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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00605111
First received: January 18, 2008
Last updated: June 5, 2012
Last verified: June 2012
History of Changes

January 18, 2008
June 5, 2012
December 2003
October 2004   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 11 weeks of treatment ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: after 11 weeks of treatment ]
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 ] [ Designated as safety issue: No ]
  • 8-point plasma glucose profiles [ Time Frame: performed at 11 and 24 weeks ] [ Designated as safety issue: No ]
  • FPG [ Time Frame: at 11 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • 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 ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Not Provided
Not Provided

*   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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Hong Kong,   Malaysia,   Philippines,   Singapore,   Taiwan,   Thailand
 
NCT00605111
BIASP-3021
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Plamen Kozlovski Novo Nordisk
Novo Nordisk
June 2012

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