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Clinical Trial Details

Trial ID: L4481
Source ID: NCT02230618
Associated Drug: Insulin Degludec/Insulin Aspart
Title: Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec/Insulin Aspart) 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/insulin aspart
Outcome Measures: Primary: Incidence of Adverse Events (AEs), Weeks 0-52 | Secondary: Serious Adverse Events (SAEs), Weeks 0-52|Serious Adverse Drug Reactions (SADRs), Weeks 0-52|Adverse Drug Reactions (ADRs), Weeks 0-52|Severe or Blood glucose (BG) Confirmed hypoglycaemia, Weeks 0-52|Change in HbA1c (glycosylated haemoglobin), Week 0, week 52|Change in Fasting Plasma Glucose (FPG), Week 0, week 52|Change in Post Prandial Blood/Plasma Glucose (PPBG/PPPG), Week 0, week 52|The reason for initiating or intensifying treatment with Ryzodeg™, Week 0 - week 52
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 1029
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2015-11-24
Completion Date: 2017-06-01
Results First Posted:
Last Update Posted: 2018-03-13
Locations: Novo Nordisk Investigational Site, Guntur, Andhra Pradesh, 522001, India|Novo Nordisk Investigational Site, Vijayawada, Andhra Pradesh, 520002, India|Novo Nordisk Investigational Site, Visakhapatnam, Andhra Pradesh, 530002, India|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380007, India|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380052, India|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, India|Novo Nordisk Investigational Site, Gandhinagar, Gujarat, 382428, India|Novo Nordisk Investigational Site, Ghuma, Gujarat, India|Novo Nordisk Investigational Site, Surat, Gujarat, 395002, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560092, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, India|Novo Nordisk Investigational Site, Mangalore, Karnataka, 575001, India|Novo Nordisk Investigational Site, Angamaly, Kerala, India|Novo Nordisk Investigational Site, Kochi, Kerala, 682041, India|Novo Nordisk Investigational Site, Thrissur, Kerala, India|Novo Nordisk Investigational Site, Trivandrum, Kerala, India|Novo Nordisk Investigational Site, Indore, Madhya Pradesh, 452008, India|Novo Nordisk Investigational Site, Indore, Madhya Pradesh, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400053, India|Novo Nordisk Investigational Site, Pune, Maharashtra, 411001, India|Novo Nordisk Investigational Site, Amritsar, Punjab, India|Novo Nordisk Investigational Site, Chandigarh, Punjab, India|Novo Nordisk Investigational Site, Jaipur, Rajasthan, 302017, India|Novo Nordisk Investigational Site, Jaipur, Rajasthan, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600037, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600100, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, India|Novo Nordisk Investigational Site, Coimbatore, Tamil Nadu, 641009, India|Novo Nordisk Investigational Site, Madurai, Tamil Nadu, 625 020, India|Novo Nordisk Investigational Site, Lucknow, Uttar Pradesh, 226005, India|Novo Nordisk Investigational Site, Lucknow, Uttar Pradesh, India|Novo Nordisk Investigational Site, Noida, Uttar Pradesh, 201301, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700054, India|Novo Nordisk Investigational Site, Bilaspur, 495001, India|Novo Nordisk Investigational Site, Thriruvananthapuram, 695 032, India
URL: https://clinicaltrials.gov/show/NCT02230618

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