A Research Study, Looking at How Xultophy® Works in People With Type 2 Diabetes in Local Clinical Practice in United Arab Emirates

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 with type 2 diabetes. The participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 26-34 weeks. The participants will be asked questions about their health and their diabetes treatment as part of their normal study doctor's appointment.

Official Title
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A Multicenter Prospective Non-interventional Study Investigating the Treatment Effect of Xultophy® Intensification in a Real World Population With Type 2 Diabetes in United Arab Emirates

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin degludec/liraglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). The decision to initiate treatment with commercially available Xultophy® has been made by the patient/Legally Acceptable Representative and the treating physician before and independently from the decision to include the patient in this study. Male or female, age greater than or equal to 18 years at the time of signing informed consent. Diagnosed with type 2 diabetes and treated with basal insulin plus or minus oral anti-diabetic drugs (OADs) or Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) plus or minus OADs, except Xultophy®, for at least 12 weeks prior to informed consent and initiation visit (visit 1). Available and documented glycosylated haemoglobin A1c (HbA1c) value less than or equal to 12 weeks prior to initiation of Xultophy® treatment. Exclusion Criteria: Hypersensitivity to the active substance or to any of the excipients as specified in the Xultophy® local label. Previous participation in this study. Participation is defined as having given informed consent in this study. Female who is known pregnant, breast-feeding or intends to become pregnant. Treated with Xultophy® previously. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with type 2 diabetes (T2DM)<br>Patients with T2DM treated with any basal insulin or glucagon-Like peptide-1 receptor agonist (GLP-1 RA) (including once weekly GLP-1 RA) with/without oral antidiabetic drug (OAD) treatment, and with inadequate glycaemic control, for whom the physician had decided to intensify their treatment with Xultophy® | Drug: Insulin degludec/liraglutide<br>* Patients will be treated with Insulin degludec/liraglutide (Xultophy®) at the treating physician's discretion and independent from the decision to include the patient in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in laboratory measured glycosylated haemoglobin A1c (HbA1c) | Measured in % point | From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients reached HbA1c less than 7% at end of study (Yes/No ) | Number of patients who achieved/not achieved HbA1c at end of study: <7.0% | At the end of study visit (26-34 weeks) | 
| Change in laboratory measured fasting plasma glucose (FPG) | Measured in mg/dL | From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks) | 
| Average dose step of Xultophy® at end of the study | Measured in dose steps/day | At the end of study (26-34 weeks) | 
| Change of body weight | Measured in kg | From baseline [≤12 weeks prior to treatment initiation [week 0]) to end of study (26-34 weeks) | 
| Change in number of patient self-reported overall non-severe hypoglycaemic episodes based on recollection | Number of episodes | Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks) | 
| Change in number of patient self-reported nocturnal non-severe hypoglycaemic episodes based on recollection | Number of episodes | Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 4 weeks prior to initiation of treatment with Xultophy® and to within 4 weeks prior to end of study (26-34 weeks) | 
| Change in number of patient self-reported severe hypoglycaemic episodes based on recollection (overall) | Number of episodes | Pre- to post- initiation of treatment with Xultophy®. Episodes occurring within 26 weeks prior to initiation of treatment with Xultophy® and to within 26 weeks prior to end of study (26-34 weeks) | 
| Reason(s) for discontinuing treatment with Xultophy® during the treatment period, if applicable | Pre-specified response option(s) | At the end of study (26-34 weeks) |