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

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

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

NCT03987802•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (26)

Vijayratna Diagnostic & Scientific Obesity Clinic

Ahmedabad, Gujarat, India

Life Care Clinic & Research Centre

Bangalore, Karnataka, India

Mysore Medical College and Research Institute

Mysore, Karnataka, India

Aster Medcity

Kochi, Kerala, India

Kerala Institute of Medical Sciences

Trivandrum, Kerala, India

TOTALL Diabetes Hormone Institute

Indore, Madhya Pradesh, India

Excel Endocrine Centre

Kolhāpur, Maharashtra, India

Zandra Healthcare Pvt Ltd

Mumbai, Maharashtra, India

Apollo Hospital, Navi Mumbai

Mumbai, Maharashtra, India

chelleram Diabetes Institute

Pune, Maharashtra, India

Key Dates

Start Date

January 20, 2021

Primary Completion Date

June 28, 2022

Completion Date

June 28, 2022

Last Updated

September 23, 2024

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Faster-acting insulin aspart

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

Fasted Exercise Training in Type 1 Diabetes (FED-T1D)

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Closed Loop and Education for Hypoglycemia Awareness Restoration

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes