Clinical trial NCT00184574: Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 Diabetes
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 603
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: after 36 weeks
Secondary outcomes:
measure: 8-point plasma glucose profiles
measure: Safety variables
measure: Other glycemic variables
Other outcomes:
Locations:
city: Bregenz
country: Austria
facility: Novo Nordisk Investigational Site
city: Feldkirch
country: Austria
facility: Novo Nordisk Investigational Site
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
city: Salzburg
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Bonheiden
country: Belgium
facility: Novo Nordisk Investigational Site
city: Brussels
country: Belgium
facility: Novo Nordisk Investigational Site
city: Genk
country: Belgium
facility: Novo Nordisk Investigational Site
city: Gent
country: Belgium
facility: Novo Nordisk Investigational Site
city: Liège
country: Belgium
facility: Novo Nordisk Investigational Site
city: Pleven
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Brno
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Hradec Králové
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Praha 5
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Køge
country: Denmark
facility: Novo Nordisk Investigational Site
city: Odense
country: Denmark
facility: Novo Nordisk Investigational Site
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
city: Antibes
country: France
facility: Novo Nordisk Investigational Site
city: Boulogne-billancourt
country: France
facility: Novo Nordisk Investigational Site
city: Brest
country: France
facility: Novo Nordisk Investigational Site
city: LA ROCHELLE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Le Chesnay
country: France
facility: Novo Nordisk Investigational Site
city: Lille
country: France
facility: Novo Nordisk Investigational Site
city: Metz
country: France
facility: Novo Nordisk Investigational Site
city: Mougins
country: France
facility: Novo Nordisk Investigational Site
city: Narbonne
country: France
facility: Novo Nordisk Investigational Site
city: NEVERS cedex
country: France
facility: Novo Nordisk Investigational Site
city: PERPIGNAN cedex
country: France
facility: Novo Nordisk Investigational Site
city: Bad Heilbrunn
country: Germany
facility: Novo Nordisk Investigational Site
city: Beckum
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Dormagen
country: Germany
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Duisburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Genthin
country: Germany
facility: Novo Nordisk Investigational Site
city: Kippenheim
country: Germany
facility: Novo Nordisk Investigational Site
city: München
country: Germany
facility: Novo Nordisk Investigational Site
city: Pohlheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Saarbrücken
country: Germany
facility: Novo Nordisk Investigational Site
city: Schönebeck
country: Germany
facility: Novo Nordisk Investigational Site
city: St. Ingbert
country: Germany
facility: Novo Nordisk Investigational Site
city: Völklingen
country: Germany
facility: Novo Nordisk Investigational Site
city: Würzburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Debrecen
country: Hungary
facility: Novo Nordisk Investigational Site
city: Veszprem
country: Hungary
facility: Novo Nordisk Investigational Site
city: Catania
country: Italy
facility: Novo Nordisk Investigational Site
city: Firenze
country: Italy
facility: Novo Nordisk Investigational Site
city: Gazi
country: Italy
facility: Novo Nordisk Investigational Site
city: Lucca
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Padova
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Salerno
country: Italy
facility: Novo Nordisk Investigational Site
city: Savigliano (CN)
country: Italy
facility: Novo Nordisk Investigational Site
city: Terni
country: Italy
facility: Novo Nordisk Investigational Site
city: Udine
country: Italy
facility: Novo Nordisk Investigational Site
city: Amersfoort
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Brunssum
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Den Bosch
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Hoogeveen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Roosendaal
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Rotterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Lublin
country: Poland
facility: Novo Nordisk Investigational Site
city: Mazowieckie
country: Poland
facility: Novo Nordisk Investigational Site
city: Poznan
country: Poland
facility: Novo Nordisk Investigational Site
city: Szczecin
country: Poland
facility: Novo Nordisk Investigational Site
city: Warsaw
country: Poland
facility: Novo Nordisk Investigational Site
city: Zabrze
country: Poland
facility: Novo Nordisk Investigational Site
city: Ploiesti
country: Romania
facility: Novo Nordisk Investigational Site
state: Prahova
city: Galati
country: Romania
facility: Novo Nordisk Investigational Site
city: Suceava
country: Romania
facility: Novo Nordisk Investigational Site
city: Targu-Mures
country: Romania
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Ljubljana
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Albacete
country: Spain
facility: Novo Nordisk Investigational Site
city: Granada
country: Spain
facility: Novo Nordisk Investigational Site
city: Hospitalet de Llobregat
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Mostoles - Madrid -
country: Spain
facility: Novo Nordisk Investigational Site
city: Palma de Mallorca
country: Spain
facility: Novo Nordisk Investigational Site
city: San Juan
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Zaragoza
country: Spain
facility: Novo Nordisk Investigational Site
city: Biel
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Interlaken-Unterseen
country: Switzerland
facility: Novo Nordisk Investigational Site
city: St. Gallen
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Winterthur
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Zürich
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Ankara
country: Turkey
facility: Novo Nordisk Investigational Site
city: Bursa
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Bradford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Brighton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bristol
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Cosham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Dundee
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Plymouth
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Salford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Watford
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
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. doi: 10.1111/j.1463-1326.2006.00654.x.
citation: Cucinotta D, Smirnova O, Christiansen JS, Kanc K, le Devehat C, Wojciechowska M, Lopez 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 trial in subjects with type 2 diabetes. Diabetes Obes Metab. 2009 Jul;11(7):700-8. doi: 10.1111/j.1463-1326.2009.01035.x. Epub 2009 May 19.