A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 1 Diabetes
Phase 1
Completed
- Conditions
- Diabetes Mellitus, Type 1Diabetes
- Interventions
- Registration Number
- NCT01135927
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- 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 Criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A insulin degludec - B insulin detemir -
- Primary Outcome Measures
Name Time Method Area under the NN1250 GIR (glucose infusion rate) curve During one dosing interval at steady state
- Secondary Outcome Measures
Name Time Method Area under the serum insulin detemir concentration-time curve During one dosing interval at steady state
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇯🇵Tokyo, Japan