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Clinical Trial Details

Trial ID: L6104
Source ID: NCT02117622
Associated Drug: Insulin Degludec
Title: A Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec
Outcome Measures: Primary: Incidence of adverse events (AEs) by preferred term, During 1 year of treatment | Secondary: Incidence of serious adverse events (SAEs) by preferred term, During 1 year of treatment|Incidence of serious adverse drug reactions (SADRs) by preferred term, During 1 year of treatment|Incidence of adverse drug reactions (ADRs) by preferred term, During 1 year of treatment|Incidence of severe hypoglycaemia, During 1 year of treatment|Change from baseline in glycosylated haemoglobin (HbA1c), Baseline (Visit 1, week 0), end of study (Visit 4, week 52)|Change from baseline in fasting plasma glucose (FPG), Baseline (Visit 1, week 0), end of study (Visit 4, week 52)|Incidence of confirmed hypoglycaemia, During 1 year of treatment
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 1056
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2015-07-24
Completion Date: 2017-04-05
Results First Posted:
Last Update Posted: 2017-08-02
Locations: Novo Nordisk Investigational Site, Guntur, Andhra Pradesh, 522001, India|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500001, India|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500004, India|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500072, India|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, India|Novo Nordisk Investigational Site, Vijayawada, Andhra Pradesh, 520002, India|Novo Nordisk Investigational Site, Guwahati, Assam, 781006, India|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380007, India|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, India|Novo Nordisk Investigational Site, Ghuma, Gujarat, India|Novo Nordisk Investigational Site, Gurgaon, Haryana, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560092, India|Novo Nordisk Investigational Site, Thrissur, Kerala, India|Novo Nordisk Investigational Site, Bhopal, Madhya Pradesh, 462037, India|Novo Nordisk Investigational Site, Indore, Madhya Pradesh, 452010, India|Novo Nordisk Investigational Site, Indore, Madhya Pradesh, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400053, India|Novo Nordisk Investigational Site, Nagpur, Maharashtra, 440010, India|Novo Nordisk Investigational Site, Pune, Maharashtra, 411001, India|Novo Nordisk Investigational Site, Pune, Maharashtra, 411040, India|Novo Nordisk Investigational Site, Pune, Maharashtra, India|Novo Nordisk Investigational Site, Delhi, New Delhi, 110076, India|Novo Nordisk Investigational Site, Delhi, New Delhi, India|Novo Nordisk Investigational Site, Mohali, Punjab, 160062, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600037, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600040, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600086, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600100, India|Novo Nordisk Investigational Site, Coimbatore, Tamil Nadu, 641009, India|Novo Nordisk Investigational Site, Coimbatore, Tamil Nadu, 641018, India|Novo Nordisk Investigational Site, Madurai, Tamil Nadu, 625 020, India|Novo Nordisk Investigational Site, Noida, Uttar Pradesh, 201301, India|Novo Nordisk Investigational Site, Noida, Uttar Pradesh, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700054, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700094, India|Novo Nordisk Investigational Site, Chennai, 600008, India|Novo Nordisk Investigational Site, New Delhi, 110088, India|Novo Nordisk Investigational Site, Thriruvananthapuram, 695 032, India
URL: https://clinicaltrials.gov/show/NCT02117622

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