Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Asia. The aim of this observational study is to evaluate the efficacy on blood glucose control while using NovoMix® 30 FlexPen® under normal clinical practice conditions in Korea. A clinical safety profile will be also evaluated.
Interventions
DRUGbiphasic insulin aspart 30
Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any patient with type 1 and type 2 diabetes who are treated with NovoMix® 30 * Patient who signed on informed consent form
Exclusion criteria
* Patients who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit * Patients who were previously enrolled in this study * Patients with a hypersensitivity to NovoMix® 30 or to any of the excipients * Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c change | at the end of study after 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of serious adverse events | during the study |
| Number of all major (daytime and nocturnal) hypoglycaemic events | during the study |
| Number of major hypoglycaemic events related to omission of a meal after NovoMix® 30 injection | during the study |
| Number of major hypoglycaemic events related to physical exercise of at least 30 min | during the study |
| Number of all minor (daytime and nocturnal) hypoglycaemic events | during the study |
| Weight (BMI) change | at the end of study after 26 weeks |
| Number of serious adverse drug reactions | during the study |
| Percentage of patients reaching the target of HbA1c below or equal to 6.5% | at the end of study after 26 weeks |
| Percentage of patients reaching the target of HbA1c below or equal to 7.0% | at the end of study after 26 weeks |
| Percentage of patients reaching the physician's own target recommendation | at the end of study after 26 weeks |
| Variability in fasting plasma glucose values and average (mean) fasting plasma glucose level | at the end of study after 26 weeks |
| Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) plasma glucose level | at the end of study after 26 weeks |
| Diabetes Fear of Self-Injection Questionnaire (D-FISQ) | at the end of study after 26 weeks |
| Lipid profile (Total cholesterol, LDL, HDL, Triglyceride) change | at the end of study after 26 weeks |
Countries
South Korea
Outcome results
None listed