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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.
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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 |
|---|---|---|
| Number of all hypoglycaemic episodes | during 13 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse drug reactions | during 13 weeks of treatment | |
| Number of adverse events | during 13 weeks of treatment | |
| Number of all major hypoglycaemic (daytime and nocturnal) episodes |
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Inclusion Criteria:
Exclusion Criteria:
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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, NovoMix® 50 or NovoMix® 70 or combinations, will be eligible A nonrandomized sample of approximately 325 subjects with Type 2 diabetes mellitus will be enrolled.
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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 | Kfar Saba | 44425 | Israel |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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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| biphasic insulin aspart 50 | Drug | Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation |
|
| biphasic insulin aspart 70 | Drug | Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation |
|
| 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 |
| Weight (BMI) change | at the end of the study after 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 |