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Clinical Trial Details

Trial ID: L3430
Source ID: NCT00715663
Associated Drug: Biphasic Insulin Aspart 30
Title: Observational Study to Evaluate Safety, Efficacy and Convenience of Using NovoMix® 30 FlexPen® in Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 2|Delivery Systems
Interventions: DRUG: biphasic insulin aspart 30
Outcome Measures: Primary: Change in HbA1c, after 12 weeks of therapy|Change in post-prandial glucose (PPG), after 12 weeks of therapy|Change in fasting plasma glucose (FPG), after 12 weeks of therapy|Change in prandial glucose increment (PGI), after 12 weeks of therapy|Incidence of hypoglycaemia and other adverse drug reaction, after 12 weeks of therapy|Patient and doctor's convenience, after 12 weeks of therapy | Secondary: Response of different patient profiles to NovoMix 30 therapy and patient profiles considered eligible for insulin treatment in physicians' routine clinical practice, For the duration of the study|Patient satisfaction on devices, after 12 weeks of treatment
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 1584
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2007-02
Completion Date: 2007-12
Results First Posted:
Last Update Posted: 2016-12-13
Locations: Novo Nordisk Investigational Site, Jakarta, 12520, Indonesia
URL: https://clinicaltrials.gov/show/NCT00715663