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Efficacy and Safety of Insulin Aspart Vs. Glibenclamide Thrice Daily in Type 2 Diabetes - Article


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Insulin aspart

Humalog Aspart; Humulin Aspart; insulin aspart [rDNA origin]; Novolin Aspart; NovoLog


Clinical Trial: Efficacy and Safety of Insulin Aspart Vs. Glibenclamide Thrice Daily in Type 2 Diabetes

This study is not yet open for patient recruitment.
Verified by Novo Nordisk December 2005

Sponsored by: Novo Nordisk
Information provided by: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00267683

Purpose

This trial is conducted in Japan.

A clinical trial to study efficacy and safety of thrice daily Insulin Aspart compared to Glibenclamide in type 2 diabetic patients

Condition Intervention Phase
Diabetes Mellitus, Type 2
  Drug: Insulin Aspart
 Drug: Glibenclamide
 Phase III

MedlinePlus related topics:  Diabetes

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Clinical Trial to Study the Efficacy and Safety of Thrice Daily Insulin Aspart Compared to Glibenclamide in Type 2 Diabetes by Comparison of Ability to Control Blood Glucose

Further study details as provided by Novo Nordisk:
Primary Outcomes: - HbA1C after 24 weeks of treatment
Secondary Outcomes: - Plasma glucose levels; - Percentage of subjects achieving the treatment target of HbA1C value < 6,5%
Expected Total Enrollment:  336

Study start: December 2005

Eligibility

Ages Eligible for Study:  20 Years and above,  Genders Eligible for Study:  Both
Criteria

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 > 7.5% and < 10.0%
  • Body Mass Index (BMI) < 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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00267683

Public Access to Clinical Trials - Novo Nordisk.      Please contact NN via email:    clinicaltrials@novonordisk.com

Japan
      The University of Tokyo Hospital, Tokyo,  Japan

Study chairs or principal investigators

Michiaki Kanai, DVM, MSc.,  Study Director,  Novo Nordisk Pharma Limited Japan   

More Information

Study ID Numbers:  ANA-1667
Last Updated:  December 20, 2005
Record first received:  December 20, 2005
ClinicalTrials.gov Identifier:  NCT00267683
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2006-01-10


Source: ClinicalTrials.gov
Cache Date: January 11, 2006

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Page Updated: September 6, 2005
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