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Clinical Trial Details

Trial ID: L4647
Source ID: NCT00665808
Associated Drug: Insulin Detemir
Title: Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-life" Usage in Germany
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin detemir|DRUG: isophane human insulin
Outcome Measures: Primary: treatment satisfaction (DTSQs and DTSQc), over whole study duration, 24 weeks per patient | Secondary: diabetes-related quality of life (ADDQoL), over whole study duration, 24 weeks per patient|general health-related quality of life (EQ-5D), over whole study duration, 24 weeks per patient|Body weight, over whole study duration, 24 weeks per patient|metabolic control (HbA1c, fasting morning blood glucose), over whole study duration, 24 weeks per patient|Insulin dose, over whole study duration, 24 weeks per patient|concomitant diabetes therapy (OADs), over whole study duration, 24 weeks per patient|Hypoglycemia, over whole study duration, 24 weeks per patient|Adverse drug reactions, ADR, over whole study duration, 24 weeks per patient|Serious adverse drug reactions, SADR, over whole study duration, 24 weeks per patient|Pregnancy, over whole study duration, 24 weeks per patient
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 8125
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2007-10
Completion Date: 2008-12
Results First Posted:
Last Update Posted: 2016-10-28
Locations: Novo Nordisk Investigational Site, Mainz, 55127, Germany
URL: https://clinicaltrials.gov/show/NCT00665808