NCT00704223CompletedNot Applicable
Observational Study on Safety and Efficacy in Subjects Using NovoMix® 70 (Biphasic Insulin Aspart) for Treatment of Type 2 Diabetes Mellitus
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 619
- Primary Endpoint
- number of major and minor hypoglycaemic events and adverse events
Study Overview
Brief Summary
This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 70 under normal clinical practice conditions in Austria.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetes
- •HbA1c over 7%
- •No contraindication with NovoMix® 70
Exclusion Criteria
- •Type 1 diabetes
- •Subjects participating in a clinical trial or another observational study
- •Subjects under previous basis-bolus insulin therapy
- •Women who are pregnant, breast feeding and women of child bearing capacity who are not using any reliable contraceptive method
Arms & Interventions
A
Intervention: biphasic insulin aspart (Drug)
Outcomes
Primary Outcomes
number of major and minor hypoglycaemic events and adverse events
Time Frame: 3 months
Secondary Outcomes
- HbA1c(3 months)
- PPBG(3 months)
- FBG(3 months)
Investigators
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