Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes
NCT ID: NCT01520818
Last Updated: 2017-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
666 participants
INTERVENTIONAL
2000-03-31
2001-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BIAsp 50 or 70
biphasic insulin aspart 50
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
biphasic insulin aspart 70
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
BHI 30
biphasic human insulin 30
Administered subcutaneously (s.c., under the skin), twice a day
Interventions
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biphasic insulin aspart 50
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
biphasic insulin aspart 70
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
Administered subcutaneously (s.c., under the skin), twice a day
Eligibility Criteria
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Inclusion Criteria
* 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
* Impaired hepatic function
* Impaired renal function
* Cardiac disease
* Proliferative retinopathy
* Total daily insulin dose at least 1.80 IU/kg
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR,1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Aalst, , Belgium
Novo Nordisk Investigational Site
Brussels, , Belgium
Novo Nordisk Investigational Site
Brussels, , Belgium
Novo Nordisk Investigational Site
Edegem, , Belgium
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Genk, , Belgium
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Jumet, , Belgium
Novo Nordisk Investigational Site
Liège, , Belgium
Novo Nordisk Investigational Site
Amiens, , France
Novo Nordisk Investigational Site
Avignon, , France
Novo Nordisk Investigational Site
Bagnols-sur-Cèze, , France
Novo Nordisk Investigational Site
Bordeaux, , France
Novo Nordisk Investigational Site
Caen, , France
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Colmar, , France
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Dijon, , France
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Dommartin-lès-Toul, , France
Novo Nordisk Investigational Site
Grenoble, , France
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La Rochelle, , France
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Le Creusot, , France
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Lorient, , France
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Lyon, , France
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Marseille, , France
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Mâcon, , France
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Nanterre, , France
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Narbonne, , France
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Nevers, , France
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Nîmes, , France
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Orléans, , France
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Paris, , France
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Paris, , France
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Reims, , France
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Roubaix, , France
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Saint-Etienne, , France
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Strasbourg, , France
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Toulouse, , France
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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's-Hertogenbosch, , Netherlands
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Alkmaar, , Netherlands
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Amersfoort, , Netherlands
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Arnhem, , Netherlands
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Beverwijk, , Netherlands
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Delft, , Netherlands
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Einhoven, , Netherlands
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Hengelo, , Netherlands
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Rotterdam, , Netherlands
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Rotterdam, , Netherlands
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The Hague, , Netherlands
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Ayr, , United Kingdom
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Ayrsh, , United Kingdom
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Bath, , United Kingdom
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Birmingham, , United Kingdom
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Brighton, , United Kingdom
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Coventry, , United Kingdom
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Dundee, , United Kingdom
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Edgware, , United Kingdom
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Edinburgh, , United Kingdom
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Exeter, , United Kingdom
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Glasgow, , United Kingdom
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Haywards Heath, , United Kingdom
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Ipswich, , United Kingdom
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Leeds, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Manchester, , United Kingdom
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Nottingham, , United Kingdom
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Paisley, , United Kingdom
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Poole, , United Kingdom
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Rugby, , United Kingdom
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Scunthorpe, , United Kingdom
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Southampton, , United Kingdom
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Sunderland, , United Kingdom
Novo Nordisk Investigational Site
Swansea, , United Kingdom
Novo Nordisk Investigational Site
Watford, , United Kingdom
Novo Nordisk Investigational Site
Whiston, , United Kingdom
Countries
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References
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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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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BIASP-1075
Identifier Type: -
Identifier Source: org_study_id
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