A Research Study, Looking at How Ryzodeg® (Insulin Degludec/Insulin Aspart) Works in People With Type 2 Diabetes in Local Clinical Practice

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 patients and to see if Ryzodeg® can lower blood sugar levels. Participants will get Ryzodeg® as prescribed to them by their doctor. The study will last for about 6 to 9 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 Multi-centre Prospective Non-interventional Study Investigating the Clinical Effectiveness of Ryzodeg® (Insulin Degludec/Insulin Aspart) in Patients With Type 2 Diabetes Mellitus in a Real-world Setting

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 or switch into treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before, 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 26 weeks prior to signing informed consent. Available and documented HbA1c value for 12 weeks or less prior to signing informed consent. Exclusion Criteria: Hypersensitivity to the active substance or to any of the excipients as specified in the Ryzodeg® local label. Previous participation in this study. Participation is defined as signed informed consent. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. Previous treatment with Ryzodeg®.

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 |
| --- | --- |
| Ryzodeg® as per local practice<br>Real-world population of patients with Diabetes Mellitus, Type 2 (T2DM), who have been initiated or switched to Ryzodeg® from previous antihyperglycaemic treatment according to local clinical practice. | Drug: Insulin Degludec/Insulin Aspart<br>* Insulin Degludec/Insulin Aspart (Ryzodeg®) as prescribed by the patient's treating physician. The decision to initiate or switch into treatment with commercially available Ryzodeg® has been made before, and independently from, the decision to include the patient in this study.<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) | Percentage point | From baseline (week 0) to end of study (week 26-36) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c less than 7% (Yes/No) | Percentage of patients | At the end of study (week 26-36) | 
| HbA1c less than pre-defined individual treatment target (Yes/No) | Percentage of patients | At the end of study (week 26-36) | 
| Change in local laboratory measured fasting plasma glucose (FPG) | mg/dL | From baseline (week 0) to end of study (week 26-36) | 
| Change in local laboratory measured FPG | mmol/L | From baseline (week 0) to end of study (week 26-36) | 
| Change in insulin dose (total, basal, prandial) | units/day | From baseline (week 0) to end of study (week 26-36) | 
| Change in body weight | Kg | From baseline (week 0) to end of study (week 26-36) | 
| Number of patient recollection of non-severe hypoglycaemic episodes | Number of episodes | At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® | 
| Number of patient recollection of non-severe hypoglycaemic episodes | Number of episodes | At the end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study | 
| Number of patient recollection of nocturnal non-severe hypoglycaemic episodes | Number of episodes | At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® | 
| Number of patient recollection of nocturnal non-severe hypoglycaemic episodes | Number of episodes | At end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study | 
| Number of patient recollection of overall severe hypoglycaemic episodes | Number of episodes | At baseline (week 0). Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® | 
| Number of patient recollection of overall severe hypoglycaemic episodes | Number of episodes | At the end of study (week 26-36). Episodes occurring within 26 weeks prior to end of study | 
| Number of weekly self-measured plasma glucose (SMPG) measurements | Number of measurements | At baseline (week 0). Measurements occurring within 7 days prior to initiation of treatment with Ryzodeg® | 
| Number of weekly self-measured plasma glucose (SMPG) measurements | Number of measurements | At end of study (week 26-36). Measurements occurring within 7 days prior to end of study | 
| Reason for initiating Ryzodeg® (pre-specified response option(s)) | Percentage of patients per response option | At baseline (week 0) | 
| Discontinue treatment with Ryzodeg® during the treatment period (Yes/No) | Percentage of patients | At treatment discontinuation (week 0-36) or at end of study (week 26-36). After initiation of treatment with Ryzodeg® until treatment discontinuation | 
| Reason for discontinuing treatment with Ryzodeg® during the treatment period, if applicable, (pre-specified response option(s)) | Percentage of patients per response option | At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation | 
| Time period from initiation to discontinuation of treatment with Ryzodeg® | Days | At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation |