Status:
COMPLETED
Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in 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 the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargi...
Eligibility Criteria
Inclusion
- Type 1 diabetes for at least 12 months
- Current treatment with basal-bolus insulin regimen for more than or equal to 3 months
- HbA1c less than or equal to 11.0%
Exclusion
- Proliferative retinopathy or maculopathy
- Recurrent major hypoglycaemia
- Impaired hepatic or renal function
- Cardiac problems or uncontrolled hypertension
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
447 Patients enrolled
Trial Details
Trial ID
NCT00095082
Start Date
September 1 2004
End Date
December 1 2005
Last Update
January 27 2017
Active Locations (81)
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1
Novo Nordisk Investigational Site
Anaheim, California, United States, 92801
2
Novo Nordisk Investigational Site
Huntington Beach, California, United States, 92646
3
Novo Nordisk Investigational Site
Inglewood, California, United States, 90301
4
Novo Nordisk Investigational Site
Irvine, California, United States, 92618