Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-06-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India.

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.


Eligibility 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.

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Secondary outcomes:
measure: Serious Adverse Events (SAEs)
timeFrame: From start of treatment (Week 0) to End of Study Visit (Week 26)
measure: Adverse Drug Reactions (ADRs)
timeFrame: From start of treatment (Week 0) to End of Study Visit (Week 26)
measure: Serious Adverse Drug Reactions (SADRs)
timeFrame: From start of treatment (Week 0) to End of Study Visit (Week 26)
measure: Patient reported severe hypoglycaemia
timeFrame: From start of treatment (Week 0) to End of Study Visit (Week 26)
measure: Patient reported Blood Glucose (BG) confirmed (below 56 mg/dl) hypoglycaemia
timeFrame: From start of treatment (Week 0) to End of Study Visit (Week 26)
measure: Patient reported Severe or BG confirmed (below 56 mg/dl) hypoglycaemia
timeFrame: From start of treatment (Week 0) to End of Study Visit (Week 26)
measure: Change in HbA1c
timeFrame: From start of treatment (Week 0) to End of Study Visit (Week 26)
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Max Super Speciality Hospital, Saket
state: Delhi
city: Ahmedabad
country: India
facility: Vijayratna Diagnostic & Scientific Obesity Clinic
state: Gujarat
city: Bangalore
country: India
facility: Life Care Clinic & Research Centre
state: Karnataka
city: Mysore
country: India
facility: Mysore Medical College and Research Institute
state: Karnataka
city: Kochi
country: India
facility: Aster Medcity
state: Kerala
city: Trivandrum
country: India
facility: Kerala Institute of Medical Sciences
state: Kerala
city: Indore
country: India
facility: TOTALL Diabetes Hormone Institute
state: Madhya Pradesh
city: Kolhapur
country: India
facility: Excel Endocrine Centre
state: Maharashtra
city: Mumbai
country: India
facility: Zandra Healthcare Pvt Ltd
state: Maharashtra
city: Mumbai
country: India
facility: Apollo Hospital, Navi Mumbai
state: Maharashtra
city: Pune
country: India
facility: chelleram Diabetes Institute
state: Maharashtra
city: Pune
country: India
facility: Siddhi Hospital And Laparoscopy Center Pvt Ltd
state: Maharashtra
city: Khurda
country: India
facility: All India Institute of Medical Sciences (AIIMS), Bhubaneswar
state: Orissa
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education & Research
state: Punjab
city: Mohali
country: India
facility: Max Super Speciality Hospital, Mohali
state: Punjab
city: Jaipur
country: India
facility: Santokba Durlabhji Memorial Hospital
state: Rajasthan
city: Coimbatore
country: India
facility: Kg Hospital and Post Graduate Medical Institute
state: Tamil Nadu
city: Madurai
country: India
facility: Arthur Asirvatham hospital,
state: Tamil Nadu
city: Ghaziabad
country: India
facility: Max Super Speciality Hospital, Ghaziabad
state: Uttar Pradesh
city: Kanpur
country: India
facility: Regency Hospital
state: Uttar Pradesh
city: Lucknow
country: India
facility: Medanta Lucknow Hospital
state: Uttar Pradesh
city: Kolkata
country: India
facility: AMRI Hospitals, Dhakuria
state: West Bengal
city: Kolkata
country: India
facility: Apollo Multispeciality Hospital, Kolkata
state: West Bengal
city: New Delhi
country: India
facility: Dr B L Kapur Memorial Hospital
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital-Cardiology
city: Thriruvananthapuram
country: India
facility: Jothydev's Diabetes & Research Center
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: