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

NCT00184574 | Completed Phase 3

• 1 other identifier: BIASP-1440
• Study Type: interventional
• Target: 603
• Locations: 18 countries
• Sites: 108

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c

  after 36 weeks

Secondary Outcomes (3)

• 8-point plasma glucose profiles

• Safety variables

• Other glycemic variables

Interventions

biphasic insulin aspart DRUG

metformin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• Currently treated with insulin
• Currently treated with Metformin
• HbA1c: 7.5-12.0%

You may not qualify if:

• Body Mass Index (BMI) \< 25.0 or \> 40.0 kg/m2
• Metformin contraindications according to local practice
• TZDs within 6 months prior to randomisation

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (108)

Novo Nordisk Investigational Site

Bregenz, A - 6900, Austria

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Novo Nordisk Investigational Site

Feldkirch, 6807, Austria

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Graz, 8036, Austria

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Salzburg, 5010, Austria

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Vienna, A-1130, Austria

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Bonheiden, 2820, Belgium

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Brussels, 1070, Belgium

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Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Liège, 4000, Belgium

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Pleven, 5800, Bulgaria

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Sofia, 1431, Bulgaria

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Brno, 65691, Czechia

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Hradec Králové, 500 36, Czechia

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Prague, 15018, Czechia

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Århus C, 8000, Denmark

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Køge, 4600, Denmark

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Odense, 5000, Denmark

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Antibes, 06600, France

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Boulogne-Billancourt, 92100, France

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Brest, 29609, France

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La Rochelle, 17019, France

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Le Chesnay, 78150, France

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Lille, 59037, France

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Metz, 57000, France

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Mougins, 06250, France

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Narbonne, 11108, France

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Nevers, 58033, France

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Perpignan, 66046, France

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Bad Heilbrunn, 83670, Germany

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Beckum, 59269, Germany

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Berlin, 10318, Germany

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Dormagen, 41539, Germany

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Dresden, 01219, Germany

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Duisburg, 47259, Germany

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Genthin, 39307, Germany

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Kippenheim, 77971, Germany

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München, 81479, Germany

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Pohlheim, 35415, Germany

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Saarbrücken, 66121, Germany

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Saint Ingbert, 66386, Germany

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Schönebeck, 39218, Germany

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Völklingen, 66333, Germany

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Würzburg, 97072, Germany

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Budapest, 1125, Hungary

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Debrecen, 4043, Hungary

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Veszprém, 8200, Hungary

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Catania, 95126, Italy

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Florence, 50141, Italy

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Gazi, 98124, Italy

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Lucca, 55100, Italy

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Milan, 20157, Italy

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Padua, 35143, Italy

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Roma, 00133, Italy

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Roma, 00195, Italy

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Salerno, 84125, Italy

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Savigliano (CN), 12038, Italy

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Terni, 05100, Italy

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Udine, 33100, Italy

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's-Hertogenbosch, 5223 GV, Netherlands

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Amersfoort, 3816 CP, Netherlands

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Brunssum, 6442 BE, Netherlands

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Hoogeveen, 7909 AA, Netherlands

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Roosendaal, 4708 AE, Netherlands

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Rotterdam, 3011 TD, Netherlands

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Lublin, 20-538, Poland

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Mazowieckie, 09-400, Poland

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Poznan, 61-696, Poland

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Szczecin, 71-455, Poland

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Warsaw, 01-911, Poland

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Zabrze, 41-800, Poland

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Ploieşti, Prahova, 100097, Romania

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Galati, 800578, Romania

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Suceava, 720062, Romania

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Târgu Mureş, 540061, Romania

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Moscow, 117036, Russia

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Moscow, 123448, Russia

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Moscow, 127644, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 198013, Russia

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Ljubljana, 1000, Slovenia

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Albacete, 02006, Spain

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Granada, 18012, Spain

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L'Hospitalet de Llobregat, 08907, Spain

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Madrid, 28040, Spain

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Madrid, 28046, Spain

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Mostoles - Madrid -, 28935, Spain

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Palma de Mallorca, 07014, Spain

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San Juan, 03550, Spain

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Valencia, 46014, Spain

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Zaragoza, 50009, Spain

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Biel, 2502, Switzerland

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Interlaken-Unterseen, 3800, Switzerland

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Sankt Gallen, 9000, Switzerland

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Winterthur, 8400, Switzerland

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Zurich, 8002, Switzerland

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Ankara, 06630, Turkey (Türkiye)

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Bursa, 16059, Turkey (Türkiye)

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Istanbul, 34098, Turkey (Türkiye)

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Bradford, BD9 6RJ, United Kingdom

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Brighton, BN2 5BE, United Kingdom

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Bristol, BS10 5NB, United Kingdom

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Cosham, PO6 3LY, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Plymouth, PL8 8DQ, United Kingdom

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Salford, M6 8HD, United Kingdom

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Sheffield, S5 7AU, United Kingdom

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Watford, WD18 0HB, United Kingdom

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Related Publications (2)

• 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.

  PMID: 17697056 RESULT

• 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.

  PMID: 19476479 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: April 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: January 5, 2017

Record last verified: 2017-01

Locations

ES (10); TU (3); BE (5); HU (3); NL (6); RU (5); DK (3); BU (2); GB (9); AU (5); FR (11); IT (12); CZ (3); SL (1); RO (4); PL (6); CH (5); DE (15)