Status:
COMPLETED
Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or intermediate-acting ...
Eligibility Criteria
Inclusion
- Subjects with type 1 diabetes mellitus more than one year
- Current treatment: basal (once daily at bedtime) - bolus (three times a day just before main meals) regimen only for at least 12 weeks using a long-acting insulin analogue excluding insulin detemir or intermediate-acting insulin as a basal insulin and NovoRapid® as bolus insulin (a brand of basal insulin preparation has not been changed in the preceding 12 weeks)
- HbA1c below 10.0%
- Body Mass Index (BMI) below 30.0 kg/m\^2
Exclusion
- Known hypoglycaemia unawareness or recurrent major hypoglycaemia
- Current treatment with total insulin dose of more than 100 U or IU/day
- Current treatment or expected to start treatment with systemic corticosteroid
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00841087
Start Date
January 1 2009
End Date
May 1 2009
Last Update
March 3 2017
Active Locations (8)
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1
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 103 0002
2
Novo Nordisk Investigational Site
Ebina-shi, Japan, 243 0432
3
Novo Nordisk Investigational Site
Koriyama-shi, Fukushima, Japan, 963 8851
4
Novo Nordisk Investigational Site
Kumamoto-shi,Kumamoto, Japan, 862 0976