Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®
- Registration Number
- NCT00709683
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 216
Inclusion Criteria
- Type 2 diabetes having failed on basal insulin with or without OAD
- HbA1c greater than 7.0%
Exclusion Criteria
- Subjects being unlikely to comply with protocol requirements
- Subjects who previously enrolled in this study
- Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients
- Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A biphasic insulin aspart 30 -
- Primary Outcome Measures
Name Time Method Incidence of major hypoglycaemic events reported as serious adverse drug reactions during 26 weeks of treatment
- Secondary Outcome Measures
Name Time Method Number of serious adverse drug reactions during 26 weeks of treatment Number of serious adverse events during 26 weeks of treatment Number of all major (daytime and nocturnal) hypoglycaemic events during 26 weeks of treatment Weight (BMI) change from baseline At the end of the study HbA1c change from baseline At the end of the study Number of all minor (daytime and nocturnal) hypoglycaemic events during 26 weeks of treatment Average post-breakfast (90-120 mins), post-lunch (90-120 mins), post-dinner (90-120 mins) plasma glucose level At the end of the study Percentage of patients reaching the target of HbA1c of less than or equal to 7.0% At the end of the study Average (mean) fasting plasma glucose level At the end of the study