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This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment period 1 | Experimental |
| |
| Treatment period 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 30 | Drug | Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose average in 24-hour blood glucose profiles |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-meal glucose level | ||
| Post-meal excursion of glucose (0-4 hours) | ||
| Cmax, maximum concentration of total insulin |
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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 | Newcastle | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19527481 | Result | Dashora U, Ashwell SG, Home PD. An exploratory study of the effect of using high-mix biphasic insulin aspart in people with type 2 diabetes. Diabetes Obes Metab. 2009 Jul;11(7):680-7. doi: 10.1111/j.1463-1326.2008.01024.x. |
| 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 |
| C575870 | biphasic human insulin 30 |
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| biphasic insulin aspart 70 | Drug | Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period |
|
| biphasic human insulin 30 | Drug | Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period |
|
| tmax, time of maximum concentration of total insulin |
| The area under the 24-hour total insulin concentration time curve |
| Adverse events |