Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00605111
Recruitment Status : Completed
First Posted : January 30, 2008
Last Update Posted : January 11, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

January 18, 2008
January 30, 2008
January 11, 2017
December 2003
October 2004   (Final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 11 weeks of treatment ]
Same as current
Complete list of historical versions of study NCT00605111 on Archive Site
  • The proportion of subjects achieving treatment target of HbA1c below 7% [ Time Frame: at 11 and 24 weeks ]
  • 8-point plasma glucose profiles [ Time Frame: performed at 11 and 24 weeks ]
  • FPG [ Time Frame: at 11 weeks and 24 weeks ]
Same as current
Not Provided
Not Provided
Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes
Efficacy and Safety of Initiation of Biphasic Insulin Aspart 30 Treatment in Subjects With Type 2 Diabetes Mellitus Failing OAD Therapy
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart 30 as start insulin in subjects with type 2 diabetes failing OAD therapy.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Not Provided
Bebakar WM, Chow CC, Kadir KA, Suwanwalaikorn S, Vaz JA, Bech OM; BIAsp-3021 study group. Adding biphasic insulin aspart 30 once or twice daily is more efficacious than optimizing oral antidiabetic treatment in patients with type 2 diabetes. Diabetes Obes Metab. 2007 Sep;9(5):724-32. Epub 2007 Jun 26.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2004
October 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes for at least 24 months
  • BMI between 18 and 30 kg/m2
  • Insulin naive subjects
  • OAD treatment with max two OADs alone or combined with other therapy
  • HbA1c between 7-12%

Exclusion Criteria:

  • Type 1 diabetes
  • Receipt of any investigational drug within the last three months prior to this trial
  • Current or previous treatment with thiazolidiones within the last 6 months
  • OAD treatment with three or more OADs within the last 4 months
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   Hong Kong,   Malaysia,   Philippines,   Singapore,   Taiwan,   Thailand
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

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