Clinical trial

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

Name

NN1218-4489

Description

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.

Trial arms

Trial start

2021-01-20

Estimated PCD

2022-06-28

Trial end

2022-06-28

Status

Completed

Treatment

Faster-acting insulin aspart

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.

Arms:

Fiasp®

Size

Primary endpoint

Adverse Events (AEs)

From start of treatment (Week 0) to End of Study Visit (Week 26)

Eligibility criteria

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 42, 'type': 'ACTUAL'}}

Updated at

2024-03-20

1 organization

1 product

3 indications

Product

Faster-acting insulin aspart

Indication

Indication

Indication

Organization