Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 Diabetes

NCT ID: NCT00184574

Last Updated: 2017-01-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

603 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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biphasic insulin aspart

Intervention Type DRUG

metformin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Bregenz, , Austria

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Novo Nordisk Investigational Site

Feldkirch, , Austria

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Graz, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Bonheiden, , Belgium

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Brussels, , Belgium

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Genk, , Belgium

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Ghent, , Belgium

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Liège, , Belgium

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Pleven, , Bulgaria

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Sofia, , Bulgaria

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Brno, , Czechia

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Hradec Králové, , Czechia

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Prague, , Czechia

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Århus C, , Denmark

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Køge, , Denmark

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Odense, , Denmark

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Antibes, , France

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Boulogne-Billancourt, , France

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Brest, , France

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La Rochelle, , France

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Le Chesnay, , France

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Lille, , France

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Metz, , France

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Mougins, , France

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Narbonne, , France

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Nevers, , France

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Perpignan, , France

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Bad Heilbrunn, , Germany

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Beckum, , Germany

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Berlin, , Germany

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Dormagen, , Germany

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Dresden, , Germany

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Duisburg, , Germany

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Genthin, , Germany

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Kippenheim, , Germany

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München, , Germany

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Pohlheim, , Germany

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Saarbrücken, , Germany

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Saint Ingbert, , Germany

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Schönebeck, , Germany

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Völklingen, , Germany

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Würzburg, , Germany

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Budapest, , Hungary

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Debrecen, , Hungary

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Veszprém, , Hungary

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Catania, , Italy

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Florence, , Italy

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Gazi, , Italy

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Lucca, , Italy

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Milan, , Italy

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Padua, , Italy

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Roma, , Italy

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Roma, , Italy

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Salerno, , Italy

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Savigliano (CN), , Italy

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Terni, , Italy

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Udine, , Italy

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's-Hertogenbosch, , Netherlands

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Amersfoort, , Netherlands

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Brunssum, , Netherlands

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Hoogeveen, , Netherlands

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Roosendaal, , Netherlands

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Rotterdam, , Netherlands

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Lublin, , Poland

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Mazowieckie, , Poland

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Poznan, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Zabrze, , Poland

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Ploieşti, Prahova, Romania

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Galati, , Romania

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Suceava, , Romania

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Târgu Mureş, , Romania

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Ljubljana, , Slovenia

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Albacete, , Spain

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Granada, , Spain

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L'Hospitalet de Llobregat, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Mostoles - Madrid -, , Spain

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Palma de Mallorca, , Spain

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San Juan, , Spain

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Valencia, , Spain

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Zaragoza, , Spain

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Biel, , Switzerland

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Interlaken-Unterseen, , Switzerland

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Sankt Gallen, , Switzerland

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Winterthur, , Switzerland

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Zurich, , Switzerland

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Ankara, , Turkey (Türkiye)

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Bursa, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Bradford, , United Kingdom

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Brighton, , United Kingdom

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Bristol, , United Kingdom

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Cosham, , United Kingdom

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Dundee, , United Kingdom

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Plymouth, , United Kingdom

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Salford, , United Kingdom

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Sheffield, , United Kingdom

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Watford, , United Kingdom

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Countries

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Austria Belgium Bulgaria Czechia Denmark France Germany Hungary Italy Netherlands Poland Romania Russia Slovenia Spain Switzerland Turkey (Türkiye) United Kingdom

References

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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.

Reference Type RESULT
PMID: 17697056 (View on PubMed)

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.

Reference Type RESULT
PMID: 19476479 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-1440

Identifier Type: -

Identifier Source: org_study_id

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