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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987802
• Other study ID #: NN1218-4489
• Secondary ID: U1111-1222-9492
• Status: Completed
• Start date: January 20, 2021
• Est. completion date: June 28, 2022

Study information

• Verified date: June 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 28, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
India	Vijayratna Diagnostic & Scientific Obesity Clinic	Ahmedabad	Gujarat
India	Life Care Clinic & Research Centre	Bangalore	Karnataka
India	Pranav Diabetes Centre	Bangalore
India	Post Graduate Institute of Medical Education & Research	Chandigarh	Punjab
India	Kg Hospital and Post Graduate Medical Institute	Coimbatore	Tamil Nadu
India	Max Super Speciality Hospital, Ghaziabad	Ghaziabad	Uttar Pradesh
India	TOTALL Diabetes Hormone Institute	Indore	Madhya Pradesh
India	Santokba Durlabhji Memorial Hospital	Jaipur	Rajasthan
India	Regency Hospital	Kanpur	Uttar Pradesh
India	All India Institute of Medical Sciences (AIIMS), Bhubaneswar	Khurda	Orissa
India	Aster Medcity	Kochi	Kerala
India	Excel Endocrine Centre	Kolhapur	Maharashtra
India	AMRI Hospitals, Dhakuria	Kolkata	West Bengal
India	Apollo Multispeciality Hospital, Kolkata	Kolkata	West Bengal
India	Medanta Lucknow Hospital	Lucknow	Uttar Pradesh
India	Arthur Asirvatham hospital,	Madurai	Tamil Nadu
India	Max Super Speciality Hospital, Mohali	Mohali	Punjab
India	Apollo Hospital, Navi Mumbai	Mumbai	Maharashtra
India	Zandra Healthcare Pvt Ltd	Mumbai	Maharashtra
India	Mysore Medical College and Research Institute	Mysore	Karnataka
India	Dr B L Kapur Memorial Hospital	New Delhi
India	Max Super Speciality Hospital, Saket	New Delhi	Delhi
India	Sir Ganga Ram Hospital-Cardiology	New Delhi
India	chelleram Diabetes Institute	Pune	Maharashtra
India	Siddhi Hospital And Laparoscopy Center Pvt Ltd	Pune	Maharashtra
India	Jothydev's Diabetes & Research Center	Thriruvananthapuram
India	Kerala Institute of Medical Sciences	Trivandrum	Kerala

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

India, 

Outcome

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