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This trial was conducted in Russian Federation. This trial aimed for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different treatment regimens: biphasic insulin aspart 30 thrice daily, biphasic insulin aspart 30 twice daily in combination with metformin and treatment with oral anti-diabetic drugs.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | after 16 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Self-measured 7-point capillary plasma glucose profile | ||
| Change in body weight | ||
| Incidence of hypoglycaemic episodes and 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 | Arkhangelsk | 163045 | Russia | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18158078 | Result | Ushakova O, Sokolovskaya V, Morozova A, Valeeva F, Zanozina O, Sazonova O, Zhadanova E, Starceva M, Kazakova E, Saifullina M, Shapiro I, Tarasov A, Al-Tayar B, Starkova N. Comparison of biphasic insulin aspart 30 given three times daily or twice daily in combination with metformin versus oral antidiabetic drugs alone in patients with poorly controlled type 2 diabetes: a 16-week, randomized, open-label, parallel-group trial conducted in russia. Clin Ther. 2007 Nov;29(11):2374-84. doi: 10.1016/j.clinthera.2007.11.017. |
| 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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| Quality of Life |
| Belgorod |
| 308007 |
| Russia |
| Novo Nordisk Investigational Site | Kazan' | 420064 | Russia |
| Novo Nordisk Investigational Site | Khabarovsk | 680067 | Russia |
| Novo Nordisk Investigational Site | Nizhny Novgorod | 603126 | Russia |
| Novo Nordisk Investigational Site | Novosibirsk | 630090 | Russia |
| Novo Nordisk Investigational Site | Omsk | 644070 | Russia |
| Novo Nordisk Investigational Site | Saint Petersburg | 194291 | Russia |
| Novo Nordisk Investigational Site | Vladivostok | 690105 | Russia |
| Novo Nordisk Investigational Site | Voronezh | 394053 | Russia |
| Novo Nordisk Investigational Site | Yekaterinburg | 620102 | Russia |