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

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 patients with type 2 diabetes in China. The study will be based on data already recorded in participants' medical records and no new tests or procedures are required as part of the study. This study does not affect participants' current diabetes treatment. The study will look at data recorded in participants' medical records for approximately the last year. After signing the informed consent form, no further activities will be required from the participants.

Official Title
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The Effect of Tresiba® (Insulin Degludec) in Type 2 Diabetes Patients in Real World Clinical Practice in China - Noninterventional, Retrospective Chart Review Study

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Insulin degludec


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Form (ICF) obtained before any study-related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. Male or female, aged at least 18 years at the time of signing the ICF. Diagnosed with T2D. Treated with any OAD(s) or basal insulin ± OAD(s), with or without prandial insulin for at least 20 weeks prior to treatment initiation with Tresiba®. The decision to initiate treatment with commercially available Tresiba® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study. Treated with Tresiba® (with or without OADs, with or without prandial insulin) for at least 20 weeks and have at least one documented medical visit with HbA1c measurement in the first 20 weeks (plus/minus 8 weeks) after Tresiba® initiation. The patient may or may not be treated with Tresiba® at the time of patient selection to this study. Minimum available data: age, weight, and sex at the time of Tresiba® initiation, HbA1c (most recent value within 12 weeks prior to Tresiba® initiation and a value in the first 20 weeks [plus/minus 8 weeks] after Tresiba® treatment), and duration and type of insulin treatment (for insulin treated patients). Exclusion Criteria: Previous participation in this study. Participation is defined as having signed the ICF. Participation (defined as randomisation) in a diabetes clinical trial of an approved or non-approved investigational medicinal product within 20 weeks prior to the treatment initiation with Tresiba® or during the first 28 weeks of treatment with Tresiba®. Tresiba® not used in accordance with the local label. Patients treated with continuous subcutaneous insulin infusion or premix insulin in the 20 weeks prior to receiving Tresiba® (short-term [equal to or less than 14 days] treatment with continuous subcutaneous insulin infusion or premix insulin in the 20 weeks prior to receiving Tresiba® is allowed). Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

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>A broad real world type 2 diabetes (T2D) patient population in China, treated with oral anti-diabetic drugs (OAD(s)) or basal insulin prior to treatment initiation with Tresiba® | Other: Insulin degludec<br>* Participants have been treated with Tresiba® (insulin degludec) for at least 20 weeks before entering the study. The study will be based on data already recorded in participants' medical records for approximately the last year and no new tests or procedures are required as part of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycosylated haemoglobin (HbA1c) | Percent point | Week 0, week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in laboratory-measured fasting plasma glucose (FPG) | mmol/L | From baseline (week 0) to end of study (week 20) | 
| Change in self-measured fasting plasma glucose (SMPG) | mmol/L | From baseline (week 0) to end of study (week 20) | 
| Change in daily insulin doses (total, basal, prandial) | Units/day | From baseline (week 0) to end of study (week 20) | 
| Change in rates of hypoglycaemic episodes (number of episodes/patient years) (overall, nonsevere, severe, nocturnal) before and after add on of/switch to Tresiba® | Count. All recorded events will be captured in the 20 weeks prior to treatment initiation with Tresiba (week 0) and 20 weeks after treatments initiation with Tresiba (week 20) | From baseline (week 0) to end of study (week 20) | 
| Patient having at least one hypoglycaemic episode (overall, non-severe, severe, nocturnal) before and after add-on of/switch to Tresiba® (Yes/no) | Count | From baseline (week 0) to end of study (week 20) | 
| Change in number of concomitant non-insulin anti-diabetic drugs before and after add-on/switch to Tresiba® | Count. All recorded recorded concomitant non-insulin antidiabetic drugs will be captured in the 20 weeks prior to treatment initiation with Tresiba (week 0) and 20 weeks after treatments initiation with Tresiba (week 20) | From baseline (week 0) to end of study (week 20) | 
| Reason(s) for starting Tresiba®, at time of switch/add-on, if available | Free text listing | At baseline (week 20) |