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Clinical Trial Details

Trial ID: L5222
Source ID: NCT00825643
Associated Drug: Insulin Detemir
Title: Observational Study to Evaluate the Safety of LevemirĀ® in Type 2 Diabetes
Acronym: SOLVEā„¢
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin detemir
Outcome Measures: Primary: Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia, during 24 weeks of treatment | Secondary: Incidence of all adverse drug reactions (ADRs), during 24 weeks of treatment|Incidence of major and minor hypoglycaemic events, in the 4 weeks preceding trial start, and at the 12 and 24 week visits|HbA1c and its change from trial start, at the 12 and 24 week visits|Fasting blood glucose (FBG) (average of the self-monitored blood glucose measurements) and its change from trial start, at the 12 and 24 week visits|FBG variability (measured as standard deviation of FBG) and its change from trial start, at the 12 and 24 weeks visits|Body weight and its change from trial start, at the 12 and 24 week visits
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 18481
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2008-04
Completion Date: 2011-03
Results First Posted:
Last Update Posted: 2017-02-13
Locations: Novo Nordisk Investigational Site, Mississauga, L4W 4XI, Canada|Novo Nordisk Investigational Site, Beijing, Beijing, 100004, China|Novo Nordisk Investigational Site, Mainz, 55127, Germany|Novo Nordisk Investigational Site, Kfar Saba, 44425, Israel|Novo Nordisk Investigational Site, Rome, 00144, Italy|Novo Nordisk Investigational Site, Warszawa, PL-02-274, Poland|Novo Nordisk Investigational Site, Paco de Arcos, 2780-730, Portugal|Novo Nordisk Investigational Site, Madrid, 28033, Spain|Novo Nordisk Investigational Site, Istanbul, 34335, Turkey
URL: https://clinicaltrials.gov/show/NCT00825643