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This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIAsp 30 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 30 | Drug | Dose individually adjusted, and administered subcutaneously (under the skin) once or twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse drug reactions (SADRs) | Week 26 | |
| Incidence of major hypoglycaemic events | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of all hypoglycaemic events | In the 4 weeks prior to week 12 and week 26, respectively | |
| HbA1c (glycosylated haemoglobin A1c) | Week 26 | |
| Fasting Plasma Glucose (FPG) |
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Inclusion Criteria:
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After the physician has decided to initiate biphasic insulin aspart 30 therapy, any insulin-naïve patient with type 2 diabetes mellitus in need of improved metabolic control, as judged by the treating physician, will be able to participate
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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 | Lund | 221 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21440523 | Result | Berntorp K, Haglund M, Larsen S, Petruckevitch A, Landin-Olsson M; Swedish BIAsp Study Group. Initiation of biphasic insulin aspart 30/70 in subjects with type 2 diabetes mellitus in a largely primary care-based setting in Sweden. Prim Care Diabetes. 2011 Jul;5(2):89-94. doi: 10.1016/j.pcd.2011.02.003. Epub 2011 Mar 26. |
| 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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| Week 26 |