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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
biphasic insulin aspart
metformin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
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Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

8-point plasma glucose profiles
Safety variables
Other glycemic variables

Full Information

First Posted
September 12, 2005
Last Updated
January 4, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00184574
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
603 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart
Intervention Type
Drug
Intervention Name(s)
metformin
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
after 36 weeks
Secondary Outcome Measure Information:
Title
8-point plasma glucose profiles
Title
Safety variables
Title
Other glycemic variables

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
17697056
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.
Results Reference
result
PubMed Identifier
19476479
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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