Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4491
Source ID: NCT02392117
Associated Drug: Insulin Degludec
Title: Investigating the Safety and Effectiveness of Insulin Degludec in a Real World Population With Type 1 and 2 Diabetes Mellitus
Acronym: ReFLeCT
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec
Outcome Measures: Primary: Change in the number of any hypoglycaemic episodes, End of 4 week baseline period, end of 12 month observation period | Secondary: Change from baseline in HbA1c (glycosylated haemoglobin), 0- 12 months|Change from baseline in FPG (Fasting Plasma Glucose), 0-12 months|Change from the baseline period in the number of severe hypoglycaemic episodes, 0-12 months|Change from baseline in HR-QoL (health-related quality of life) questionnaire scores (PROs (patient reported outcome): SF-36 (short form 36), and DTSQ(Diabetes Treatment Satisfaction Questionnaire )), 0-12 months
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 1262
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2015-03-16
Completion Date: 2018-03-19
Results First Posted:
Last Update Posted: 2019-10-02
Locations: Novo Nordisk Investigational Site, Århus, 8200, Denmark|Novo Nordisk Investigational Site, München, 81925, Germany|Novo Nordisk Investigational Site, Padova, 35122, Italy|Novo Nordisk Investigational Site, Utrecht, 3508 GA, Netherlands|Novo Nordisk Investigational Site, Palma de Mallorca, 07015, Spain|Novo Nordisk Investigational Site, Karlstad, 651 85, Sweden|Novo Nordisk Investigational Site, Zürich, 8091, Switzerland|Novo Nordisk Investigational Site, London, SW10 9NH, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02392117

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress