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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 30 | Drug | Start dose and frequency and safety data collection at the discretion of the physician following clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of serious adverse drug reactions, including major hypoglycaemic episodes, reported during the study period. | At baseline, 12 and 26 weeks. |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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After the participating physicians' decision has been made to initiate NovoMix® therapy, any patient with type 2 diabetes who is currently treated with a human premix insulin therapy.
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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 | Brussels | 1070 | Belgium | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22612579 | Result | Nobels F, D'Hooge D, Crenier L. Switching to biphasic insulin aspart 30/50/70 from biphasic human insulin 30/50 in patients with type 2 diabetes in normal clinical practice: observational study results. Curr Med Res Opin. 2012 Jun;28(6):1017-26. doi: 10.1185/03007995.2012.695730. Epub 2012 Jun 11. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| biphasic insulin aspart 50 | Drug | Start dose and frequency and safety data collection at the discretion of the physician following clinical practice |
|
| biphasic insulin aspart 70 | Drug | Start dose and frequency and safety data collection at the discretion of the physician following clinical practice |
|
| 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 |
| Luxembourg |
| Luxembourg |
| 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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