An Indian Post Marketing Study of Mealtime Insulin, Fiasp®, to Evaluate Its Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice
NCT ID: NCT03987802
Last Updated: 2024-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
42 participants
OBSERVATIONAL
2021-01-20
2022-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Fiasp®
Adult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Reporting Anchor and Disclosure (1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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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
Siddhi Hospital And Laparoscopy Center Pvt Ltd
Pune, Maharashtra, India
Max Super Speciality Hospital, Saket
New Delhi, National Capital Territory of Delhi, India
All India Institute of Medical Sciences (AIIMS), Bhubaneswar
Khurda, Odisha, India
Post Graduate Institute of Medical Education & Research
Chandigarh, Punjab, India
Max Super Speciality Hospital, Mohali
Mohali, Punjab, India
Santokba Durlabhji Memorial Hospital
Jaipur, Rajasthan, India
Kg Hospital and Post Graduate Medical Institute
Coimbatore, Tamil Nadu, India
Arthur Asirvatham hospital,
Madurai, Tamil Nadu, India
Max Super Speciality Hospital, Ghaziabad
Ghaziabad, Uttar Pradesh, India
Regency Hospital
Kanpur, Uttar Pradesh, India
Medanta Lucknow Hospital
Lucknow, Uttar Pradesh, India
AMRI Hospitals, Dhakuria
Kolkata, West Bengal, India
Apollo Multispeciality Hospital, Kolkata
Kolkata, West Bengal, India
Dr B L Kapur Memorial Hospital
New Delhi, , India
Sir Ganga Ram Hospital-Cardiology
New Delhi, , India
Jothydev's Diabetes & Research Center
Thriruvananthapuram, , India
Countries
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Other Identifiers
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U1111-1222-9492
Identifier Type: OTHER
Identifier Source: secondary_id
NN1218-4489
Identifier Type: -
Identifier Source: org_study_id
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