Clinical Trial Details
| Trial ID: | L4966 |
| Source ID: | NCT03987802 |
| Associated Drug: | Faster-Acting Insulin Aspart |
| 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 |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Faster-acting insulin aspart |
| Outcome Measures: | 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)|Adverse Drug Reactions (ADRs), Number of events, From start of treatment (Week 0) to End of Study Visit (Week 26)|Serious Adverse Drug Reactions (SADRs), Number of events, From start of treatment (Week 0) to End of Study Visit (Week 26)|Patient reported severe hypoglycaemia, Episodes/person-year, From start of treatment (Week 0) to End of Study Visit (Week 26)|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)|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)|Change in HbA1c, Percent point (%), From start of treatment (Week 0) to End of Study Visit (Week 26) |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | |
| Enrollment: | 42 |
| Study Type: | OBSERVATIONAL |
| Study Designs: | Observational Model: |Time Perspective: p |
| Start Date: | 2021-01-20 |
| Completion Date: | 2022-06-28 |
| Results First Posted: | |
| Last Update Posted: | 2024-09-23 |
| Locations: | Max Super Speciality Hospital, Saket, New Delhi, Delhi, 110017, India|Vijayratna Diagnostic & Scientific Obesity Clinic, Ahmedabad, Gujarat, 380007, India|Life Care Clinic & Research Centre, Bangalore, Karnataka, 560092, India|Mysore Medical College and Research Institute, Mysore, Karnataka, 570001, India|Aster Medcity, Kochi, Kerala, 682027, India|Kerala Institute of Medical Sciences, Trivandrum, Kerala, 695029, India|TOTALL Diabetes Hormone Institute, Indore, Madhya Pradesh, 452010, India|Excel Endocrine Centre, Kolhapur, Maharashtra, 416008, India|Zandra Healthcare Pvt Ltd, Mumbai, Maharashtra, 400058, India|Apollo Hospital, Navi Mumbai, Mumbai, Maharashtra, 400614, India|chelleram Diabetes Institute, Pune, Maharashtra, 411021, India|Siddhi Hospital And Laparoscopy Center Pvt Ltd, Pune, Maharashtra, 411043, India|All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Khurda, Orissa, 751019, India|Post Graduate Institute of Medical Education & Research, Chandigarh, Punjab, 160012, India|Max Super Speciality Hospital, Mohali, Mohali, Punjab, 160055, India|Santokba Durlabhji Memorial Hospital, Jaipur, Rajasthan, India|Kg Hospital and Post Graduate Medical Institute, Coimbatore, Tamil Nadu, 641018, India|Arthur Asirvatham hospital,, Madurai, Tamil Nadu, 625 020, India|Max Super Speciality Hospital, Ghaziabad, Ghaziabad, Uttar Pradesh, 201012, India|Regency Hospital, Kanpur, Uttar Pradesh, 208006, India|Medanta Lucknow Hospital, Lucknow, Uttar Pradesh, 226030, India|AMRI Hospitals, Dhakuria, Kolkata, West Bengal, 700029, India|Apollo Multispeciality Hospital, Kolkata, Kolkata, West Bengal, 700054, India|Dr B L Kapur Memorial Hospital, New Delhi, 110055, India|Sir Ganga Ram Hospital-Cardiology, New Delhi, 110060, India|Jothydev's Diabetes & Research Center, Thriruvananthapuram, 695 032, India |
| URL: | https://clinicaltrials.gov/show/NCT03987802 |
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