Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes
NCT ID: NCT00605020
Last Updated: 2017-06-27
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
719 participants
INTERVENTIONAL
2003-12-02
2005-03-03
Brief Summary
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The aim of this trial is to investigate the efficacy and safety of an intensified treatment regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in subjects with type 2 diabetes.
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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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insulin detemir
insulin aspart
biphasic insulin aspart
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Duration of type 2 diabetes for at least 6 months since diagnosis
* Current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily
* BMI below 40 kg/m2
* HbA1c between 7-12%
* Able and willing to perform self-monitoring of capillary blood glucose
Exclusion Criteria
* Previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed)
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
* Known or suspected allergy to trial product or related products
* Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
* Receipt of any investigational drug within 4 weeks prior to this trial
* Previous participation in this trial
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
Linz, , Austria
Novo Nordisk Investigational Site
Vienna, , Austria
Novo Nordisk Investigational Site
Vienna, , Austria
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Vienna, , Austria
Novo Nordisk Investigational Site
Alsdorf, , Germany
Novo Nordisk Investigational Site
Altenburg, , Germany
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Altenkirchen, , Germany
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Altenstadt, , Germany
Novo Nordisk Investigational Site
Aschaffenburg, , Germany
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Augsburg, , Germany
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Bad Harzburg, , Germany
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Bad Heilbrunn, , Germany
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Bad Kreuznach, , Germany
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Bad Lauterberg im Harz, , Germany
Novo Nordisk Investigational Site
Bad Lippspringe, , Germany
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Bad Mergentheim, , Germany
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Bad Neuenahr-Ahrweiler, , Germany
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Bad Oldesloe, , Germany
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Bad Staffelstein, , Germany
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Bensheim, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bochum, , Germany
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Damme, , Germany
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Diez, , Germany
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Dinslaken, , Germany
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Dormagen, , Germany
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Dortmund, , Germany
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Dortmund, , Germany
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Dresden, , Germany
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Dresden, , Germany
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Duisburg, , Germany
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Duisburg, , Germany
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Emmerich, , Germany
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Essen, , Germany
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Essen, , Germany
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Flensburg, , Germany
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Flörsheim, , Germany
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Forchheim, , Germany
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Frankfurt, , Germany
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Frankfurt, , Germany
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Frankfurt, , Germany
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Freital, , Germany
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Gebhardshain, , Germany
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Genthin, , Germany
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Georgsmarienhütte, , Germany
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Giessen, , Germany
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Gotha, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamelin, , Germany
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Hanover, , Germany
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Herne, , Germany
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Herrenberg, , Germany
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Hildesheim, , Germany
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Hohenmölsen, , Germany
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Hünxe, , Germany
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Idar-Oberstein, , Germany
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Jena, , Germany
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Kaiserslautern, , Germany
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Karlsruhe, , Germany
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Krummennaab, , Germany
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Künzing, , Germany
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Landau, , Germany
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Langen, , Germany
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Lindenfels, , Germany
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Lübeck, , Germany
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Mainz, , Germany
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Marburg, , Germany
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Marktheidenfeld, , Germany
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Meppen, , Germany
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Mühlheim, , Germany
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München, , Germany
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Neumünster, , Germany
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Neuwied, , Germany
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Nittenau, , Germany
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Northeim, , Germany
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Oberhausen, , Germany
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Oberndorf, , Germany
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Oberursel, , Germany
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Offenbach, , Germany
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Osnabrück, , Germany
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Pforzheim, , Germany
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Pirna, , Germany
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Regensburg, , Germany
Novo Nordisk Investigational Site
Rehlingen-Siersburg, , Germany
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Saaldorf, , Germany
Novo Nordisk Investigational Site
Saarbrücken, , Germany
Novo Nordisk Investigational Site
Saint Ingbert, , Germany
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Sangerhausen, , Germany
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Schaafheim, , Germany
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Schkeuditz, , Germany
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Schlüchtern, , Germany
Novo Nordisk Investigational Site
Schwerin, , Germany
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Schwerin, , Germany
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Schwerte, , Germany
Novo Nordisk Investigational Site
Siegen, , Germany
Novo Nordisk Investigational Site
Simmern, , Germany
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Sinsheim, , Germany
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Sögel, , Germany
Novo Nordisk Investigational Site
Speyer, , Germany
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Stuttgart, , Germany
Novo Nordisk Investigational Site
Sulzbach-Rosenberg, , Germany
Novo Nordisk Investigational Site
Trier, , Germany
Novo Nordisk Investigational Site
Tübingen, , Germany
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Völklingen, , Germany
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Wallerfing, , Germany
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Wangen, , Germany
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Warburg, , Germany
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Wiesbaden, , Germany
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Wilhelmshaven, , Germany
Novo Nordisk Investigational Site
Würzburg, , Germany
Novo Nordisk Investigational Site
Basel-Bruderholz, , Switzerland
Novo Nordisk Investigational Site
Geneva, , Switzerland
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Lugano, , Switzerland
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Sankt Gallen, , Switzerland
Novo Nordisk Investigational Site
Zurich, , Switzerland
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN304-1558
Identifier Type: -
Identifier Source: org_study_id
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