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

March 19, 2024 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, India
        • Pranav Diabetes Centre
      • New Delhi, India, 110055
        • Dr B L Kapur Memorial Hospital
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital-Cardiology
      • Thriruvananthapuram, India, 695 032
        • Jothydev's Diabetes & Research Center
    • Delhi
      • New Delhi, Delhi, India, 110017
        • Max Super Speciality Hospital, Saket
    • Gujarat
      • Ahmedabad, Gujarat, India, 380007
        • Vijayratna Diagnostic & Scientific Obesity Clinic
    • Karnataka
      • Bangalore, Karnataka, India, 560092
        • Life Care Clinic & Research Centre
      • Mysore, Karnataka, India, 570001
        • Mysore Medical College and Research Institute
    • Kerala
      • Kochi, Kerala, India, 682027
        • Aster Medcity
      • Trivandrum, Kerala, India, 695029
        • Kerala Institute of Medical Sciences
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • TOTALL Diabetes Hormone Institute
    • Maharashtra
      • Kolhapur, Maharashtra, India, 416008
        • Excel Endocrine Centre
      • Mumbai, Maharashtra, India, 400058
        • Zandra Healthcare Pvt Ltd
      • Mumbai, Maharashtra, India, 400614
        • Apollo Hospital, Navi Mumbai
      • Pune, Maharashtra, India, 411021
        • chelleram Diabetes Institute
      • Pune, Maharashtra, India, 411043
        • Siddhi Hospital And Laparoscopy Center Pvt Ltd
    • Orissa
      • Khurda, Orissa, India, 751019
        • All India Institute of Medical Sciences (AIIMS), Bhubaneswar
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Post Graduate Institute of Medical Education & Research
      • Mohali, Punjab, India, 160055
        • Max Super Speciality Hospital, Mohali
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Santokba Durlabhji Memorial Hospital
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641018
        • Kg Hospital and Post Graduate Medical Institute
      • Madurai, Tamil Nadu, India, 625 020
        • Arthur Asirvatham hospital,
    • Uttar Pradesh
      • Ghaziabad, Uttar Pradesh, India, 201012
        • Max Super Speciality Hospital, Ghaziabad
      • Kanpur, Uttar Pradesh, India, 208006
        • Regency Hospital
      • Lucknow, Uttar Pradesh, India, 226030
        • Medanta Lucknow Hospital
    • West Bengal
      • Kolkata, West Bengal, India, 700054
        • Apollo Multispeciality Hospital, Kolkata
      • Kolkata, West Bengal, India, 700029
        • AMRI Hospitals, Dhakuria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fiasp®
Adult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs)
Time Frame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Number of events
From start of treatment (Week 0) to End of Study Visit (Week 26)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Events (SAEs)
Time Frame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Number of events
From start of treatment (Week 0) to End of Study Visit (Week 26)
Adverse Drug Reactions (ADRs)
Time Frame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Number of events
From start of treatment (Week 0) to End of Study Visit (Week 26)
Serious Adverse Drug Reactions (SADRs)
Time Frame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Number of events
From start of treatment (Week 0) to End of Study Visit (Week 26)
Patient reported severe hypoglycaemia
Time Frame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Episodes/person-year
From start of treatment (Week 0) to End of Study Visit (Week 26)
Patient reported Blood Glucose (BG) confirmed (below 56 mg/dl) hypoglycaemia
Time Frame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Episodes/person-year
From start of treatment (Week 0) to End of Study Visit (Week 26)
Patient reported Severe or BG confirmed (below 56 mg/dl) hypoglycaemia
Time Frame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Episodes/person-year
From start of treatment (Week 0) to End of Study Visit (Week 26)
Change in HbA1c
Time Frame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Percent point (%)
From start of treatment (Week 0) to End of Study Visit (Week 26)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Actual)

June 28, 2022

Study Completion (Actual)

June 28, 2022

Study Registration Dates

First Submitted

June 13, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (Actual)

June 17, 2019

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1218-4489
  • U1111-1222-9492 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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