Status:
COMPLETED
Comparison of Insulin Detemir and Insulin Semilente®MC in Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
12-18 years
Phase:
PHASE3
Brief Summary
This trial is conducted in Europe. A 32-week efficacy and safety comparison of insulin detemir and insulin semilente MC in children between 6 and 21 years with type 1 diabetes.
Eligibility Criteria
Inclusion
- Type 1 diabetes
- Current intensified insulin treatment
- Injection of insulin Semilente®MC at bedtime for at least 6 weeks
- BMI maximum 32 kg/m\^2
- HbA1c \> 5.5 % and \< 12.0 %
Exclusion
- Current treatment with premixed insulin(s)
- Impaired hepatic or renal function
- Recurrent major hypoglycaemia
Key Trial Info
Start Date :
August 16 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2005
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00184639
Start Date
August 16 2004
End Date
November 22 2005
Last Update
February 24 2017
Active Locations (2)
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1
Novo Nordisk Investigational Site
Berlin, Germany, 13353
2
Novo Nordisk Investigational Site
Hanover, Germany, 30173