An Indian Post Marketing Study of Mealtime Insulin, Fiasp®, to Evaluate Its Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice

Study Overview
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Brief Summary
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This study is to investigate the effects of Fiasp®, a mealtime insulin, in patients with diabetes mellitus. The purpose of this study is to collect information about Fiasp®, which is prescribed to the participants by their doctors. Participants will administer Fiasp® as prescribed by their doctors. The study will last for about 6 months.

Official Title
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An Indian Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance Study of Fiasp® to Evaluate Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Faster-acting 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 that are carried out as part of the study, including activities to determine suitability for the study. Male or female, age equal to or above 18 years at the time of signing the informed consent. Patients diagnosed with diabetes mellitus. Patients scheduled to start treatment with Fiasp® based on the clinical judgement of their treating physician. Exclusion Criteria: Known or suspected hypersensitivity to study product(s) or related products. Patients on or likely to use insulin pump therapy during the study period Previous participation in this study. Participation is defined as having given signed informed consent. Mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation. Participation in any clinical study of an approved or non-approved investigational medicinal product within 1 month before treatment start. Any disorder which in the opinion of the treating physician may jeopardise the patient's safety or compliance with the protocol.

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 |
| --- | --- |
| Fiasp®<br>Adult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India. | Drug: Faster-acting insulin aspart<br>* Faster-acting insulin aspart given as subcutaneous (s.c., under the skin) injections according to routine clinical practice. The decision to initiate treatment with commercially available Fiasp® must be made by the patient and the treating physician 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 |
| --- | --- | --- |
| Adverse Events (AEs) | Number of events | From start of treatment (Week 0) to End of Study Visit (Week 26) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events (SAEs) | Number of events | From start of treatment (Week 0) to End of Study Visit (Week 26) | 
| Adverse Drug Reactions (ADRs) | Number of events | From start of treatment (Week 0) to End of Study Visit (Week 26) | 
| Serious Adverse Drug Reactions (SADRs) | Number of events | From start of treatment (Week 0) to End of Study Visit (Week 26) | 
| Patient reported severe hypoglycaemia | Episodes/person-year | From start of treatment (Week 0) to End of Study Visit (Week 26) | 
| Patient reported Blood Glucose (BG) confirmed (below 56 mg/dl) hypoglycaemia | Episodes/person-year | From start of treatment (Week 0) to End of Study Visit (Week 26) | 
| Patient reported Severe or BG confirmed (below 56 mg/dl) hypoglycaemia | Episodes/person-year | From start of treatment (Week 0) to End of Study Visit (Week 26) | 
| Change in HbA1c | Percent point (%) | From start of treatment (Week 0) to End of Study Visit (Week 26) |