China Research of IDEgAsp Treatment in Real-world Clinical practicE (CREATE)

Study Overview
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Brief Summary
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The purpose of this study is to collect information on how Ryzodeg® works in real-world patients. Participants will get Ryzodeg® as prescribed to by their doctor. The study will last for about 5-8 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment

Official Title
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A Prospective Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Ryzodeg® (Insulin Degludec/Insulin Aspart) in a Real-world Adult Population With Type 2 Diabetes in China

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: Signed 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 Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on the approved Ryzodeg® label in China and independently from the decision to include the patient in this study. Male or female, age above or equal to 18 years at the time of signing informed consent. Diagnosed with T2DM and treated with any anti-hyperglycaemic medication(s) other than Ryzodeg® for at least 20 weeks prior to Treatment Initiation Visit (Visit 1). Available and documented Glycosylated haemoglobin (HbA1c) value below or equal to 12 weeks prior to Informed Consent and Treatment Initiation Visit (Visit 1). Exclusion Criteria: Previous participation in this study. Participation is defined as having given informed consent in this study. Treatment with any investigational drug within 30 days prior to enrolment into the study. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. Known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the approved Ryzodeg® label in China.

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 |
| --- | --- |
| Real-world adult population of Chinese patients with T2DM<br>Ryzodec as per local clinical practise | Drug: Ryzodeg®<br>* Patients will be treated with commercially available Ryzodeg® in a prefilled device (FlexTouch®) or in a penfill according to the label and routine clinical practice at the discretion of the treating physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycosylated Haemoglobin (HbA1c) | Percentage point | From baseline (week 0) to end of study (week 20 to 32) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c less than 7 percent (Yes/No) | Percentage of patients | At the end of study (week 20 to 32) | 
| HbA1c less than 7 percent without any hypoglycaemic episodes during 4 weeks prior to end of study (Yes/No) | Percentage of patients | At the end of study (week 20 to 32) Hypoglycaemic episodes occurring within 4 weeks prior to end of study (week 20 to 32). | 
| Change in Fasting Plasma Glucose (FPG) | mmol/L | From baseline (week 0) to end of study (week 20 to 32) | 
| Change in insulin dose (total, basal, prandial) | units/day | From baseline (week 0) to end of study (week 20 to 32) | 
| Change in body weight | Kg | From baseline (week 0) to end of study (week 20 to 32) | 
| Patient preference compared to previous treatment | Percentage of patients who prefer to continue treatment with Ryzodeg® over previous treatment. Assessed by questionnaire | At baseline and end of study (week 20 to 32) | 
| Treatment satisfaction questionnaire (Diabetes Treatment Satisfaction Questionnaire (DTSQ)) | Score based on items 1, 4, 5, 6, 7 and 8. Range 0-36, where higher score means greater satisfaction (better outcome) | At baseline and end of study (week 20 to 32) |