A Study Investigating the Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in South Korea

Study Overview
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Brief Summary
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This is a non-interventional (observational), retrospective medical record review study collecting data reported in medical records of patients with T2D (Type 2 Diabetes ) who were treated with any basal-insulin or premix-insulin (plus/minus OAD (Oral Antidiabetic Drug)) for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg® (plus/minus OAD). All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea.

Official Title
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A Retrospective Multi-centre Non-interventional Study Investigating the Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in South Korea

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Ryzodeg®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age above or equal to 19 years at the time of Ryzodeg® initiation Type 2 diabetes mellitus patients Treated with any basal-insulin (plus/minus OAD (Oral Antidiabetic Drug)) or premix-insulin (plus/minus OAD) for at least 26 weeks prior to switching to Ryzodeg® Treated with Ryzodeg® (plus/minus OAD) for at least 26 weeks after switch from any basal insulin (plus/minus OAD) or premix insulin (plus/minus OAD) At least more than once documented medical visit for 26weeks (plus/minus 6 weeks) after Ryzodeg® initiation Minimum available data : age, type of diabetes at the time of Ryzodeg® initiation, HbA1c [Three values: most recent value within 26 weeks (plus/minus 6 weeks) prior to Ryzodeg® initiation, a value of Ryzodeg® initiation date (plus/minus 6 week), and a value in the first 26 weeks (plus/minus 6 weeks) after Ryzodeg® initiation] The decision to treat with Ryzodeg® was taken by treating physician independently from decision to include patient in study. Exclusion Criteria: Patients treated with any diabetic investigational drug within 26 weeks before or after the initiation of Ryzodeg® Patients switching to Ryzodeg® below 26 weeks prior to the data collection date Patients not treated with any basal-insulin or premix-insulin at least 26 weeks prior to receiving Ryzodeg® Patients treated by continuous subcutaneous insulin infusion prior to receiving Ryzodeg® Pregnancy patient Patients not treated with the local licensed Ryzodeg®

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| Ryzodeg<br>Patients treated with any basal-insulin or premix-insulin for at least 26 weeks prior to switching to Ryzodeg® and treated for at least 26 weeks after switching to Ryzodeg®. | Drug: Ryzodeg®<br>* All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea. Hence independently of this study, the treating physician has determined the starting dose of Ryzodeg® as well as any dose adjustments thereafter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (Glycosylated Hemoglobin) | Percentage point | Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with HbA1c less than 7.0 percentage (Yes or No) | Percentage of patients | At baseline (week 0) | 
| Patients with HbA1c less than 7.0 percentage (Yes or No) | Percentage of patients | End of study (week 26) | 
| Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No) | Percentage of patients | At baseline (week 0) | 
| Patients with HbA1c less than 7 percentage without any hypoglycaemic events during the previous 26 weeks (Yes or No) | Percentage of patients | End of study (week 26) | 
| Difference in the number of overall hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg® | Number of events | Period 1(week-26 to week 0), Period 2(week 0 to week 26) | 
| Difference in the number of severe hypoglycaemia events within 26 weeks before and after the switch to Ryzodeg® | Number of events | Period 1(week-26 to week 0), Period 2(week 0 to week 26) | 
| Change in FPG (Fasting Plasma Glucose) | mmol/L | Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) | 
| Change in daily total insulin dose | Unit/day | Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) | 
| Change in daily basal insulin dose | Unit/day | Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) | 
| Change in daily prandial insulin dose | Unit/day | Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) | 
| Change in body weight | Kg | Period 1 (week -26 to week 0), Period 2 (week 0 to week 26) |