Skip to main content
OpenTrials
Completed

NCT Number: NCT03987802

An Indian Post Marketing Study of Mealtime Insulin, Fiasp®, to Evaluate Its 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CARE Hospitals, Hyderabad, Andhra Pradesh, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Faster-acting insulin aspart

Drug

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.

Primary outcomes

  1. Adverse Events (AEs)

    Time frame: From start of treatment (Week 0) to End of Study Visit (Week 26)

    Number of events

Secondary outcomes

  1. Serious Adverse Events (SAEs)

    Time frame: From start of treatment (Week 0) to End of Study Visit (Week 26)

    Number of events

  2. Adverse Drug Reactions (ADRs)

    Time frame: From start of treatment (Week 0) to End of Study Visit (Week 26)

    Number of events

  3. Serious Adverse Drug Reactions (SADRs)

    Time frame: From start of treatment (Week 0) to End of Study Visit (Week 26)

    Number of events

  4. Patient reported severe hypoglycaemia

    Time frame: From start of treatment (Week 0) to End of Study Visit (Week 26)

    Episodes/person-year

  5. 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

  6. 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

  7. Change in HbA1c

    Time frame: From start of treatment (Week 0) to End of Study Visit (Week 26)

    Percent point (%)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 17, 2019
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.