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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 (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIAsp 50 or 70 | Experimental |
| |
| BHI 30 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biphasic insulin aspart 50 | Drug | Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being obese with a body mass index (BMI) exceeding 30 kg/m^2 will receive BIAsp 50 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (glycosylated haemoglobin A1c) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose profiles | ||
| Adverse events | ||
| Hypoglycaemic episodes |
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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 | Aalst | 9300 | Belgium | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18269638 | Result | Clements MR, Tits J, Kinsley BT, Rastam J, Friberg HH, Ligthelm RJ. Improved glycaemic control of thrice-daily biphasic insulin aspart compared with twice-daily biphasic human insulin; a randomized, open-label trial in patients with type 1 or type 2 diabetes. Diabetes Obes Metab. 2008 Mar;10(3):229-37. doi: 10.1111/j.1463-1326.2006.00687.x. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| biphasic insulin aspart 70 | Drug | Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being lean and overweight with a body mass index (BMI) of maximum 30 kg/m^2 will receive BIAsp 70 |
|
| biphasic human insulin 30 | Drug | Administered subcutaneously (s.c., under the skin), twice a day |
|
| Quality of Life (QoL) assessed via World Health Organization Diabetes Treatment Satisfaction Questionnaire (WHO DTSQ) |
| Quality of Life (QoL) assessed via Diabetes Health Profile (DHP-2) |
| Brussels |
| 1020 |
| Belgium |
| Novo Nordisk Investigational Site | Brussels | 1090 | Belgium |
| Novo Nordisk Investigational Site | Edegem | 2650 | Belgium |
| Novo Nordisk Investigational Site | Genk | 3600 | Belgium |
| Novo Nordisk Investigational Site | Jumet | 6040 | Belgium |
| Novo Nordisk Investigational Site | Liège | 4000 | Belgium |
| Novo Nordisk Investigational Site | Amiens | France |
| Novo Nordisk Investigational Site | Avignon | 84902 | France |
| Novo Nordisk Investigational Site | Bagnols-sur-Cèze | 30200 | France |
| Novo Nordisk Investigational Site | Bordeaux | 33076 | France |
| Novo Nordisk Investigational Site | Caen | 14033 | France |
| Novo Nordisk Investigational Site | Colmar | 68024 | France |
| Novo Nordisk Investigational Site | Dijon | 21079 | France |
| Novo Nordisk Investigational Site | Dommartin-lès-Toul | 54201 | France |
| Novo Nordisk Investigational Site | Grenoble | 38043 | France |
| Novo Nordisk Investigational Site | La Rochelle | 17019 | France |
| Novo Nordisk Investigational Site | Le Creusot | 71200 | France |
| Novo Nordisk Investigational Site | Lorient | 56322 | France |
| Novo Nordisk Investigational Site | Lyon | 69437 | France |
| Novo Nordisk Investigational Site | Marseille | 13009 | France |
| Novo Nordisk Investigational Site | Mâcon | 71000 | France |
| Novo Nordisk Investigational Site | Nanterre | 92014 | France |
| Novo Nordisk Investigational Site | Narbonne | 11108 | France |
| Novo Nordisk Investigational Site | Nevers | 58033 | France |
| Novo Nordisk Investigational Site | Nîmes | 30006 | France |
| Novo Nordisk Investigational Site | Orléans | France |
| Novo Nordisk Investigational Site | Paris | 75007 | France |
| Novo Nordisk Investigational Site | Paris | 75014 | France |
| Novo Nordisk Investigational Site | Reims | 51056 | France |
| Novo Nordisk Investigational Site | Roubaix | 59056 | France |
| Novo Nordisk Investigational Site | Saint-Etienne | France |
| Novo Nordisk Investigational Site | Strasbourg | 67091 | France |
| Novo Nordisk Investigational Site | Toulouse | 31054 | France |
| Novo Nordisk Investigational Site | Dublin | DUBLIN 15 | Ireland |
| Novo Nordisk Investigational Site | Dublin | DUBLIN 7 | Ireland |
| Novo Nordisk Investigational Site | Dublin | Ireland |
| Novo Nordisk Investigational Site | 's-Hertogenbosch | 5223 GV | Netherlands |
| Novo Nordisk Investigational Site | Alkmaar | 1815 JD | Netherlands |
| Novo Nordisk Investigational Site | Amersfoort | 3816 CP | Netherlands |
| Novo Nordisk Investigational Site | Arnhem | Netherlands |
| Novo Nordisk Investigational Site | Beverwijk | Netherlands |
| Novo Nordisk Investigational Site | Delft | 2625 AD | Netherlands |
| Novo Nordisk Investigational Site | Einhoven | Netherlands |
| Novo Nordisk Investigational Site | Hengelo | 7555 DL | Netherlands |
| Novo Nordisk Investigational Site | Rotterdam | 3011 TD | Netherlands |
| Novo Nordisk Investigational Site | Rotterdam | 3021 HC | Netherlands |
| Novo Nordisk Investigational Site | The Hague | 2597 AX | Netherlands |
| Novo Nordisk Investigational Site | Ayr | KA6 6DX | United Kingdom |
| Novo Nordisk Investigational Site | Ayrsh | KA2 0BE | United Kingdom |
| Novo Nordisk Investigational Site | Bath | BA1 3NG | United Kingdom |
| Novo Nordisk Investigational Site | Birmingham | B9 5SS | United Kingdom |
| Novo Nordisk Investigational Site | Brighton | BN2 5BE | United Kingdom |
| Novo Nordisk Investigational Site | Coventry | CV1 4FH | United Kingdom |
| Novo Nordisk Investigational Site | Dundee | DD1 9SY | United Kingdom |
| Novo Nordisk Investigational Site | Edgware | HA8 0AD | United Kingdom |
| Novo Nordisk Investigational Site | Edinburgh | EH4 2XU | United Kingdom |
| Novo Nordisk Investigational Site | Exeter | EX2 5AX | United Kingdom |
| Novo Nordisk Investigational Site | Glasgow | G51 4TF | United Kingdom |
| Novo Nordisk Investigational Site | Haywards Heath | RH16 4EX | United Kingdom |
| Novo Nordisk Investigational Site | Ipswich | IP4 5PD | United Kingdom |
| Novo Nordisk Investigational Site | Leeds | LS9 7TF | United Kingdom |
| Novo Nordisk Investigational Site | Leicester | LE1 5WW | United Kingdom |
| Novo Nordisk Investigational Site | London | E11 1NR | United Kingdom |
| Novo Nordisk Investigational Site | London | N19 3UA | United Kingdom |
| Novo Nordisk Investigational Site | Manchester | M13 0JE | United Kingdom |
| Novo Nordisk Investigational Site | Manchester | M8 5RB | United Kingdom |
| Novo Nordisk Investigational Site | Nottingham | NG7 2UH | United Kingdom |
| Novo Nordisk Investigational Site | Paisley | PA2 9PL | United Kingdom |
| Novo Nordisk Investigational Site | Poole | BH15 2JB | United Kingdom |
| Novo Nordisk Investigational Site | Rugby | CV22 5PX | United Kingdom |
| Novo Nordisk Investigational Site | Scunthorpe | DN15 7BH | United Kingdom |
| Novo Nordisk Investigational Site | Southampton | SO14 OYG | United Kingdom |
| Novo Nordisk Investigational Site | Sunderland | SR4 7TP | United Kingdom |
| Novo Nordisk Investigational Site | Swansea | SA6 6NL | 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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