A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Russia

Study Overview
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Brief Summary
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The purpose of the study is to collect information on how Tresiba® works in real world patients with Diabetes Mellitus, Type 2 (type 2 diabetes). Participants will get Tresiba® as prescribed by their doctor. The study will last for around 6 to 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 Study Investigating the Treatment Effect of Tresiba® in Adult Patients With Type 2 Diabetes in Russia

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin degludec


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 Tresiba® has been made by the patient and the treating physician 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 type 2 diabetes and treated with any antihyperglycemic medication(s), except Tresiba® (insulin degludec), for at least 26 weeks prior to Informed consent and Initiation Visit (Visit 1). Available and documented HbA1c value 12 weeks or less prior to initiation of Tresiba® treatment. Exclusion Criteria: 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 Hypersensitivity to the active substance or to any of the excipients as specified in the Tresiba® local label

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 |
| --- | --- |
| Tresiba®<br>Patients with type 2 diabetes | Drug: insulin degludec<br>* Treatment with Tresiba® with or without anti-diabetes medication (as per local label), as prescribed by the participant's physician. The study population will include adult patients with type 2 diabetes, both insulin naïve and previously insulin treated, for whom the treating physician has decided to initiate treatment with Tresiba®, independent of the decision to include the patient in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in laboratory measured glycated haemoglobin (HbA1c) (% point) | % point | From baseline (week -12 to 0) to end of study (week 26-36) | 
| Change in laboratory measured HbA1c (mmol/mol) | mmol/mol | From baseline (week -12 to 0) to end of study (week 26-36) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in laboratory measured fasting plasma glucose (FPG) | mg/dL | From baseline (week -12 to 0) to end of study (week 26-36) | 
| Change in laboratory measured FPG | mmol/L | From baseline (week -12 to 0) to end of study (week 26-36) | 
| Change in daily insulin doses (basal insulin) | units/day | From baseline (week -12 to 0) to end of study (week 26-36) | 
| Change in daily insulin doses (prandial insulin) | units/day | From baseline (week -12 to 0) to end of study (week 26-36) | 
| Change in daily insulin doses (total insulin) | units/day | From baseline (week -12 to 0) to end of study (week 26-36) | 
| Change in number of patient reported overall non-severe hypoglycaemic episodes | Number of episodes | Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36) | 
| Change in number of patient reported nocturnal non-severe hypoglycaemic episodes | Number of episodes | Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36) | 
| Change in number of patient reported severe hypoglycaemic episodes (overall) | Number of episodes | Pre and Post- initiation of treatment with Tresiba®. Episodes occurring within 4 weeks prior to initiation of treatment with Tresiba® (week -12 to 0) and within 4 weeks prior to end of study (week 26 to 36) | 
| Reason(s) for discontinuing treatment with Tresiba® during the treatment period, if applicable (according to pre-specified response options) | Number of participants per response option | After initiation of treatment with Tresiba® (week 0) until treatment discontinuation (week 26-36) |