification (decrease in insulin dose or number of concomitant OADs) (yes/no) | Percentage of patients with treatment simplification | At end of study (V3, 18 ±3 months) |