Observational Study of Safety and Effectiveness of NovoMix® 30 for the Treatment of Diabetes
- Registration Number
- NCT00659282
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted in Asia, Europe, Japan and North America. The aim of this observational study is to evaluate the safety and effectiveness while using NovoMix® 30 during 26 weeks under normal clinical practice, in the countries participating in the study. The primary outcome is the incidence of major hypoglycaemic events reported as serious adverse drugs reaction conditions on hypoglycaemic events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57610
Inclusion Criteria
- Age according to approved label and physician discretion
- Type 2 diabetes including newly-diagnosed subjects who have never received insulin or an insulin analogue before
Exclusion Criteria
- Subjects who previously enrolled in this study
- Subjects who are unlikely to comply with protocol requirements
- Hypersensitivity to biphasic insulin aspart or to any of the excipients
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A biphasic insulin aspart biphasic insulin aspart
- Primary Outcome Measures
Name Time Method Incidence of major hypoglycaemic events reported as serious adverse drug reactions during treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇸🇦Riyadh, Saudi Arabia