Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Multinational, Randomised, Open-labelled, Parallel Group Four Months Comparison of Twice Daily Biphasic Human Insulin 30 and Thrice Daily Biphasic Insulin Aspart 50 and 70 in Subjects With Type 1 or Type 2 Diabetes
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.
| Status | Completed |
| Enrollment | 666 |
| Est. completion date | April 2001 |
| Est. primary completion date | April 2001 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Type 1 or Type 2 diabetes - Current treatment with BHI 30 twice daily as the only insulin therapy for at least 3 months, with or without combination with oral hypoglycaemic agents - Body mass index (BMI) maximum 40.0 kg/m^2 Exclusion Criteria: - History of drug or alcohol dependence - Impaired hepatic function - Impaired renal function - Cardiac disease - Proliferative retinopathy - Total daily insulin dose at least 1.80 IU/kg |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Novo Nordisk Investigational Site | Aalst | |
| Belgium | Novo Nordisk Investigational Site | Brussels | |
| Belgium | Novo Nordisk Investigational Site | Brussels | |
| Belgium | Novo Nordisk Investigational Site | Edegem | |
| Belgium | Novo Nordisk Investigational Site | Genk | |
| Belgium | Novo Nordisk Investigational Site | Jumet | |
| Belgium | Novo Nordisk Investigational Site | Liège | |
| France | Novo Nordisk Investigational Site | Amiens | |
| France | Novo Nordisk Investigational Site | Avignon | |
| France | Novo Nordisk Investigational Site | Bagnols-sur-ceze | |
| France | Novo Nordisk Investigational Site | Bordeaux | |
| France | Novo Nordisk Investigational Site | Caen | |
| France | Novo Nordisk Investigational Site | Colmar | |
| France | Novo Nordisk Investigational Site | DIJON cedex | |
| France | Novo Nordisk Investigational Site | Dommartin Les Toul | |
| France | Novo Nordisk Investigational Site | GRENOBLE cedex | |
| France | Novo Nordisk Investigational Site | LA ROCHELLE cedex | |
| France | Novo Nordisk Investigational Site | Le Creusot | |
| France | Novo Nordisk Investigational Site | Lorient | |
| France | Novo Nordisk Investigational Site | Lyon | |
| France | Novo Nordisk Investigational Site | Macon | |
| France | Novo Nordisk Investigational Site | Marseille | |
| France | Novo Nordisk Investigational Site | Nanterre | |
| France | Novo Nordisk Investigational Site | Narbonne | |
| France | Novo Nordisk Investigational Site | NEVERS cedex | |
| France | Novo Nordisk Investigational Site | Nimes | |
| France | Novo Nordisk Investigational Site | Orleans | |
| France | Novo Nordisk Investigational Site | Paris | |
| France | Novo Nordisk Investigational Site | Paris | |
| France | Novo Nordisk Investigational Site | Reims | |
| France | Novo Nordisk Investigational Site | Roubaix | |
| France | Novo Nordisk Investigational Site | Saint Etienne | |
| France | Novo Nordisk Investigational Site | Strasbourg | |
| France | Novo Nordisk Investigational Site | TOULOUSE cedex | |
| Ireland | Novo Nordisk Investigational Site | Dublin | |
| Ireland | Novo Nordisk Investigational Site | Dublin | |
| Ireland | Novo Nordisk Investigational Site | Dublin | |
| Netherlands | Novo Nordisk Investigational Site | Alkmaar | |
| Netherlands | Novo Nordisk Investigational Site | Amersfoort | |
| Netherlands | Novo Nordisk Investigational Site | Arnhem | |
| Netherlands | Novo Nordisk Investigational Site | Beverwijk | |
| Netherlands | Novo Nordisk Investigational Site | Delft | |
| Netherlands | Novo Nordisk Investigational Site | Den Bosch | |
| Netherlands | Novo Nordisk Investigational Site | Den Haag | |
| Netherlands | Novo Nordisk Investigational Site | Einhoven | |
| Netherlands | Novo Nordisk Investigational Site | Hengelo | |
| Netherlands | Novo Nordisk Investigational Site | Rotterdam | |
| Netherlands | Novo Nordisk Investigational Site | Rotterdam | |
| United Kingdom | Novo Nordisk Investigational Site | Ayr | |
| United Kingdom | Novo Nordisk Investigational Site | Ayrsh | |
| United Kingdom | Novo Nordisk Investigational Site | Bath | |
| United Kingdom | Novo Nordisk Investigational Site | Birmingham | |
| United Kingdom | Novo Nordisk Investigational Site | Brighton | |
| United Kingdom | Novo Nordisk Investigational Site | Coventry | |
| United Kingdom | Novo Nordisk Investigational Site | Dundee | |
| United Kingdom | Novo Nordisk Investigational Site | Edgware | |
| United Kingdom | Novo Nordisk Investigational Site | Edinburgh | |
| United Kingdom | Novo Nordisk Investigational Site | Exeter | |
| United Kingdom | Novo Nordisk Investigational Site | Glasgow | |
| United Kingdom | Novo Nordisk Investigational Site | Haywards Heath | |
| United Kingdom | Novo Nordisk Investigational Site | Ipswich | |
| United Kingdom | Novo Nordisk Investigational Site | Leeds | |
| United Kingdom | Novo Nordisk Investigational Site | Leicester | |
| United Kingdom | Novo Nordisk Investigational Site | London | |
| United Kingdom | Novo Nordisk Investigational Site | London | |
| United Kingdom | Novo Nordisk Investigational Site | Manchester | |
| United Kingdom | Novo Nordisk Investigational Site | Manchester | |
| United Kingdom | Novo Nordisk Investigational Site | Nottingham | |
| United Kingdom | Novo Nordisk Investigational Site | Paisley | |
| United Kingdom | Novo Nordisk Investigational Site | Poole | |
| United Kingdom | Novo Nordisk Investigational Site | Rugby | |
| United Kingdom | Novo Nordisk Investigational Site | Scunthorpe | |
| United Kingdom | Novo Nordisk Investigational Site | Southampton | |
| United Kingdom | Novo Nordisk Investigational Site | Sunderland | |
| United Kingdom | Novo Nordisk Investigational Site | Swansea | |
| United Kingdom | Novo Nordisk Investigational Site | Watford | |
| United Kingdom | Novo Nordisk Investigational Site | Whiston |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Belgium, France, Ireland, Netherlands, United Kingdom,
Clements MR, Tits J, Kinsley BT, Råstam 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 diabe — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c (glycosylated haemoglobin A1c) | No | ||
| Secondary | Blood glucose profiles | No | ||
| Secondary | Adverse events | No | ||
| Secondary | Hypoglycaemic episodes | No | ||
| Secondary | Quality of Life (QoL) assessed via World Health Organization Diabetes Treatment Satisfaction Questionnaire (WHO DTSQ) | No | ||
| Secondary | Quality of Life (QoL) assessed via Diabetes Health Profile (DHP-2) | No |
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