Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes
NCT ID: NCT00619697
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
PHASE4
260 participants
INTERVENTIONAL
2003-12-31
2005-03-31
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 glargine
metformin
glimepiride
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Insulin naive. Short term insulin treatment (7 days or less within the last 6 months) is allowed
* Previous treatment with oral antidiabetic drugs for at least 4 months
* Judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen
* BMI below 40 kg/m2
* HbA1c between 7-12%
* Able and willing to perform self-plasma glucose monitoring
Exclusion Criteria
* A history of drug or alcohol abuse within the last 12 months
* Severe, uncontrolled hypertension
* Known or suspected allergy to trial products or related products
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
Ebreichsdorf, , Austria
Novo Nordisk Investigational Site
Feldkirch, , Austria
Novo Nordisk Investigational Site
Graz, , Austria
Novo Nordisk Investigational Site
Horn, , Austria
Novo Nordisk Investigational Site
Oberpullendorf, , Austria
Novo Nordisk Investigational Site
Salzburg, , Austria
Novo Nordisk Investigational Site
Villach, , Austria
Novo Nordisk Investigational Site
Waidhofen A.d. Thaya, , Austria
Novo Nordisk Investigational Site
Brno, , Czechia
Novo Nordisk Investigational Site
Liberec, , Czechia
Novo Nordisk Investigational Site
Augsburg, , Germany
Novo Nordisk Investigational Site
Castrop-Rauxel, , Germany
Novo Nordisk Investigational Site
Deggingen, , Germany
Novo Nordisk Investigational Site
Duisburg, , Germany
Novo Nordisk Investigational Site
Erlangen, , Germany
Novo Nordisk Investigational Site
Eschweiler, , Germany
Novo Nordisk Investigational Site
Friedrichsthal, , Germany
Novo Nordisk Investigational Site
Fulda, , Germany
Novo Nordisk Investigational Site
Hamburg, , Germany
Novo Nordisk Investigational Site
Hamburg, , Germany
Novo Nordisk Investigational Site
Herne, , Germany
Novo Nordisk Investigational Site
Kippenheim, , Germany
Novo Nordisk Investigational Site
Lauffen am Neckar, , Germany
Novo Nordisk Investigational Site
Leverkusen, , Germany
Novo Nordisk Investigational Site
Ludwigsburg, , Germany
Novo Nordisk Investigational Site
Ludwigshafen, , Germany
Novo Nordisk Investigational Site
Ludwigshafen, , Germany
Novo Nordisk Investigational Site
Mannheim, , Germany
Novo Nordisk Investigational Site
Mannheim, , Germany
Novo Nordisk Investigational Site
Marburg, , Germany
Novo Nordisk Investigational Site
Marburg, , Germany
Novo Nordisk Investigational Site
Mülheim, , Germany
Novo Nordisk Investigational Site
Neunkirchen, , Germany
Novo Nordisk Investigational Site
Ostercappeln, , Germany
Novo Nordisk Investigational Site
Pritzwalk, , Germany
Novo Nordisk Investigational Site
Rosenheim, , Germany
Novo Nordisk Investigational Site
Viernheim, , Germany
Novo Nordisk Investigational Site
Weil der Stadt, , Germany
Novo Nordisk Investigational Site
Weiskirchen, , Germany
Novo Nordisk Investigational Site
Witten, , Germany
Novo Nordisk Investigational Site
Witten, , Germany
Novo Nordisk Investigational Site
Budapest, , Hungary
Novo Nordisk Investigational Site
Eger, , Hungary
Novo Nordisk Investigational Site
Szekszárd, , Hungary
Novo Nordisk Investigational Site
Częstochowa, , Poland
Novo Nordisk Investigational Site
Gdynia, , Poland
Novo Nordisk Investigational Site
Lublin, , Poland
Novo Nordisk Investigational Site
Otwock, , Poland
Novo Nordisk Investigational Site
Poznan, , Poland
Novo Nordisk Investigational Site
L'ubochna, , Slovakia
Novo Nordisk Investigational Site
Martin, , Slovakia
Novo Nordisk Investigational Site
Celje, , Slovenia
Novo Nordisk Investigational Site
Ljubljana, , Slovenia
Novo Nordisk Investigational Site
Maribor, , Slovenia
Countries
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References
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Kann PH, Wascher T, Zackova V, Moeller J, Medding J, Szocs A, Mokan M, Mrevlje F, Regulski M. Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin Aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride. Exp Clin Endocrinol Diabetes. 2006 Oct;114(9):527-32. doi: 10.1055/s-2006-949655.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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BIASP-1564
Identifier Type: -
Identifier Source: org_study_id
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