Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184574
First received: September 12, 2005
Last updated: January 4, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Drug: metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 8-point plasma glucose profiles [ Designated as safety issue: No ]
  • Safety variables [ Designated as safety issue: No ]
  • Other glycemic variables [ Designated as safety issue: No ]

Enrollment: 603
Study Start Date: April 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184574

  Hide Study Locations
Locations
Austria
Novo Nordisk Investigational Site
Bregenz, Austria, A - 6900
Novo Nordisk Investigational Site
Feldkirch, Austria, 6807
Novo Nordisk Investigational Site
Graz, Austria, 8036
Novo Nordisk Investigational Site
Salzburg, Austria, 5010
Novo Nordisk Investigational Site
Wien, Austria, A-1130
Belgium
Novo Nordisk Investigational Site
Bonheiden, Belgium, 2820
Novo Nordisk Investigational Site
Brussels, Belgium, 1070
Novo Nordisk Investigational Site
Genk, Belgium, 3600
Novo Nordisk Investigational Site
Gent, Belgium, 9000
Novo Nordisk Investigational Site
Liège, Belgium, 4000
Bulgaria
Novo Nordisk Investigational Site
Pleven, Bulgaria, 5800
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1431
Czech Republic
Novo Nordisk Investigational Site
Brno, Czech Republic, 65691
Novo Nordisk Investigational Site
Hradec Králové, Czech Republic, 500 36
Novo Nordisk Investigational Site
Praha 5, Czech Republic, 15018
Denmark
Novo Nordisk Investigational Site
Køge, Denmark, 4600
Novo Nordisk Investigational Site
Odense, Denmark, 5000
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
France
Novo Nordisk Investigational Site
Antibes, France, 06600
Novo Nordisk Investigational Site
Boulogne-billancourt, France, 92100
Novo Nordisk Investigational Site
Brest, France, 29609
Novo Nordisk Investigational Site
LA ROCHELLE cedex, France, 17019
Novo Nordisk Investigational Site
Le Chesnay, France, 78150
Novo Nordisk Investigational Site
Lille, France, 59037
Novo Nordisk Investigational Site
Metz, France, 57000
Novo Nordisk Investigational Site
Mougins, France, 06250
Novo Nordisk Investigational Site
Narbonne, France, 11108
Novo Nordisk Investigational Site
NEVERS cedex, France, 58033
Novo Nordisk Investigational Site
PERPIGNAN cedex, France, 66046
Germany
Novo Nordisk Investigational Site
Bad Heilbrunn, Germany, 83670
Novo Nordisk Investigational Site
Beckum, Germany, 59269
Novo Nordisk Investigational Site
Berlin, Germany, 10318
Novo Nordisk Investigational Site
Dormagen, Germany, 41539
Novo Nordisk Investigational Site
Dresden, Germany, 01219
Novo Nordisk Investigational Site
Duisburg, Germany, 47259
Novo Nordisk Investigational Site
Genthin, Germany, 39307
Novo Nordisk Investigational Site
Kippenheim, Germany, 77971
Novo Nordisk Investigational Site
München, Germany, 81479
Novo Nordisk Investigational Site
Pohlheim, Germany, 35415
Novo Nordisk Investigational Site
Saarbrücken, Germany, 66121
Novo Nordisk Investigational Site
Schönebeck, Germany, 39218
Novo Nordisk Investigational Site
St. Ingbert, Germany, 66386
Novo Nordisk Investigational Site
Völklingen, Germany, 66333
Novo Nordisk Investigational Site
Würzburg, Germany, 97072
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, 1125
Novo Nordisk Investigational Site
Debrecen, Hungary, 4043
Novo Nordisk Investigational Site
Veszprem, Hungary, 8200
Italy
Novo Nordisk Investigational Site
Catania, Italy, 95126
Novo Nordisk Investigational Site
Firenze, Italy, 50141
Novo Nordisk Investigational Site
Gazi, Italy, 98124
Novo Nordisk Investigational Site
Lucca, Italy, 55100
Novo Nordisk Investigational Site
Milano, Italy, 20157
Novo Nordisk Investigational Site
Padova, Italy, 35143
Novo Nordisk Investigational Site
Roma, Italy, 00133
Novo Nordisk Investigational Site
Roma, Italy, 00195
Novo Nordisk Investigational Site
Salerno, Italy, 84125
Novo Nordisk Investigational Site
Savigliano (CN), Italy, 12038
Novo Nordisk Investigational Site
Terni, Italy, 05100
Novo Nordisk Investigational Site
Udine, Italy, 33100
Netherlands
Novo Nordisk Investigational Site
Amersfoort, Netherlands, 3816 CP
Novo Nordisk Investigational Site
Brunssum, Netherlands, 6442 BE
Novo Nordisk Investigational Site
Den Bosch, Netherlands, 5223 GV
Novo Nordisk Investigational Site
Hoogeveen, Netherlands, 7909 AA
Novo Nordisk Investigational Site
Roosendaal, Netherlands, 4708 AE
Novo Nordisk Investigational Site
Rotterdam, Netherlands, 3011 TD
Poland
Novo Nordisk Investigational Site
Lublin, Poland, 20-538
Novo Nordisk Investigational Site
Mazowieckie, Poland, 09-400
Novo Nordisk Investigational Site
Poznan, Poland, 61-696
Novo Nordisk Investigational Site
Szczecin, Poland, 71-455
Novo Nordisk Investigational Site
Warsaw, Poland, 01-911
Novo Nordisk Investigational Site
Zabrze, Poland, 41-800
Romania
Novo Nordisk Investigational Site
Ploiesti, Prahova, Romania, 100097
Novo Nordisk Investigational Site
Galati, Romania, 800578
Novo Nordisk Investigational Site
Suceava, Romania, 720062
Novo Nordisk Investigational Site
Targu-Mures, Romania, 540061
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 117036
Novo Nordisk Investigational Site
Moscow, Russian Federation, 123448
Novo Nordisk Investigational Site
Moscow, Russian Federation, 127644
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 194354
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 198013
Slovenia
Novo Nordisk Investigational Site
Ljubljana, Slovenia, 1000
Spain
Novo Nordisk Investigational Site
Albacete, Spain, 02006
Novo Nordisk Investigational Site
Granada, Spain, 18012
Novo Nordisk Investigational Site
Hospitalet de Llobregat, Spain, 08907
Novo Nordisk Investigational Site
Madrid, Spain, 28040
Novo Nordisk Investigational Site
Madrid, Spain, 28046
Novo Nordisk Investigational Site
Mostoles - Madrid -, Spain, 28935
Novo Nordisk Investigational Site
Palma de Mallorca, Spain, 07014
Novo Nordisk Investigational Site
San Juan, Spain, 03550
Novo Nordisk Investigational Site
Valencia, Spain, 46014
Novo Nordisk Investigational Site
Zaragoza, Spain, 50009
Switzerland
Novo Nordisk Investigational Site
Biel, Switzerland, 2502
Novo Nordisk Investigational Site
Interlaken-Unterseen, Switzerland, 3800
Novo Nordisk Investigational Site
St. Gallen, Switzerland, 9000
Novo Nordisk Investigational Site
Winterthur, Switzerland, 8400
Novo Nordisk Investigational Site
Zürich, Switzerland, 8002
Turkey
Novo Nordisk Investigational Site
Ankara, Turkey, 06630
Novo Nordisk Investigational Site
Bursa, Turkey, 16059
Novo Nordisk Investigational Site
Istanbul, Turkey, 34098
United Kingdom
Novo Nordisk Investigational Site
Bradford, United Kingdom, BD9 6RJ
Novo Nordisk Investigational Site
Brighton, United Kingdom, BN2 5BE
Novo Nordisk Investigational Site
Bristol, United Kingdom, BS10 5NB
Novo Nordisk Investigational Site
Cosham, United Kingdom, PO6 3LY
Novo Nordisk Investigational Site
Dundee, United Kingdom, DD1 9SY
Novo Nordisk Investigational Site
Plymouth, United Kingdom, PL8 8DQ
Novo Nordisk Investigational Site
Salford, United Kingdom, M6 8HD
Novo Nordisk Investigational Site
Sheffield, United Kingdom, S5 7AU
Novo Nordisk Investigational Site
Watford, United Kingdom, WD18 0HB
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184574     History of Changes
Other Study ID Numbers: BIASP-1440 
Study First Received: September 12, 2005
Last Updated: January 4, 2017
Health Authority: Bulgaria: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Russia: Pharmacological Committee, Ministry of Health
Turkey: Ministry of Health Drug and Pharmaceutical Department
Denmark: Danish Medicines Agency
Poland: Ministry of Health
Romania: National Medicines Agency
Hungary: National Institute of Pharmacy
Netherlands: Dutch Health Care Inspectorate
Czech Republic: State Institute for Drug Control
Austria: Federal Ministry for Health and Women
Italy: The Italian Medicines Agency
Slovenia: Agency for Medicinal Products - Ministry of Health
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Metformin
Biphasic Insulins
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on January 17, 2017