Diabetes, Diabetes Mellitus, Type 2
Conditions
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
Interventions
DRUGbiphasic insulin aspart 30
Start dose and frequency and safety data collection at the discretion of the physician following clinical practice
Start dose and frequency and safety data collection at the discretion of the physician following clinical practice
Start dose and frequency and safety data collection at the discretion of the physician following clinical practice
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of serious adverse drug reactions, including major hypoglycaemic episodes, reported during the study period. | At baseline, 12 and 26 weeks. |
Secondary
| Measure | Time frame |
|---|---|
| Number of all hypoglycaemic episodes. | At baseline, 12 and 26 weeks. |
| Number of all adverse drug reactions. | At baseline, 12 and 26 weeks. |
| HbA1c | at 12 and 26 weeks |
| Evaluation of fasting plasma glucose (FPG) values and postprandial glucose (PPG) levels | at 12 and 26 weeks |
| Weight changes | at 12 and 26 weeks |
Countries
Belgium, Luxembourg
Outcome results
None listed