Post-Marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ozempic®

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety of long-term treatment with Ozempic® in patients with type 2 diabetes mellitus. People will get Ozempic® as prescribed by their doctor. People will be in this study about 3 years. People above the age of 18 will be asked to fill in the quality of life (QOL) questionnaire (the QOL questionnaire is for the assessment of the influence of diabetes treatment on people's life). There is a possibility that people's blood sample would be provided to Novo Nordisk from their doctors in case of severe allergic reaction that might be caused by Ozempic®.

Official Title
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Post-Marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ozempic®. A Multi-centre, Open-label, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Effectiveness of Ozempic® (Semaglutide) in Japanese Patients With Type 2 Diabetes Mellitus Under Normal Clinical Practice Condition

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: semaglutide


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 Ozempic® 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. Patients with Diabetes Mellitus, Type 2 (T2DM) who the physician has decided to start treatment with Ozempic®. Male or female, no age limitation. 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. Patients who fall under contraindications to the label. Patients who are or have previously been treated with Ozempic®. Female who is pregnant, breast-feeding or intends to become pregnant.
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 |
| --- | --- |
| Ozempic®<br>Japanese people with type 2 diabetes being treated in normal clinical practice conditions | Drug: semaglutide<br>* Patients will be treated with commercially available Ozempic® according to routine clinical practice at the discretion of the treating physician. The treating physician's decision to initiate treatment with Ozempic® is 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 |
| --- | --- | --- |
| Number of adverse events (AEs) | Count | From baseline (day 0) to end of study (month 36) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse reactions (SARs) | Count | From baseline (day 0) to end of study (month 36) | 
| Number of adverse reactions (ARs) | Count | From baseline (day 0) to end of study (month 36) | 
| Number of serious adverse events (SAEs) | Count | From baseline (day 0) to end of study (month 36) | 
| Change in glycosylated haemoglobin A1c (HbA1c) | Percent | From baseline (day 0) to end of study (month 36) | 
| Change in fasting plasma glucose (FPG) | mg/dL | From baseline (day 0) to end of study (month 36) | 
| Change in body weight | kg | From baseline (day 0) to end of study (month 36) | 
| Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - total score | DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: burden on social activities and daily activities, anxiety and dissatisfaction with treatment, hypoglycaemia and satisfaction with treatment. DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1: Strongly agree - 7: Strongly disagree) | From baseline (day 0) to visit 5 (month 12) | 
| Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - burden of social activities and daily activities | DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: burden on social activities and daily activities, anxiety and dissatisfaction with treatment, hypoglycaemia and satisfaction with treatment. DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1: Strongly agree - 7: Strongly disagree) | From baseline (day 0) to visit 5 (month 12) | 
| Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - anxiety and dissatisfaction with treatment | DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: burden on social activities and daily activities, anxiety and dissatisfaction with treatment, hypoglycaemia and satisfaction with treatment. DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1: Strongly agree - 7: Strongly disagree) | From baseline (day 0) to visit 5 (month 12) | 
| Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - hypoglycaemia | DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: burden on social activities and daily activities, anxiety and dissatisfaction with treatment, hypoglycaemia and satisfaction with treatment. DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1: Strongly agree - 7: Strongly disagree) | From baseline (day 0) to visit 5 (month 12) | 
| Change in patient-reported outcomes (PROs) using the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire - satisfaction with treatment | DTR-QOL assesses the influence of diabetes treatment on the individual health related quality of life on 4 domains: burden on social activities and daily activities, anxiety and dissatisfaction with treatment, hypoglycaemia and satisfaction with treatment. DTR-QOL contains 29 items. The response scale used is a 7-point Likert scale (1: Strongly agree - 7: Strongly disagree) | From baseline (day 0) to visit 5 (month 12) |