Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Asia. The aim of this observational study is to evaluate the safety profile and clinical effectiveness of using various pre-mixes of Biphasic Insulin Aspart under routine clinical practice conditions in Israel in Type 2 Diabetes patients.
Interventions
DRUGbiphasic insulin aspart 30
Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
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
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30 or NovoMix® 50 or NovoMix® 70 or combinations, will be eligible
Exclusion criteria
* Subjects with a hypersensitivity to biphasic insulin aspart or to any of the excipients. Particular attention should be paid to the drug interactions that are listed within the product local label. * Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of all hypoglycaemic episodes | during 13 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse events | during 13 weeks of treatment |
| Number of all major hypoglycaemic (daytime and nocturnal) episodes | during 13 weeks of treatment |
| Number of all minor and symptomatic (daytime and nocturnal) hypoglycaemic episodes | during 13 weeks of treatment |
| Number of major hypoglycaemic episodes related to omission of a meal after injection | during 13 weeks of treatment |
| Number of major hypoglycaemic episodes related to physical exercise of at least 30 min duration | during 13 weeks of treatment |
| Number of adverse drug reactions | during 13 weeks of treatment |
| HbA1c change | at the end of the study after 13 weeks of treatment |
| Percentage of patients reaching the target of HbA1c of 7.0% or less | at the end of the study after 13 weeks of treatment |
| Variability in fasting blood glucose values and average (mean) fasting blood glucose level | at the end of the study after 13 weeks of treatment |
| Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) blood glucose level | at the end of the study after 13 weeks of treatment |
| Weight (BMI) change | at the end of the study after 13 weeks of treatment |
Countries
Israel
Outcome results
None listed