Status:

COMPLETED

Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Diabetes

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare two different active treatment regimens of biphasic insulin aspart in subjects with type 2 diabetes.

Eligibility Criteria

Inclusion

  • Type 2 diabetes
  • Duration of diabetes for longer than 12 months
  • Body mass index (BMI) below 35.0 kg/m\^2
  • HbA1c below 11.0 %
  • Treatment with BHI (biphasic human insulin) 20 or 30 twice daily for at least three months and in the last month as sole anti-diabetic treatment (i.e., no additional oral hypoglycaemic medication or daily use of short-acting insulin supplement)

Exclusion

  • Current treatment with agents affecting glucose metabolism
  • History of drug or alcohol dependence
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac disease
  • Proliferative retinopathy
  • Recurrent severe hypoglycaemia or advanced neuropathy

Key Trial Info

Start Date :

March 1 1999

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 1999

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT01520753

Start Date

March 1 1999

End Date

June 1 1999

Last Update

January 4 2017

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Novo Nordisk Investigational Site

Århus C, Denmark, 8000