Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT03987802
Status:
COMPLETED
Last Update Posted:
2024-09-23
First Post:
2019-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Indian Post Marketing Study of Mealtime Insulin, Fiasp®, to Evaluate Its Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-20', 'studyFirstSubmitDate': '2019-06-13', 'studyFirstSubmitQcDate': '2019-06-13', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events (AEs)', 'timeFrame': 'From start of treatment (Week 0) to End of Study Visit (Week 26)', 'description': 'Number of events'}], 'secondaryOutcomes': [{'measure': 'Serious Adverse Events (SAEs)', 'timeFrame': 'From start of treatment (Week 0) to End of Study Visit (Week 26)', 'description': 'Number of events'}, {'measure': 'Adverse Drug Reactions (ADRs)', 'timeFrame': 'From start of treatment (Week 0) to End of Study Visit (Week 26)', 'description': 'Number of events'}, {'measure': 'Serious Adverse Drug Reactions (SADRs)', 'timeFrame': 'From start of treatment (Week 0) to End of Study Visit (Week 26)', 'description': 'Number of events'}, {'measure': 'Patient reported severe hypoglycaemia', 'timeFrame': 'From start of treatment (Week 0) to End of Study Visit (Week 26)', 'description': 'Episodes/person-year'}, {'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)', 'description': 'Episodes/person-year'}, {'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)', 'description': 'Episodes/person-year'}, {'measure': 'Change in HbA1c', 'timeFrame': 'From start of treatment (Week 0) to End of Study Visit (Week 26)', 'description': 'Percent point (%)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n* Male or female, age equal to or above 18 years at the time of signing the informed consent.\n* Patients diagnosed with diabetes mellitus.\n* Patients scheduled to start treatment with Fiasp® based on the clinical judgement of their treating physician.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to study product(s) or related products.\n* Patients on or likely to use insulin pump therapy during the study period\n* Previous participation in this study. Participation is defined as having given signed informed consent.\n* Mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation.\n* Participation in any clinical study of an approved or non-approved investigational medicinal product within 1 month before treatment start.\n* Any disorder which in the opinion of the treating physician may jeopardise the patient's safety or compliance with the protocol."}, 'identificationModule': {'nctId': 'NCT03987802', 'briefTitle': 'An Indian Post Marketing Study of Mealtime Insulin, Fiasp®, to Evaluate Its Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NN1218-4489'}, 'secondaryIdInfos': [{'id': 'U1111-1222-9492', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fiasp®', 'description': 'Adult patients with diabetes mellitus (type 1 and type 2) under routine clinical practice in India.', 'interventionNames': ['Drug: Faster-acting insulin aspart']}], 'interventions': [{'name': 'Faster-acting insulin aspart', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Fiasp®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '380007', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Vijayratna Diagnostic & Scientific Obesity Clinic', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '560092', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Life Care Clinic & Research Centre', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '570001', 'city': 'Mysore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Mysore Medical College and Research Institute', 'geoPoint': {'lat': 12.29791, 'lon': 76.63925}}, {'zip': '682027', 'city': 'Kochi', 'state': 'Kerala', 'country': 'India', 'facility': 'Aster Medcity', 'geoPoint': {'lat': 9.93988, 'lon': 76.26022}}, {'zip': '695029', 'city': 'Trivandrum', 'state': 'Kerala', 'country': 'India', 'facility': 'Kerala Institute of Medical Sciences', 'geoPoint': {'lat': 8.4855, 'lon': 76.94924}}, {'zip': '452010', 'city': 'Indore', 'state': 'Madhya Pradesh', 'country': 'India', 'facility': 'TOTALL Diabetes Hormone Institute', 'geoPoint': {'lat': 22.71792, 'lon': 75.8333}}, {'zip': '416008', 'city': 'Kolhāpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Excel Endocrine Centre', 'geoPoint': {'lat': 16.69563, 'lon': 74.23167}}, {'zip': '400058', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Zandra Healthcare Pvt Ltd', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400614', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Apollo Hospital, Navi Mumbai', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '411021', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'chelleram Diabetes Institute', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '411043', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Siddhi Hospital And Laparoscopy Center Pvt Ltd', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '110017', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Max Super Speciality Hospital, Saket', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '751019', 'city': 'Khurda', 'state': 'Odisha', 'country': 'India', 'facility': 'All India Institute of Medical Sciences (AIIMS), Bhubaneswar', 'geoPoint': {'lat': 19.26646, 'lon': 83.64513}}, {'zip': '160012', 'city': 'Chandigarh', 'state': 'Punjab', 'country': 'India', 'facility': 'Post Graduate Institute of Medical Education & Research'}, {'zip': '160055', 'city': 'Mohali', 'state': 'Punjab', 'country': 'India', 'facility': 'Max Super Speciality Hospital, Mohali', 'geoPoint': {'lat': 30.67995, 'lon': 76.72211}}, {'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Santokba Durlabhji Memorial Hospital', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '641018', 'city': 'Coimbatore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Kg Hospital and Post Graduate Medical Institute', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'zip': '625 020', 'city': 'Madurai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Arthur Asirvatham hospital,', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}, {'zip': '201012', 'city': 'Ghaziabad', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Max Super Speciality Hospital, Ghaziabad', 'geoPoint': {'lat': 28.66535, 'lon': 77.43915}}, {'zip': '208006', 'city': 'Kanpur', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Regency Hospital', 'geoPoint': {'lat': 26.46523, 'lon': 80.34975}}, {'zip': '226030', 'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Medanta Lucknow Hospital', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '700029', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'AMRI Hospitals, Dhakuria', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '700054', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Apollo Multispeciality Hospital, Kolkata', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '110055', 'city': 'New Delhi', 'country': 'India', 'facility': 'Dr B L Kapur Memorial Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '110060', 'city': 'New Delhi', 'country': 'India', 'facility': 'Sir Ganga Ram Hospital-Cardiology', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '695 032', 'city': 'Thriruvananthapuram', 'country': 'India', 'facility': "Jothydev's Diabetes & Research Center"}], 'overallOfficials': [{'name': 'Clinical Reporting Anchor and Disclosure (1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}