Observational Study on Safety and Efficacy of Biphasic Insulin Aspart in Type 2 Diabetes Patients
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00834262
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted in Asia. The aim of this observational study is to evaluate the safety profile and clinical effectiveness of using various pre-mixes of Biphasic Insulin Aspart under routine clinical practice conditions in Israel in Type 2 Diabetes patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 339
Inclusion Criteria
- Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30 or NovoMix® 50 or NovoMix® 70 or combinations, will be eligible
Exclusion Criteria
- Subjects with a hypersensitivity to biphasic insulin aspart or to any of the excipients. Particular attention should be paid to the drug interactions that are listed within the product local label.
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 12 months.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A biphasic insulin aspart 50 - A biphasic insulin aspart 30 - A biphasic insulin aspart 70 -
- Primary Outcome Measures
Name Time Method Number of all hypoglycaemic episodes during 13 weeks of treatment
- Secondary Outcome Measures
Name Time Method Number of adverse drug reactions during 13 weeks of treatment Number of all major hypoglycaemic (daytime and nocturnal) episodes during 13 weeks of treatment Number of all minor and symptomatic (daytime and nocturnal) hypoglycaemic episodes during 13 weeks of treatment Weight (BMI) change at the end of the study after 13 weeks of treatment Percentage of patients reaching the target of HbA1c of 7.0% or less at the end of the study after 13 weeks of treatment Number of adverse events during 13 weeks of treatment Number of major hypoglycaemic episodes related to omission of a meal after injection during 13 weeks of treatment HbA1c change at the end of the study after 13 weeks of treatment Variability in fasting blood glucose values and average (mean) fasting blood glucose level at the end of the study after 13 weeks of treatment Number of major hypoglycaemic episodes related to physical exercise of at least 30 min duration during 13 weeks of treatment Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) blood glucose level at the end of the study after 13 weeks of treatment
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇮🇱Kfar Saba, Israel