Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes
NCT ID: NCT00600626
Last Updated: 2017-01-06
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
394 participants
INTERVENTIONAL
2004-01-31
2004-07-31
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
Interventions
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biphasic insulin aspart
insulin NPH
insulin aspart
Eligibility Criteria
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Inclusion Criteria
* Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs
* HbA1c between 8.0-10.5%
* Body mass index (BMI) below 35.0 kg/m2
* Able and willing to perform self-monitoring of blood glucose
Exclusion Criteria
* Known or suspected allergy to trial product or related products
* Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures
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
Zagreb, , Croatia
Novo Nordisk Investigational Site
Lille, , France
Novo Nordisk Investigational Site
Nevers, , France
Novo Nordisk Investigational Site
Rennes, , France
Novo Nordisk Investigational Site
Vénissieux, , France
Novo Nordisk Investigational Site
Bad Heilbrunn, , Germany
Novo Nordisk Investigational Site
Neuss, , Germany
Novo Nordisk Investigational Site
Saint Ingbert, , Germany
Novo Nordisk Investigational Site
Schaafheim, , Germany
Novo Nordisk Investigational Site
Schwedt, , Germany
Novo Nordisk Investigational Site
Völklingen, , Germany
Novo Nordisk Investigational Site
Wiesbaden, , Germany
Novo Nordisk Investigational Site
Würzburg, , Germany
Novo Nordisk Investigational Site
Shatin, New Territories, , Hong Kong
Novo Nordisk Investigational Site
Cheras, , Malaysia
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, , Malaysia
Novo Nordisk Investigational Site
Beverwijk, , Netherlands
Novo Nordisk Investigational Site
Delft, , Netherlands
Novo Nordisk Investigational Site
Eindhoven, , Netherlands
Novo Nordisk Investigational Site
Rotterdam, , Netherlands
Novo Nordisk Investigational Site
Lodz, , Poland
Novo Nordisk Investigational Site
Lublin, , Poland
Novo Nordisk Investigational Site
Szczecin, , Poland
Novo Nordisk Investigational Site
Warsaw, , Poland
Novo Nordisk Investigational Site
Zabrze, , Poland
Novo Nordisk Investigational Site
Cluj-Napoca, Cluj, Romania
Novo Nordisk Investigational Site
Constanța, , Romania
Novo Nordisk Investigational Site
Iași, , Romania
Novo Nordisk Investigational Site
Timișoara, , Romania
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Saint Petersburg, , Russia
Novo Nordisk Investigational Site
Saint Petersburg, , Russia
Novo Nordisk Investigational Site
Singapore, , Singapore
Novo Nordisk Investigational Site
Córdoba, , Spain
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Orihuela, , Spain
Novo Nordisk Investigational Site
Sabadell, , Spain
Novo Nordisk Investigational Site
Seville, , Spain
Novo Nordisk Investigational Site
Seville, , Spain
Novo Nordisk Investigational Site
Valladolid, , Spain
Novo Nordisk Investigational Site
Falun, , Sweden
Novo Nordisk Investigational Site
Gothenburg, , Sweden
Novo Nordisk Investigational Site
Linköping, , Sweden
Novo Nordisk Investigational Site
Lund, , Sweden
Novo Nordisk Investigational Site
Mölndal, , Sweden
Novo Nordisk Investigational Site
Uppsala, , Sweden
Novo Nordisk Investigational Site
Bradford, , United Kingdom
Novo Nordisk Investigational Site
Brighton, , United Kingdom
Novo Nordisk Investigational Site
Coventry, , United Kingdom
Novo Nordisk Investigational Site
Edinburgh, , United Kingdom
Novo Nordisk Investigational Site
Glasgow, , United Kingdom
Novo Nordisk Investigational Site
Northampton, , United Kingdom
Novo Nordisk Investigational Site
Plymouth, , United Kingdom
Novo Nordisk Investigational Site
York, , United Kingdom
Countries
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References
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Ligthelm RJ, Mouritzen U, Lynggaard H, Landin-Olsson M, Fox C, le Devehat C, Romero E, Liebl A. Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections: a randomised open-label parallel group four months comparison in patients with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Oct;114(9):511-9. doi: 10.1055/s-2006-924424.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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BIASP-1486
Identifier Type: -
Identifier Source: org_study_id
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