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

January 4, 2017 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

603

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - 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
    - Novo Nordisk Investigational Site
Belgium
- - 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
    - Novo Nordisk Investigational Site
Bulgaria
- - Pleven, Bulgaria, 5800
    - Novo Nordisk Investigational Site
  - Sofia, Bulgaria, 1431
    - Novo Nordisk Investigational Site
Czech Republic
- - Brno, Czech Republic, 65691
    - Novo Nordisk Investigational Site
  - Hradec Králové, Czech Republic, 500 36
    - Novo Nordisk Investigational Site
  - Praha 5, Czech Republic, 15018
    - Novo Nordisk Investigational Site
Denmark
- - Køge, Denmark, 4600
    - Novo Nordisk Investigational Site
  - Odense, Denmark, 5000
    - Novo Nordisk Investigational Site
  - Århus C, Denmark, 8000
    - Novo Nordisk Investigational Site
France
- - 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
  - NEVERS cedex, France, 58033
    - Novo Nordisk Investigational Site
  - Narbonne, France, 11108
    - Novo Nordisk Investigational Site
  - PERPIGNAN cedex, France, 66046
    - Novo Nordisk Investigational Site
Germany
- - 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
    - Novo Nordisk Investigational Site
Hungary
- - Budapest, Hungary, 1125
    - Novo Nordisk Investigational Site
  - Debrecen, Hungary, 4043
    - Novo Nordisk Investigational Site
  - Veszprem, Hungary, 8200
    - Novo Nordisk Investigational Site
Italy
- - 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
    - Novo Nordisk Investigational Site
Netherlands
- - 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
    - Novo Nordisk Investigational Site
Poland
- - 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
    - Novo Nordisk Investigational Site
Romania
- - Galati, Romania, 800578
    - Novo Nordisk Investigational Site
  - Suceava, Romania, 720062
    - Novo Nordisk Investigational Site
  - Targu-Mures, Romania, 540061
    - Novo Nordisk Investigational Site
- Prahova
  - Ploiesti, Prahova, Romania, 100097
    - Novo Nordisk Investigational Site
Russian Federation
- - Moscow, Russian Federation, 117036
    - Novo Nordisk Investigational Site
  - Moscow, Russian Federation, 127644
    - Novo Nordisk Investigational Site
  - Moscow, Russian Federation, 123448
    - Novo Nordisk Investigational Site
  - Saint-Petersburg, Russian Federation, 194354
    - Novo Nordisk Investigational Site
  - Saint-Petersburg, Russian Federation, 198013
    - Novo Nordisk Investigational Site
Slovenia
- - Ljubljana, Slovenia, 1000
    - Novo Nordisk Investigational Site
Spain
- - 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
    - Novo Nordisk Investigational Site
Switzerland
- - 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
    - Novo Nordisk Investigational Site
Turkey
- - Ankara, Turkey, 06630
    - Novo Nordisk Investigational Site
  - Bursa, Turkey, 16059
    - Novo Nordisk Investigational Site
  - Istanbul, Turkey, 34098
    - Novo Nordisk Investigational Site
United Kingdom
- - 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
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c Time Frame: after 36 weeks	after 36 weeks

Secondary Outcome Measures

Outcome Measure
Safety variables
Other glycemic variables
8-point plasma glucose profiles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)