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

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: Faster-acting insulin aspart

• Registration Number: NCT03987802
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-17
• Study Start: 2021-01-20
• Primary Completion: 2022-06-28
• Study Completion: 2022-06-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fiasp®	Faster-acting insulin aspart	Adult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India.

Primary Outcome Measures

Name	Time	Method
Adverse Events (AEs)	From start of treatment (Week 0) to End of Study Visit (Week 26)	Number of events

Secondary Outcome Measures

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

Trial Locations

Locations (26)

Max Super Speciality Hospital, Saket; 🇮🇳 New Delhi, Delhi, India

Vijayratna Diagnostic & Scientific Obesity Clinic; 🇮🇳 Ahmedabad, Gujarat, India

Life Care Clinic & Research Centre; 🇮🇳 Bangalore, Karnataka, India

Mysore Medical College and Research Institute; 🇮🇳 Mysore, Karnataka, India

Aster Medcity; 🇮🇳 Kochi, Kerala, India

Kerala Institute of Medical Sciences; 🇮🇳 Trivandrum, Kerala, India

TOTALL Diabetes Hormone Institute; 🇮🇳 Indore, Madhya Pradesh, India

Excel Endocrine Centre; 🇮🇳 Kolhapur, Maharashtra, India

Zandra Healthcare Pvt Ltd; 🇮🇳 Mumbai, Maharashtra, India

Apollo Hospital, Navi Mumbai; 🇮🇳 Mumbai, Maharashtra, India

chelleram Diabetes Institute; 🇮🇳 Pune, Maharashtra, India

Siddhi Hospital And Laparoscopy Center Pvt Ltd; 🇮🇳 Pune, Maharashtra, India

All India Institute of Medical Sciences (AIIMS), Bhubaneswar; 🇮🇳 Khurda, Orissa, India

Post Graduate Institute of Medical Education & Research; 🇮🇳 Chandigarh, Punjab, India

Max Super Speciality Hospital, Mohali; 🇮🇳 Mohali, Punjab, India

Santokba Durlabhji Memorial Hospital; 🇮🇳 Jaipur, Rajasthan, India

Kg Hospital and Post Graduate Medical Institute; 🇮🇳 Coimbatore, Tamil Nadu, India

Arthur Asirvatham hospital,; 🇮🇳 Madurai, Tamil Nadu, India

Max Super Speciality Hospital, Ghaziabad; 🇮🇳 Ghaziabad, Uttar Pradesh, India

Regency Hospital; 🇮🇳 Kanpur, Uttar Pradesh, India

Medanta Lucknow Hospital; 🇮🇳 Lucknow, Uttar Pradesh, India

AMRI Hospitals, Dhakuria; 🇮🇳 Kolkata, West Bengal, India

Apollo Multispeciality Hospital, Kolkata; 🇮🇳 Kolkata, West Bengal, India

Sir Ganga Ram Hospital-Cardiology; 🇮🇳 New Delhi, India

Dr B L Kapur Memorial Hospital; 🇮🇳 New Delhi, India

Jothydev's Diabetes & Research Center; 🇮🇳 Thriruvananthapuram, India