Status:

COMPLETED

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Diabetes

Diabetes Mellitus, Type 1

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily...

Eligibility Criteria

Inclusion

  • Type 1 diabetes for at least 12 months
  • Current daily insulin dose of more than 1.4 IU/kg
  • BMI lesser than or equal to 35 kg/m2
  • HbA1c greater than 7.5% and less than or equal to 12.0%
  • In Austria, age more than 19 years

Exclusion

  • Proliferate retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator

Key Trial Info

Start Date :

April 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2003

Estimated Enrollment :

325 Patients enrolled

Trial Details

Trial ID

NCT00312104

Start Date

April 1 2002

End Date

March 1 2003

Last Update

January 27 2017

Active Locations (46)

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Page 1 of 12 (46 locations)

1

Novo Nordisk Investigational Site

Graz, Austria, 8036

2

Novo Nordisk Investigational Site

Vienna, Austria, 1030

3

Novo Nordisk Investigational Site

Vienna, Austria, 1090

4

Novo Nordisk Investigational Site

Vienna, Austria, A 1160