Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3966
Source ID: NCT00659295
Associated Drug: Insulin Detemir
Title: Observational Study to Evaluate the Safety of Levemir® in Diabetes
Acronym: PREDICTIVE™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00659295/results
Conditions: Diabetes|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin detemir
Outcome Measures: Primary: Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events, The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians., Months 0-12 |
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 51170
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2004-06
Completion Date: 2010-03
Results First Posted: 2011-08-16
Last Update Posted: 2017-03-10
Locations: Novo Nordisk Investigational Site, Brussels, 1070, Belgium|Novo Nordisk Investigational Site, Prague, 16000, Czech Republic|Novo Nordisk Investigational Site, Copenhagen S, 2300, Denmark|Novo Nordisk Investigational Site, Espoo, FI-02600, Finland|Novo Nordisk Investigational Site, Paris La défense cedex, 92932, France|Novo Nordisk Investigational Site, Vouliagment, 16671, Greece|Novo Nordisk Investigational Site, Dublin 2, Ireland|Novo Nordisk Investigational Site, Kfar Saba, 44425, Israel|Novo Nordisk Investigational Site, Rome, 00144, Italy|Novo Nordisk Investigational Site, Seoul, 137-920, Korea, Republic of|Novo Nordisk Investigational Site, Malmö, 202 15, Sweden|Novo Nordisk Investigational Site, Istanbul, 34335, Turkey|Novo Nordisk Investigational Site, Crawley, RH11 9RT, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00659295