Observational Study of Type 1 and Type 2 Diabetes Patients Having Switched From Human Premixes to NovoMix®30
Completed
- Conditions
- Diabetes Mellitus, Type 1DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00675493
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoMix® 30 for treatment of type 1 and type 2 diabetes under normal clinical practice conditions in Romania.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 942
Inclusion Criteria
- Type 1 and type 2 diabetics who are treated with human premix insulin (the selection of the subjects will be at the discretion of the individual physician).
Exclusion Criteria
- Subjects currently being treated with biphasic insulin aspart 30
- Subjects who were previously enrolled in this study
- Subjects with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
- Women who are pregnant or have the intention of becoming pregnant within next 6 months
- Children below 10 years of age
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 Change in HbA1c from baseline For the duration of the study
- Secondary Outcome Measures
Name Time Method Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5% after 12 weeks and 24 weeks of treatment Change in FPG (glucose variability) after 12 weeks and 24 weeks of treatment Change in PPG (postprandial control) after 12 weeks and 24 weeks of treatment Change in insulin dose and number of injections at 12 weeks and 24 weeks of treatment Change in oral antidiabetic drug therapy after 12 weeks and 24 weeks of treatment Change in body weight at 12 weeks and 24 weeks of treatment Change in number of hypoglycaemic events during 4 weeks proceeding routine visits at 12 weeks and 24 weeks of treatment Number of adverse drug reactions (ADR) after 12 weeks and 24 weeks of treatment