Status:
COMPLETED
Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
2-6 years
Phase:
PHASE4
Brief Summary
This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes.
Eligibility Criteria
Inclusion
- Type 1 diabetes
- Treatment with insulin for at least 6 months prior to inclusion
- HbA1c below or equal to 11.0 %
- Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion
Exclusion
- The receipt of any investigational drug within one month prior to this trial
- Recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator
- Total daily insulin doses at least 1.80 IU/kg
- Treatment with oral hypoglycaemic agents
- Known or suspected allergy to trial product or related products
Key Trial Info
Start Date :
June 19 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2003
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01467141
Start Date
June 19 2002
End Date
October 15 2003
Last Update
February 23 2017
Active Locations (6)
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1
Novo Nordisk Investigational Site
Berlin, Germany, 13353
2
Novo Nordisk Investigational Site
Dresden, Germany, 01307
3
Novo Nordisk Investigational Site
Hagen, Germany, 58095
4
Novo Nordisk Investigational Site
Hamburg, Germany, 22149