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
2 other identifiers
observational
42
1 country
36
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2021
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2019
CompletedFirst Posted
Study publicly available on registry
June 17, 2019
CompletedStudy Start
First participant enrolled
January 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2022
CompletedApril 9, 2026
April 1, 2026
1.4 years
June 13, 2019
April 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Events (AEs)
Number of events
From start of treatment (Week 0) to End of Study Visit (Week 26)
Secondary Outcomes (7)
Serious Adverse Events (SAEs)
From start of treatment (Week 0) to End of Study Visit (Week 26)
Adverse Drug Reactions (ADRs)
From start of treatment (Week 0) to End of Study Visit (Week 26)
Serious Adverse Drug Reactions (SADRs)
From start of treatment (Week 0) to End of Study Visit (Week 26)
Patient reported severe hypoglycaemia
From start of treatment (Week 0) to End of Study Visit (Week 26)
Patient reported Blood Glucose (BG) confirmed (below 56 mg/dl) hypoglycaemia
From start of treatment (Week 0) to End of Study Visit (Week 26)
- +2 more secondary outcomes
Study Arms (1)
Fiasp®
Adult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India.
Interventions
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.
Eligibility Criteria
Adult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (36)
CARE Hospitals
Hyderabad, Andhra Pradesh, 500001, India
Vijayratna Diagnostic & Scientific Obesity Clinic
Ahmedabad, Gujarat, 380007, India
Unique Hospital
Surat, Gujarat, 395002, India
PGIMS Rohtak
Rohtak, Haryana, 124001, India
Life Care Hospital and Research Centre
Bangalore, Karnataka, 560092, India
Karnataka Institute of Endocrinology & Research
Bengaluru, Karnataka, 560069, India
Mysore Medical College and Research Institute
Mysore, Karnataka, 570001, India
Malabar Institute of Medical Sciences Ltd,
Calicut, Kerala, 673016, India
Aster Medcity
Kochi, Kerala, 682027, India
Kerala Institute of Medical Sciences
Trivandrum, Kerala, 695029, India
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, 452010, India
Excel Endocrine Centre
Kolhāpur, Maharashtra, 416008, India
Zandra Healthcare Pvt Ltd
Mumbai, Maharashtra, 400058, India
Apollo Hospital, Navi Mumbai
Mumbai, Maharashtra, 400614, India
chelleram Diabetes Institute
Pune, Maharashtra, 411021, India
Siddhi Hospital And Laparoscopy Center Pvt Ltd
Pune, Maharashtra, 411043, India
Max Super Speciality Hospital, Saket
New Delhi, National Capital Territory of Delhi, 110017, India
All India Institute of Medical Sciences (AIIMS), Bhubaneswar
Khurda, Odisha, 751019, India
Post Graduate Institute of Medical Education & Research
Chandigarh, Punjab, 160012, India
Max Super Speciality Hospital, Mohali
Mohali, Punjab, 160055, India
Santokba Durlabhji Memorial Hospital
Jaipur, Rajasthan, India
Kg Hospital and Post Graduate Medical Institute
Coimbatore, Tamil Nadu, 641018, India
Arthur Asirvatham hospital,
Madurai, Tamil Nadu, 625 020, India
Gandhi Hospital & Medical college
Hyderabad, Telangana, 500003, India
Osmania General Hospital
Hyderabad, Telangana, 500012, India
Apollo Hospital Jubilee Hills, Hyderabad
Hyderabad, Telangana, 500033, India
Max Super Speciality Hospital, Ghaziabad
Ghaziabad, Uttar Pradesh, 201012, India
Regency Hospital
Kanpur, Uttar Pradesh, 208006, India
Medanta Lucknow Hospital
Lucknow, Uttar Pradesh, 226030, India
AMRI Hospitals, Dhakuria
Kolkata, West Bengal, 700029, India
Apollo Multispeciality Hospital, Kolkata
Kolkata, West Bengal, 700054, India
Calcutta Medical College
Kolkata, West Bengal, 700073, India
Pranav Diabetes Centre
Bangalore, India
Dr B L Kapur Memorial Hospital
New Delhi, 110055, India
Sir Ganga Ram Hospital-Cardiology
New Delhi, 110060, India
Jothydev's Diabetes & Research Center
Thriruvananthapuram, 695 032, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2019
First Posted
June 17, 2019
Study Start
January 20, 2021
Primary Completion
June 28, 2022
Study Completion
June 28, 2022
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com