RESILIENT: A Research Study, Looking at How Ryzodeg® Works in People With Type 2 Diabetes in Local Clinical Practice in Japan

Study Overview
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Brief Summary
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The purpose of the study is to collect information on how Ryzodeg® works in real world participants. Participants will get Ryzodeg® as prescribed to them by the study doctor. The study will last for about 6 to 8 months. 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 Prospective Non-interventional Study Investigating the Treatment Effect of Switching From Insulin Glargine to Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real World Adult Population With Type 2 Diabetes in Japan

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin Degludec/Insulin Aspart


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 are any procedures related to recording of data according to the protocol The decision to initiate treatment with commercially available insulin Ryzodeg® 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 more than or equal to 20 years (the legal age of adulthood) at the time of signing informed consent Diagnosed with type 2 diabetes (T2D) for at least 26 weeks prior to signing informed consent Available and documented glycosylated haemoglobin (HbA1c) value less than or equal to 12 weeks prior to initiation of Ryzodeg® treatment For at least 26 weeks prior to initiation of Ryzodeg® treatment, one of the following must apply: A) Treated with insulin glargine (IGlar) (any formulation, including biosimilar IGlar). B) Treated with IGlar (any formulation, including biosimilar IGlar) and IGlar U300 for at least 12 weeks prior to initiation of Ryzodeg® Exclusion Criteria: Previous participation in this study. Participation is defined as signed informed consent. Pregnancy Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation Hypersensitivity to Ryzodeg® or to any of the excipients Previously treated with Ryzodeg®

Ages Eligible for Study
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Minimum Age: 20 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 requiring insulin therapy<br>Patients with type 2 diabetes requiring insulin therapy in Japanese routine clinical practice previously treated with insulin glargine (IGlar) | Drug: Insulin Degludec/Insulin Aspart<br>* Patients will be treated with commercially available Insulin Degludec/Insulin Aspart (Ryzodeg®) in a pre-filled pen injector (FlexTouch®) according to routine clinical practice at the discretion of the treating physician in accordance with the Ryzodeg® label in Japan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in local laboratory measured glycosylated haemoglobin (HbA1c) | Measured in %point | From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study visit or at discontunuation (-2 to +8 weeks at 26 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total insulin dose | Measured in units/day | From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks) | 
| Change in basal insulin dose | Measured in units/day | From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks) | 
| Change in prandial insulin dose | Measured in units/day | From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks) | 
| Change in local laboratory measured fasting plasma glucose (FPG) | Measured in mg/dL | From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study (-2 to +8 weeks at 26 weeks) | 
| The incidence of patient recollection of non-severe hypoglycaemic episodes | Measured in episodes/person-year | Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks) | 
| The incidence of patient recollection of nocturnal non-severe hypoglycaemic episodes | Measured in episodes/person-year | Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks) | 
| The incidence of patient recollection of overall severe hypoglycaemic episodes | Measured in episodes/person-year | Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks) | 
| The incidence of patient recollection of nocturnal severe hypoglycaemic episodes | Measured in episodes/person-year | Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks) | 
| Change in selected patient reported outcomes: Diabetes Therapy Related Quality of Life (DTR-QoL) | Score (on a scale from 0-100, where 100 is the highest health related quality of life (HRQoL)) | From baseline to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks). Baseline defined as visit 1 (week 0) |