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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00605111
First received: January 18, 2008
Last updated: January 10, 2017
Last verified: January 2017

January 18, 2008
January 10, 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 ClinicalTrials.gov 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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
193
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)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Hong Kong,   Malaysia,   Philippines,   Singapore,   Taiwan,   Thailand
 
 
NCT00605111
BIASP-3021
No
Not Provided
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