Regulatory Post Marketing Surveillance (rPMS) Study of Xultophy® (Insulin Degludec/Liraglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the safety and effectiveness of Xultophy® initiated according to label in adults with type 2 diabetes mellitus (T2DM) under routine clinical practice conditions. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 26 weeks.

Official Title
-----------------
A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Xultophy® (Insulin Degludec / Liraglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Xultophy® (insulin degludec/liraglutide)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The decision to initiate treatment with commercially available Xultophy® has been made by the participant/Legally Acceptable Representative (LAR) and the study doctor before and independently from the decision to include the participant in this study. Informed consent obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. Male or female, age 19 years or older at the time of signing informed consent form. Participants diagnosed (clinically) with T2DM and who is scheduled to start treatment with Xultophy® based on the clinical judgment of their treating physician as specified in the approved Korean-Prescribing information (local label). Exclusion Criteria: Participants who are or have previously been on Xultophy® therapy. Known or suspected hypersensitivity to Xultophy® (the active substance or any of the excipients). Previous participation in this study. Participation is defined as having given informed consent in this study. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Xultophy®<br>Korean adults with type 2 diabetes mellitus (T2DM) initiating Xultophy® under routine clinical practice and according to approved label in Korea. | Drug: Xultophy® (insulin degludec/liraglutide)<br>* Xultophy® is a fixed ratio combination of the long-acting basal insulin, insulin degludec, and the glucagon-like peptide 1 receptor agonist (GLP-1 RA), liraglutide, administered under the skin. Patients will be treated according to routine clinical practice at the discretion of the treating physician according to the label approved by MFDS. The assignment of the patient to Xultophy® is not decided in advance by the protocol but falls within current practice and the prescription of Xultophy® is clearly separated from the decision to include the patient in the study.<br>* Other names: insulin degludec/liraglutide;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) by preferred term | Count of events | baseline (Visit1, 0 week) to 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level 3 hypoglycaemia (severe) or level 2 hypoglycaemia | Plasma Glucose (PG) less than 54 mg/dL (3.0 mmol/L) | Visit1 (0 week) to 26 weeks | 
| Change in body weight | Kilograms | Visit 1 (0 week), Visit 3 (13 weeks) | 
| Change in body weight | kilograms | Visit 1 (0 week), Visit 4 (26 weeks) | 
| Change of Xultophy® dose | Units | Visit 1 (0 week), 13 weeks (Visit 3) | 
| Change of Xultophy® dose | Units | Visit (0 week), Visit 4 (26 weeks) | 
| Change in Glycosylated Haemoglobin (HbA1c) | Percentage | Visit 1 (0 week), Visit 3 (13 weeks) | 
| Change in HbA1c | Percentage | Visit 1 (0 week), Visit 4 (26 weeks) | 
| Individuals achieving HbA1c target less than 7.0 % | Percentage | Visit 1 (0 week), Visit 3 (13 weeks) | 
| Individuals achieving HbA1c target less than 7.0 % | Percentage | Visit 1 (0 week), Visit 4 (26 weeks) | 
| Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) | mg/dl | Visit 1 (0 week), Visit 3 (13 weeks) | 
| Change in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) | mg/dl | Visit 1 (0 week), Visit 4 (26 weeks) | 
| Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) | mg/dl | Visit 1 (0 week), Visit 3 (13 weeks) | 
| Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) | mg/dl | Visit 1 (0 week), Visit 3 (26 weeks) |