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

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ClinicalTrials.gov Identifier: NCT03987802
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: Faster-acting insulin aspart

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: From start of treatment (Week 0) to End of Study Visit (Week 26) ]
    Number of events


Secondary Outcome Measures :
  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 (%)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987802


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03987802     History of Changes
Other Study ID Numbers: NN1218-4489
U1111-1222-9492 ( Other Identifier: World Health Organization (WHO) )
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs