Status:
COMPLETED
Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
The trial is conducted in Europe and Middle East. The aim of the trial is to compare the use of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of NPH Insulin on...
Eligibility Criteria
Inclusion
- Type 1 diabetes for at least 12 months
- Informed consent obtained
- BMI: 6-7 years: less than or equal to 19 kg/m2, 8-9 years: less than or equal to 20 kg/m2, 10-11 years: less than or equal to 22 kg/m2, 12-13 years: less than or equal to 24 kg/m2 and 14-17 years: less than or equal to 27 kg/m2.
- HbA1c equal to or less than 12.0%
Exclusion
- Proliferate retinopathy or maculopathy
- Total daily insulin dose greater than 2.00 IU/kg
- Any condition or disease that rule out trial participation according to the judgement of the investigator.
- Mental incapacity, unwillingness or language barriers precluding understanding or cooperation.
- A life-style incompatible with trial participation
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2003
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT00312156
Start Date
August 1 2002
End Date
August 1 2003
Last Update
January 27 2017
Active Locations (42)
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1
Novo Nordisk Investigational Site
Bree, Belgium, 3960
2
Novo Nordisk Investigational Site
Edegem, Belgium, 2650
3
Novo Nordisk Investigational Site
Rijeka, Croatia, 51 000
4
Novo Nordisk Investigational Site
Glostrup Municipality, Denmark, 2600