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

April 3, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500001
        • Care Hospitals
    • Gujarat
      • Ahmedabad, Gujarat, India, 380007
        • Vijayratna Diagnostic & Scientific Obesity Clinic
      • Surat, Gujarat, India, 395002
        • Unique Hospital
    • Haryana
      • Rohtak, Haryana, India, 124001
        • PGIMS Rohtak
    • Karnataka
      • Bangalore, Karnataka, India, 560092
        • Life Care Hospital and Research Centre
      • Bengaluru, Karnataka, India, 560069
        • Karnataka Institute of Endocrinology & Research
      • Mysore, Karnataka, India, 570001
        • Mysore Medical College and Research Institute
    • Kerala
      • Calicut, Kerala, India, 673016
        • Malabar Institute of Medical Sciences Ltd,
      • 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
      • Kolhāpur, 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
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110017
        • Max Super Speciality Hospital, Saket
    • Odisha
      • Khurda, Odisha, 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,
    • Telangana
      • Hyderabad, Telangana, India, 500012
        • Osmania General Hospital
      • Hyderabad, Telangana, India, 500003
        • Gandhi Hospital & Medical college
      • Hyderabad, Telangana, India, 500033
        • Apollo Hospital Jubilee Hills, Hyderabad
    • 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
      • Kolkata, West Bengal, India, 700073
        • Calcutta Medical College

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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