Observational Study to Observe the Safety of NovoMix® 30 Treatment in Patients With Type 2 Diabetes
- Registration Number
- NCT00729898
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in patients with type 2 diabetes during NovoMix® 30 treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 243
Inclusion Criteria
- Any patient with diabetes type 2 diabetes
- Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin
- Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient
Exclusion Criteria
- Known or suspected allergy to study product(s) or related products
- Pregnancy, breast-feeding or intention of becoming pregnant within the next 6 months
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 serious adverse drug reactions, including major hypoglycaemic events after 12 and 26 weeks
- Secondary Outcome Measures
Name Time Method Number of all hypoglycaemic events in the 4 weeks preceding visit, at 12 weeks and the final visit at 26 weeks Number of all adverse drug reactions after 12 and 26 weeks HbA1c at 12 and 26 weeks Variability in fasting plasma glucose (FPG) values and average FPG levels at visits at 12 and 26 weeks Weight changes at visits at 12 and 26 weeks
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇸🇪Farsta, Sweden