Status:
COMPLETED
A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Japan. The aim of this clinical trial is to investigate the effect of NN1250 (insulin degludec) in Japanese subjects with type 1 diabetes.
Eligibility Criteria
Inclusion
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
- Current daily basal insulin requirement above or equal to 0.3 (I)U/kg/day
- Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0% (one retest within a week is permitted with the result of the last test being conclusive)
Exclusion
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period (only clamp period)
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01135927
Start Date
June 1 2010
End Date
October 1 2010
Last Update
January 20 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Tokyo, Japan, 130-0004