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This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart | Drug | Injected subcutaneously (under the skin) twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (glycosylated haemoglobin A1c) |
| Measure | Description | Time Frame |
|---|---|---|
| 8-point blood glucose profiles | ||
| Incidence of hypoglycaemic episodes | ||
| Occurrence of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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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 | Graz | 8036 | Austria | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12027927 | Result | Boehm BO, Home PD, Behrend C, Kamp NM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in Type 1 and Type 2 diabetic patients. Diabet Med. 2002 May;19(5):393-9. doi: 10.1046/j.1464-5491.2002.00733.x. | |
| 11978684 | Result | Lindholm A, Jensen LB, Home PD, Raskin P, Boehm BO, Rastam J. Immune responses to insulin aspart and biphasic insulin aspart in people with type 1 and type 2 diabetes. Diabetes Care. 2002 May;25(5):876-82. doi: 10.2337/diacare.25.5.876. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| biphasic human insulin |
| Drug |
Injected subcutaneously (under the skin) twice daily |
|
| Vienna |
| A 1080 |
| Austria |
| Novo Nordisk Investigational Site | Anklam | 17389 | Germany |
| Novo Nordisk Investigational Site | Berlin | 10559 | Germany |
| Novo Nordisk Investigational Site | Berlin | 14089 | Germany |
| Novo Nordisk Investigational Site | Cottbus | 03048 | Germany |
| Novo Nordisk Investigational Site | Erkner | 15537 | Germany |
| Novo Nordisk Investigational Site | Hamburg | 20251 | Germany |
| Novo Nordisk Investigational Site | Jena | 07743 | Germany |
| Novo Nordisk Investigational Site | Leipzig | 04177 | Germany |
| Novo Nordisk Investigational Site | München | 80804 | Germany |
| Novo Nordisk Investigational Site | Neunkirchen | 66538 | Germany |
| Novo Nordisk Investigational Site | Quakenbrück | 49610 | Germany |
| Novo Nordisk Investigational Site | Rostock | 18057 | Germany |
| Novo Nordisk Investigational Site | Saarlouis | 66740 | Germany |
| Novo Nordisk Investigational Site | Schwedt | 16303 | Germany |
| Novo Nordisk Investigational Site | Ulm | 89081 | Germany |
| Novo Nordisk Investigational Site | Würzburg | 97080 | Germany |
| Novo Nordisk Investigational Site | Cork | Ireland |
| Novo Nordisk Investigational Site | Dublin | DUBLIN 8 | Ireland |
| Novo Nordisk Investigational Site | Dublin | Ireland |
| Novo Nordisk Investigational Site | Bern | 3010 | Switzerland |
| Novo Nordisk Investigational Site | Ayr | KA6 6DX | United Kingdom |
| Novo Nordisk Investigational Site | Bath | BA1 3NG | United Kingdom |
| Novo Nordisk Investigational Site | Birmingham | B9 5SS | United Kingdom |
| Novo Nordisk Investigational Site | Blackburn | BB3 3LR | United Kingdom |
| Novo Nordisk Investigational Site | Bolton | BL1 4QS | United Kingdom |
| Novo Nordisk Investigational Site | Bristol | BS2 8HW | United Kingdom |
| Novo Nordisk Investigational Site | Kettering | NN16 8UZ | United Kingdom |
| Novo Nordisk Investigational Site | Leicester | LE1 5WW | United Kingdom |
| Novo Nordisk Investigational Site | Livingstone | EH54 6PP | United Kingdom |
| Novo Nordisk Investigational Site | Newcastle | NE7 7DN | United Kingdom |
| Novo Nordisk Investigational Site | Northampton | NN1 5BD | United Kingdom |
| Novo Nordisk Investigational Site | Nottingham | NG7 2UH | United Kingdom |
| Novo Nordisk Investigational Site | Paisley | PA2 9PL | United Kingdom |
| Novo Nordisk Investigational Site | Watford | WD18 0HB | United Kingdom |
| Novo Nordisk Investigational Site | Whiston | L35 5DR | United Kingdom |
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| C575870 | biphasic human insulin 30 |
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