Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30, Biphasic Insulin Aspart 50/50, and Biphasic Insulin Aspart 30/70 All in Combination With Metformin in Subjects With Type 2 Diabetes (the INTENSIMIX Trial).
This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug.
| Status | Completed |
| Enrollment | 603 |
| Est. completion date | March 2006 |
| Est. primary completion date | March 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Type 2 diabetes - Currently treated with insulin - Currently treated with Metformin - HbA1c: 7.5-12.0% Exclusion Criteria: - Body Mass Index (BMI) < 25.0 or > 40.0 kg/m2 - Metformin contraindications according to local practice - TZDs within 6 months prior to randomisation |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Novo Nordisk Investigational Site | Bregenz | |
| Austria | Novo Nordisk Investigational Site | Feldkirch | |
| Austria | Novo Nordisk Investigational Site | Graz | |
| Austria | Novo Nordisk Investigational Site | Salzburg | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Belgium | Novo Nordisk Investigational Site | Bonheiden | |
| Belgium | Novo Nordisk Investigational Site | Brussels | |
| Belgium | Novo Nordisk Investigational Site | Genk | |
| Belgium | Novo Nordisk Investigational Site | Gent | |
| Belgium | Novo Nordisk Investigational Site | Liège | |
| Bulgaria | Novo Nordisk Investigational Site | Pleven | |
| Bulgaria | Novo Nordisk Investigational Site | Sofia | |
| Czech Republic | Novo Nordisk Investigational Site | Brno | |
| Czech Republic | Novo Nordisk Investigational Site | Hradec Králové | |
| Czech Republic | Novo Nordisk Investigational Site | Praha 5 | |
| Denmark | Novo Nordisk Investigational Site | Århus C | |
| Denmark | Novo Nordisk Investigational Site | Køge | |
| Denmark | Novo Nordisk Investigational Site | Odense | |
| France | Novo Nordisk Investigational Site | Antibes | |
| France | Novo Nordisk Investigational Site | Boulogne-billancourt | |
| France | Novo Nordisk Investigational Site | Brest | |
| France | Novo Nordisk Investigational Site | LA ROCHELLE cedex | |
| France | Novo Nordisk Investigational Site | Le Chesnay | |
| France | Novo Nordisk Investigational Site | Lille | |
| France | Novo Nordisk Investigational Site | Metz | |
| France | Novo Nordisk Investigational Site | Mougins | |
| France | Novo Nordisk Investigational Site | Narbonne | |
| France | Novo Nordisk Investigational Site | NEVERS cedex | |
| France | Novo Nordisk Investigational Site | PERPIGNAN cedex | |
| Germany | Novo Nordisk Investigational Site | Bad Heilbrunn | |
| Germany | Novo Nordisk Investigational Site | Beckum | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Dormagen | |
| Germany | Novo Nordisk Investigational Site | Dresden | |
| Germany | Novo Nordisk Investigational Site | Duisburg | |
| Germany | Novo Nordisk Investigational Site | Genthin | |
| Germany | Novo Nordisk Investigational Site | Kippenheim | |
| Germany | Novo Nordisk Investigational Site | München | |
| Germany | Novo Nordisk Investigational Site | Pohlheim | |
| Germany | Novo Nordisk Investigational Site | Saarbrücken | |
| Germany | Novo Nordisk Investigational Site | Schönebeck | |
| Germany | Novo Nordisk Investigational Site | St. Ingbert | |
| Germany | Novo Nordisk Investigational Site | Völklingen | |
| Germany | Novo Nordisk Investigational Site | Würzburg | |
| Hungary | Novo Nordisk Investigational Site | Budapest | |
| Hungary | Novo Nordisk Investigational Site | Debrecen | |
| Hungary | Novo Nordisk Investigational Site | Veszprem | |
| Italy | Novo Nordisk Investigational Site | Catania | |
| Italy | Novo Nordisk Investigational Site | Firenze | |
| Italy | Novo Nordisk Investigational Site | Gazi | |
| Italy | Novo Nordisk Investigational Site | Lucca | |
| Italy | Novo Nordisk Investigational Site | Milano | |
| Italy | Novo Nordisk Investigational Site | Padova | |
| Italy | Novo Nordisk Investigational Site | Roma | |
| Italy | Novo Nordisk Investigational Site | Roma | |
| Italy | Novo Nordisk Investigational Site | Salerno | |
| Italy | Novo Nordisk Investigational Site | Savigliano (CN) | |
| Italy | Novo Nordisk Investigational Site | Terni | |
| Italy | Novo Nordisk Investigational Site | Udine | |
| Netherlands | Novo Nordisk Investigational Site | Amersfoort | |
| Netherlands | Novo Nordisk Investigational Site | Brunssum | |
| Netherlands | Novo Nordisk Investigational Site | Den Bosch | |
| Netherlands | Novo Nordisk Investigational Site | Hoogeveen | |
| Netherlands | Novo Nordisk Investigational Site | Roosendaal | |
| Netherlands | Novo Nordisk Investigational Site | Rotterdam | |
| Poland | Novo Nordisk Investigational Site | Lublin | |
| Poland | Novo Nordisk Investigational Site | Mazowieckie | |
| Poland | Novo Nordisk Investigational Site | Poznan | |
| Poland | Novo Nordisk Investigational Site | Szczecin | |
| Poland | Novo Nordisk Investigational Site | Warsaw | |
| Poland | Novo Nordisk Investigational Site | Zabrze | |
| Romania | Novo Nordisk Investigational Site | Galati | |
| Romania | Novo Nordisk Investigational Site | Ploiesti | Prahova |
| Romania | Novo Nordisk Investigational Site | Suceava | |
| Romania | Novo Nordisk Investigational Site | Targu-Mures | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Saint-Petersburg | |
| Russian Federation | Novo Nordisk Investigational Site | Saint-Petersburg | |
| Slovenia | Novo Nordisk Investigational Site | Ljubljana | |
| Spain | Novo Nordisk Investigational Site | Albacete | |
| Spain | Novo Nordisk Investigational Site | Granada | |
| Spain | Novo Nordisk Investigational Site | Hospitalet de Llobregat | |
| Spain | Novo Nordisk Investigational Site | Madrid | |
| Spain | Novo Nordisk Investigational Site | Madrid | |
| Spain | Novo Nordisk Investigational Site | Mostoles - Madrid - | |
| Spain | Novo Nordisk Investigational Site | Palma de Mallorca | |
| Spain | Novo Nordisk Investigational Site | San Juan | |
| Spain | Novo Nordisk Investigational Site | Valencia | |
| Spain | Novo Nordisk Investigational Site | Zaragoza | |
| Switzerland | Novo Nordisk Investigational Site | Biel | |
| Switzerland | Novo Nordisk Investigational Site | Interlaken-Unterseen | |
| Switzerland | Novo Nordisk Investigational Site | St. Gallen | |
| Switzerland | Novo Nordisk Investigational Site | Winterthur | |
| Switzerland | Novo Nordisk Investigational Site | Zürich | |
| Turkey | Novo Nordisk Investigational Site | Ankara | |
| Turkey | Novo Nordisk Investigational Site | Bursa | |
| Turkey | Novo Nordisk Investigational Site | Istanbul | |
| United Kingdom | Novo Nordisk Investigational Site | Bradford | |
| United Kingdom | Novo Nordisk Investigational Site | Brighton | |
| United Kingdom | Novo Nordisk Investigational Site | Bristol | |
| United Kingdom | Novo Nordisk Investigational Site | Cosham | |
| United Kingdom | Novo Nordisk Investigational Site | Dundee | |
| United Kingdom | Novo Nordisk Investigational Site | Plymouth | |
| United Kingdom | Novo Nordisk Investigational Site | Salford | |
| United Kingdom | Novo Nordisk Investigational Site | Sheffield | |
| United Kingdom | Novo Nordisk Investigational Site | Watford |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Russian Federation, Slovenia, Spain, Switzerland, Turkey, United Kingdom,
Cucinotta D, Smirnova O, Christiansen JS, Kanc K, le Devehat C, Wojciechowska M, López de la Torre M, Liebl A. Three different premixed combinations of biphasic insulin aspart - comparison of the efficacy and safety in a randomized controlled clinical tri — View Citation
Garber AJ, Ligthelm R, Christiansen JS, Liebl A. Premixed insulin treatment for type 2 diabetes: analogue or human? Diabetes Obes Metab. 2007 Sep;9(5):630-9. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c | after 36 weeks | No | |
| Secondary | 8-point plasma glucose profiles | No | ||
| Secondary | Safety variables | No | ||
| Secondary | Other glycemic variables | No |
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