Efficacy and Safety of Insulin Aspart Versus Glibenclamide in Type 2 Diabetes

This study has been terminated.
(This trial was terminated due to low recruitment)
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00267683
First received: December 20, 2005
Last updated: April 12, 2013
Last verified: November 2012

December 20, 2005
April 12, 2013
December 2005
April 2006   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
- HbA1C after 24 weeks of treatment
Complete list of historical versions of study NCT00267683 on ClinicalTrials.gov Archive Site
  • Plasma glucose levels [ Designated as safety issue: No ]
  • Percentage of subjects achieving the treatment target of HbA1c value < 6.5% [ Designated as safety issue: No ]
  • - Plasma glucose levels
  • - Percentage of subjects achieving the treatment target of HbA1C value < 6,5%
Not Provided
Not Provided
 
Efficacy and Safety of Insulin Aspart Versus Glibenclamide in Type 2 Diabetes
A Clinical Trial to Study the Efficacy and Safety of Insulin Aspart Three Times Per Day Compared to Glibenclamide Once or Twice Daily in Type 2 Diabetes by Comparison of Ability to Control Blood Glucose

This trial is conducted in Japan. This is a clinical trial to study the efficacy and safety of thrice daily Insulin Aspart compared to Glibenclamide in type 2 diabetic patients.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin aspart
  • Drug: glibenclamide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
April 2006
April 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes
  • Diet therapy for at least 12 weeks, or diet therapy and oral hypoglycaemic agent(s) other than SU agents for at least 12 weeks
  • No previous treatment with insulin and/or SU agents
  • HbA1c between 7.5% and 10.0%
  • Body Mass Index (BMI) below 30.0 kg/m2

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac diseases
  • Uncontrolled hypertension
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia
  • Current treatment with systemic corticosteroids
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00267683
ANA-1667, JapicCTI-060200
No
Not Provided
Novo Nordisk A/S
Not Provided
Study Director: Michiaki Kanai, DVM, MSc. Novo Nordisk Pharma Limited Japan
Novo Nordisk A/S
November 2012

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