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:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184574
First received: September 12, 2005
Last updated: October 18, 2013
Last verified: October 2013

September 12, 2005
October 18, 2013
April 2005
March 2006   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 36 weeks ] [ Designated as safety issue: No ]
HbA1c after 36 weeks
Complete list of historical versions of study NCT00184574 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 8-point plasma glucose profiles
  • Safety variables
  • Other glycemic variables
Not Provided
Not Provided
 
Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 Diabetes
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: biphasic insulin aspart
  • Drug: metformin
Not Provided
Cucinotta D, Smirnova O, Christiansen JS, Kanc K, le Devehat C, Wojciechowska M, López 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. Epub 2009 May 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
603
March 2006
March 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Romania,   Belgium,   Bulgaria,   Czech Republic,   Denmark,   France,   Germany,   Hungary,   Italy,   Netherlands,   Poland,   United Kingdom,   Russian Federation,   Slovenia,   Spain,   Switzerland,   Turkey,   Austria
 
NCT00184574
BIASP-1440
No
Not Provided
Novo Nordisk A/S
Not Provided
Study Director: Malene B. Krüger Novo Nordisk A/S
Novo Nordisk A/S
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP