Status:
COMPLETED
Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects 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
This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insuli...
Eligibility Criteria
Inclusion
- Type 1 diabetes for at least 12 months
- Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months
- BMI below or equal to 35 kg/m\^2
- HbA1c below or equal to 12%
Exclusion
- Proliferative retinopathy or maculopathy requiring acute treatment
- Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator)
- Subjects with known hypoglycaemic unawareness as judged by the Investigator
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2002
Estimated Enrollment :
598 Patients enrolled
Trial Details
Trial ID
NCT01486940
Start Date
March 1 2002
End Date
October 1 2002
Last Update
January 27 2017
Active Locations (75)
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1
Novo Nordisk Investigational Site
Junín, Argentina
2
Novo Nordisk Investigational Site
Morón, Argentina
3
Novo Nordisk Investigational Site
Varaždin, Croatia, 42 000
4
Novo Nordisk Investigational Site
Hradec Králové, Czechia, 50036