Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5389
Source ID: NCT00709475
Associated Drug: Insulin Detemir
Title: Observational Safety Study in Subjects Using LevemirĀ® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus
Acronym: LevSafeQD
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, evaluated via number of major hypoglycaemic events, For the duration of the study (32 weeks) | Secondary: Number of serious adverse events, For the duration of the study|Number of all adverse events, For the duration of the study|Number of all - daytime and nocturnal - hypoglycaemic events, In the 4 weeks before baseline compared to 4 weeks before interim and final visits|Weight changes compared to baseline, At the end of the study|HbA1c compared to baseline, At the end of the study|Fasting glucose level control compared to baseline as measured by FBG, After 16 and 32 weeks of treatment
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 747
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2008-05
Completion Date: 2009-10
Results First Posted:
Last Update Posted: 2016-10-28
Locations: Novo Nordisk Investigational Site, Riyadh, 3542, Saudi Arabia
URL: https://clinicaltrials.gov/show/NCT00709475