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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00600366
First received: January 14, 2008
Last updated: June 15, 2012
Last verified: June 2012
History of Changes

January 14, 2008
June 15, 2012
March 2004
January 2005   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: after 12 weeks of treatment ]
Complete list of historical versions of study NCT00600366 on ClinicalTrials.gov Archive Site
  • Blood glucose profiles [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
  • Incidence of adverse events [ Designated as safety issue: No ]
  • Blood glucose profiles
  • Incidence of hypoglycaemic episodes
  • Incidence of adverse events
Not Provided
Not Provided
 
Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 Diabetes
Efficacy and Safety of Biphasic Insulin Aspart 30 in Insulin Naive Type 2 Diabetic Patients With Secondary OHA Failure

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (OHA).
Not Provided
Interventional
Phase 4
Allocation: Non-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
Other Names:
  • BIASP
  • NovoMix 30
  • NovoLog 70/30 Mix
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
71
January 2005
January 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes
  • Insulin naive diabetes
  • Current treatment with OHA, secondary failure
  • Body mass index (BMI) below 40 kg/m2
  • HbA1c over 8.5%
  • Willing and able to start with insulin therapy and to perform self-blood glucose monitoring

Exclusion Criteria:

  • History of drug or alcohol abuse
  • Receipt of the investigational drug within the last month prior to this trial
  • Known or suspected allergy to trial products or related products
  • Severe uncontrolled hypertension
  • Any disease or condition, which the Investigator feels, would interfere with the trial
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Former Serbia and Montenegro
 
NCT00600366
BIASP-1566
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Marija Vujasin, MD Novo Nordisk Pharma doo
Novo Nordisk
June 2012

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