A Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India

Study Overview
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Brief Summary
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This study is conducted in Asia. The aim of the study is to evaluate long term safety and efficacy of Tresiba® (insulin degludec) in patients with diabetes mellitus in routine clinical practice in India.

Official Title
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A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India

Conditions
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Diabetes, Diabetes Mellitus, Type 1, 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: Informed consent obtained before any study-related activities (Study related activities are any procedure related to recording of data according to the protocol). The historical data including the data before informed consent obtained (e.g. glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), severe hypoglycaemia before the start of Tresiba® therapy) can be used for baseline data Patients with insulin requiring diabetes mellitus and who is scheduled to start treatment with Tresiba® based on the clinical judgment of their treating physician Exclusion Criteria: Known or suspected allergy to Tresiba®, the active substance or any of the excipients Previous participation in this study Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation Patients who are or have previously been on Tresiba® therapy Patients who are participating in other studies or clinical trials Patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
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 |
| --- | --- |
| Patients with diabetes mellitus requiring insulin therapy<br> | Drug: insulin degludec<br>* Treatment according to routine clinical practice at the discretion of the treating physician. The assignment of the patient to Tresiba® is decided in advance of this study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) by preferred term |  | During 1 year of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse events (SAEs) by preferred term |  | During 1 year of treatment | 
| Incidence of serious adverse drug reactions (SADRs) by preferred term |  | During 1 year of treatment | 
| Incidence of adverse drug reactions (ADRs) by preferred term |  | During 1 year of treatment | 
| Incidence of severe hypoglycaemia |  | During 1 year of treatment | 
| Change from baseline in glycosylated haemoglobin (HbA1c) |  | Baseline (Visit 1, week 0), end of study (Visit 4, week 52) | 
| Change from baseline in fasting plasma glucose (FPG) |  | Baseline (Visit 1, week 0), end of study (Visit 4, week 52) | 
| Incidence of confirmed hypoglycaemia |  | During 1 year of treatment |