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

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Treatments: Drug: Faster-acting insulin aspart

Study type: Observational

Funder types: Industry

Identifiers

NCT03987802

U1111-1222-9492 (Other Identifier)

NN1218-4489

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

42 participants in 1 patient group

Fiasp®

Description:

Adult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India.

Treatment:

Drug: Faster-acting insulin aspart