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This trial is conducted in Europe. The aim of this trial is to investigate the difference in frequency of episodes of hypoglycaemia during treatment with biphasic insulin aspart 30 compared to biphasic human insulin 30 in subjects with well controlled 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 human insulin 30 | Drug | Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of hypoglycaemic episodes |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of reported severe hypoglycaemic episodes | ||
| Overall frequency of nocturnal hypoglycaemia | ||
| HbA1c (glycosylated haemoglobin A1c) |
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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 | Bolton | BL1 4QS | United Kingdom | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17277042 | Result | McNally PG, Dean JD, Morris AD, Wilkinson PD, Compion G, Heller SR. Using continuous glucose monitoring to measure the frequency of low glucose values when using biphasic insulin aspart 30 compared with biphasic human insulin 30: a double-blind crossover study in individuals with type 2 diabetes. Diabetes Care. 2007 May;30(5):1044-8. doi: 10.2337/dc06-1328. Epub 2007 Feb 2. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| biphasic insulin aspart 30 | Drug | Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2 |
|
| Diabetes Treatment Satisfaction Questionaire |
| Cardiff |
| CF14 4XW |
| United Kingdom |
| Novo Nordisk Investigational Site | Derby | DE7 1DY | United Kingdom |
| Novo Nordisk Investigational Site | Dundee | DD1 9SY | United Kingdom |
| Novo Nordisk Investigational Site | Exeter | EX2 5AX | United Kingdom |
| Novo Nordisk Investigational Site | Galway | EIRE | United Kingdom |
| Novo Nordisk Investigational Site | Glasgow | G4 0SF | United Kingdom |
| Novo Nordisk Investigational Site | Leicester | LE1 5WW | United Kingdom |
| Novo Nordisk Investigational Site | Liverpool | L7 8XP | United Kingdom |
| Novo Nordisk Investigational Site | London | NW10 7NS | United Kingdom |
| Novo Nordisk Investigational Site | London | SE1 7EH | United Kingdom |
| Novo Nordisk Investigational Site | Newcastle | NE7 7DN | United Kingdom |
| Novo Nordisk Investigational Site | Nottingham | NG7 2UH | United Kingdom |
| Novo Nordisk Investigational Site | Sheffield | S5 7AU | United Kingdom |
| Novo Nordisk Investigational Site | Upton | L49 5PE | United Kingdom |
| Novo Nordisk Investigational Site | Wirral, Merseyside | CH63 4JY | United Kingdom |
| Novo Nordisk Investigational Site | York | YO3 7HE | United Kingdom |
| 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 |
|---|---|
| C575870 | biphasic human insulin 30 |
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
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