Status:

COMPLETED

Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Diabetes

Diabetes Mellitus, Type 2

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects w...

Eligibility Criteria

Inclusion

  • Type 2 diabetes for at least 24 months
  • Insulin treatment for the pase 3 months
  • HbA1c (glycosylated haemoglobin) below 13%
  • BMI (Body Mass Index) below 40 kg/m\^2
  • Ability and willingness to perform self-blood glucose monitoring

Exclusion

  • Receipt of any investigational drug within 4 weeks prior to this trial
  • Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial
  • Total daily insulin dosage less than or equal to 1.8 IU/kg

Key Trial Info

Start Date :

August 19 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 15 2003

Estimated Enrollment :

292 Patients enrolled

Trial Details

Trial ID

NCT01467401

Start Date

August 19 2002

End Date

May 15 2003

Last Update

February 24 2017

Active Locations (57)

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Page 1 of 15 (57 locations)

1

Novo Nordisk Investigational Site

Århus C, Denmark, 8000

2

Novo Nordisk Investigational Site

Esbjerg, Denmark, 6700

3

Novo Nordisk Investigational Site

Herning, Denmark, 7400

4

Novo Nordisk Investigational Site

Holbæk, Denmark, 4300

Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes | DecenTrialz