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Clinical Trial Details

Trial ID: L5826
Source ID: NCT00755833
Associated Drug: Biphasic Insulin Aspart 50
Title: Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: biphasic insulin aspart 50
Outcome Measures: Primary: Change in HbA1c, At 0, 3, 6, 9, 12 months | Secondary: Percentage of subjects achieving target HbA1c, At 0, 3, 6, 9, 12 months|Change in FPG (fasting plasma glucose), At 0, 3, 6, 9, 12 months|Change in PPG (postprandial glucose), At 0, 3, 6, 9, 12 months|Change in number of hypoglycaemic events, At 0, 3, 6, 9, 12 months|Change in insulin presentation, At 0, 3, 6, 9, 12 months|Dose and number of injections, At 0, 3, 6, 9, 12 months|Number of ADRs (adverse drug reaction), At 0, 3, 6, 9, 12 months
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 270
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2008-09
Completion Date: 2010-04
Results First Posted:
Last Update Posted: 2016-10-31
Locations: Novo Nordisk Investigational Site, Ljubljana, SI-1000, Slovenia
URL: https://clinicaltrials.gov/show/NCT00755833