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This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with 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 | Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (glycolated haemoglobin) |
| Measure | Description | Time Frame |
|---|---|---|
| Prandial increment in blood glucose | ||
| 7-point blood glucose profile | ||
| Number and severity 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 | Århus C | 8000 | Denmark | |||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| biphasic human insulin | Drug | Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily |
|
| Number and severity of local tolerability issues at the injection site |
| Number and severity of hypoglycaemic episodes |
| Esbjerg |
| 6700 |
| Denmark |
| Novo Nordisk Investigational Site | Herning | 7400 | Denmark |
| Novo Nordisk Investigational Site | Holbæk | 4300 | Denmark |
| Novo Nordisk Investigational Site | Næstved | 4700 | Denmark |
| Novo Nordisk Investigational Site | Randers | Denmark |
| Novo Nordisk Investigational Site | Silkeborg | 8600 | Denmark |
| Novo Nordisk Investigational Site | Skive | 7800 | Denmark |
| Novo Nordisk Investigational Site | Viborg | Denmark |
| Novo Nordisk Investigational Site | Åsgårdstrand | Norway |
| Novo Nordisk Investigational Site | Bekkestua | 1357 | Norway |
| Novo Nordisk Investigational Site | Bergen | NO-5012 | Norway |
| Novo Nordisk Investigational Site | Haugesund | Norway |
| Novo Nordisk Investigational Site | Hønefoss | Norway |
| Novo Nordisk Investigational Site | Moelv | Norway |
| Novo Nordisk Investigational Site | Oslo | 0370 | Norway |
| Novo Nordisk Investigational Site | Tromsø | 9038 | Norway |
| Novo Nordisk Investigational Site | Vennesla | Norway |
| Novo Nordisk Investigational Site | Arvika | 671 80 | Sweden |
| Novo Nordisk Investigational Site | Avesta | 774 82 | Sweden |
| Novo Nordisk Investigational Site | Bjuv | 267 38 | Sweden |
| Novo Nordisk Investigational Site | Broby | 280 60 | Sweden |
| Novo Nordisk Investigational Site | Färgelanda | 458 32 | Sweden |
| Novo Nordisk Investigational Site | Gothenburg | 416 65 | Sweden |
| Novo Nordisk Investigational Site | Gothenburg | 416 85 | Sweden |
| Novo Nordisk Investigational Site | Gothenburg | 417 02 | Sweden |
| Novo Nordisk Investigational Site | Gothenburg | 417 17 | Sweden |
| Novo Nordisk Investigational Site | Grästorp | 467 22 | Sweden |
| Novo Nordisk Investigational Site | Habo | 566 32 | Sweden |
| Novo Nordisk Investigational Site | Härnösand | 871 82 | Sweden |
| Novo Nordisk Investigational Site | Hässleholm | 281 25 | Sweden |
| Novo Nordisk Investigational Site | Helsingborg | 254 57 | Sweden |
| Novo Nordisk Investigational Site | Jönköping | 551 11 | Sweden |
| Novo Nordisk Investigational Site | Karlstad | 651 85 | Sweden |
| Novo Nordisk Investigational Site | Karlstad | 652 24 | Sweden |
| Novo Nordisk Investigational Site | Kristianstad | 291 38 | Sweden |
| Novo Nordisk Investigational Site | Kristinehamn | 681 80 | Sweden |
| Novo Nordisk Investigational Site | Kungsbacka | 434 80 | Sweden |
| Novo Nordisk Investigational Site | Malmö | 205 02 | Sweden |
| Novo Nordisk Investigational Site | Mellerud | 464 30 | Sweden |
| Novo Nordisk Investigational Site | Mölndal | 431 80 | Sweden |
| Novo Nordisk Investigational Site | Norrköping | 602 36 | Sweden |
| Novo Nordisk Investigational Site | Örebro | 701 85 | Sweden |
| Novo Nordisk Investigational Site | Örebro | 702 15 | Sweden |
| Novo Nordisk Investigational Site | Örebro | 703 51 | Sweden |
| Novo Nordisk Investigational Site | Östersund | 831 62 | Sweden |
| Novo Nordisk Investigational Site | Östersund | 831 83 | Sweden |
| Novo Nordisk Investigational Site | Säffle | 661 81 | Sweden |
| Novo Nordisk Investigational Site | Skövde | 541 85 | Sweden |
| Novo Nordisk Investigational Site | Stockholm | 116 91 | Sweden |
| Novo Nordisk Investigational Site | Tomelilla | 273 34 | Sweden |
| Novo Nordisk Investigational Site | Torsby | 685 29 | Sweden |
| Novo Nordisk Investigational Site | Trollhättan | 461 40 | Sweden |
| Novo Nordisk Investigational Site | Trollhättan | 461 85 | Sweden |
| Novo Nordisk Investigational Site | Tyresö | 135 21 | Sweden |
| Novo Nordisk Investigational Site | Uddevalla | 451 80 | Sweden |
| Novo Nordisk Investigational Site | Värnamo | 331 85 | Sweden |
| 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 |
| C575870 | biphasic human insulin 30 |
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