A Study of the Effectiveness of Xultophy® (Insulin Degludec/Liraglutide) in an Adult Real-world Population With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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This study is conducted in Europe. The aim of the study is to investigate the effectiveness of Xultophy® (insulin degludec/liraglutide) in an adult real-world population with type 2 diabetes mellitus.

Official Title
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A European Multi-centre, Retrospective, Non-interventional Study of the Effectiveness of Xultophy® (Insulin Degludec/Liraglutide) in an Adult Real-world Population With Type 2 Diabetes Mellitus

Conditions
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Diabetes, 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 extraction of data according to the protocol) Male or female patients at least 18 years of age at time of informed consent Diagnosis of T2DM (type 2 diabetes mellitus) Xultophy® initiation prescribed at least 6 months before inclusion in this study (i.e., date of signed informed consent). Patients may or may not be continuing Xultophy® at study inclusion Minimum available data:a.) At the time of Xultophy® prescription: HbA1c value (or if unavailable, the most recent HbA1c value within 6 months before the first Xultophy® prescription);b.) At 6 months plus/minus 45 days after first Xultophy® prescription: HbA1c value Exclusion Criteria: Type 1 diabetes Previous participation in this study. Participation is defined as having provided informed consent Participation in a clinical trial within 6 months before or 12 months after the first Xultophy® prescription (Participation in a non-interventional study is not an exclusion criteria) Mental incapacity, unwillingness or inability to provide informed consent, or language barriers precluding adequate understanding or co-operation

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 |
| --- | --- |
| Insulin degludec/liraglutide<br> | Drug: insulin degludec/liraglutide<br>* This is a non-interventional, chart review study and the patients are treated according to current clinical practice and local licenses upon the treating physicians' decision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (Hemoglobin A1c) |  | week 0, week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | Month 0, month 3, month 9, months 12 | 
| Percentage of responders for HbA1c below 7 percent (53 mmol/mol) |  | At 3, 6, 9 and 12 months | 
| Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no weight gain |  | At 3, 6, 9 and 12 months | 
| Percentage of responders for HbA1c below 7 percent (53 mmol/mol) with no hypoglycaemic episodes |  | At 3, 6, 9 and 12 months |