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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 30 | Drug | Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c change | at the end of study after 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of serious adverse drug reactions | during the study | |
| Number of serious adverse events | during the study | |
| Number of all major (daytime and nocturnal) hypoglycaemic events |
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Inclusion Criteria:
Exclusion Criteria:
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Any patient with type 1 and type 2 diabetes who are prescribed with NovoMix® 30
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Seoul | 137-920 | South Korea |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
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| 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 |
| Lipid profile (Total cholesterol, LDL, HDL, Triglyceride) change | at the end of study after 26 weeks |
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |