Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes
NCT ID: NCT01467323
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
303 participants
INTERVENTIONAL
1998-04-30
1998-09-30
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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A
biphasic insulin aspart
Injected subcutaneously (under the skin) twice daily
B
biphasic human insulin
Injected subcutaneously (under the skin) twice daily
Interventions
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biphasic insulin aspart
Injected subcutaneously (under the skin) twice daily
biphasic human insulin
Injected subcutaneously (under the skin) twice daily
Eligibility Criteria
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Inclusion Criteria
* Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months
* Body mass index (BMI) below or equal to 35.0 kg/m\^2
* HbA1c below or equal to 11.0%
Exclusion Criteria
* Treatment with oral hypoglycaemic agents within the month prior to inclusion
* Recurrent severe hypoglycaemia (as judged by the investigator)
* Active proliferative retinopathy
* Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)
* History of pancreatitis
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
Graz, , Austria
Novo Nordisk Investigational Site
Vienna, , Austria
Novo Nordisk Investigational Site
Anklam, , Germany
Novo Nordisk Investigational Site
Berlin, , Germany
Novo Nordisk Investigational Site
Berlin, , Germany
Novo Nordisk Investigational Site
Cottbus, , Germany
Novo Nordisk Investigational Site
Erkner, , Germany
Novo Nordisk Investigational Site
Hamburg, , Germany
Novo Nordisk Investigational Site
Jena, , Germany
Novo Nordisk Investigational Site
Leipzig, , Germany
Novo Nordisk Investigational Site
München, , Germany
Novo Nordisk Investigational Site
Neunkirchen, , Germany
Novo Nordisk Investigational Site
Quakenbrück, , Germany
Novo Nordisk Investigational Site
Rostock, , Germany
Novo Nordisk Investigational Site
Saarlouis, , Germany
Novo Nordisk Investigational Site
Schwedt, , Germany
Novo Nordisk Investigational Site
Ulm, , Germany
Novo Nordisk Investigational Site
Würzburg, , Germany
Novo Nordisk Investigational Site
Cork, , Ireland
Novo Nordisk Investigational Site
Dublin, , Ireland
Novo Nordisk Investigational Site
Dublin, , Ireland
Novo Nordisk Investigational Site
Bern, , Switzerland
Novo Nordisk Investigational Site
Ayr, , United Kingdom
Novo Nordisk Investigational Site
Bath, , United Kingdom
Novo Nordisk Investigational Site
Birmingham, , United Kingdom
Novo Nordisk Investigational Site
Blackburn, , United Kingdom
Novo Nordisk Investigational Site
Bolton, , United Kingdom
Novo Nordisk Investigational Site
Bristol, , United Kingdom
Novo Nordisk Investigational Site
Kettering, , United Kingdom
Novo Nordisk Investigational Site
Leicester, , United Kingdom
Novo Nordisk Investigational Site
Livingstone, , United Kingdom
Novo Nordisk Investigational Site
Newcastle, , United Kingdom
Novo Nordisk Investigational Site
Northampton, , United Kingdom
Novo Nordisk Investigational Site
Nottingham, , United Kingdom
Novo Nordisk Investigational Site
Paisley, , 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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Boehm BO, Home PD, Behrend C, Kamp NM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in Type 1 and Type 2 diabetic patients. Diabet Med. 2002 May;19(5):393-9. doi: 10.1046/j.1464-5491.2002.00733.x.
Lindholm A, Jensen LB, Home PD, Raskin P, Boehm BO, Rastam J. Immune responses to insulin aspart and biphasic insulin aspart in people with type 1 and type 2 diabetes. Diabetes Care. 2002 May;25(5):876-82. doi: 10.2337/diacare.25.5.876.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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ANA/DCD/038
Identifier Type: -
Identifier Source: org_study_id
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