Status:

TERMINATED

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

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Diabetes

Diabetes Mellitus, Type 2

Eligibility:

All Genders

20+ years

Phase:

PHASE3

Brief Summary

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2006

Estimated Enrollment :

9 Patients enrolled

Trial Details

Trial ID

NCT00267683

Start Date

December 1 2005

End Date

April 1 2006

Last Update

November 2 2023

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