Observational Study Evaluating the Safety of NovoMix® in Type 2 Diabetes Patients Previously Treated With a Human Premix Insulin
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00775736
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted in Europe. The objective of this observational study is to evaluate the number of serious side effects, when initiating NovoMix® treatment in patients with type 2 diabetes who previously used a human premix insulin under normal clinical practice
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 611
Inclusion Criteria
- Type 2 diabetes mellitus
Exclusion Criteria
- Known or suspected allergy to study product or related products.
- Pregnancy or breastfeeding 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 50 - A biphasic insulin aspart 70 - A biphasic insulin aspart 30 -
- Primary Outcome Measures
Name Time Method The number of serious adverse drug reactions, including major hypoglycaemic episodes, reported during the study period. At baseline, 12 and 26 weeks.
- Secondary Outcome Measures
Name Time Method Number of all hypoglycaemic episodes. At baseline, 12 and 26 weeks. HbA1c at 12 and 26 weeks Weight changes at 12 and 26 weeks Number of all adverse drug reactions. At baseline, 12 and 26 weeks. Evaluation of fasting plasma glucose (FPG) values and postprandial glucose (PPG) levels at 12 and 26 weeks
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇱🇺Luxembourg, Luxembourg