Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes
- Registration Number
- NCT01076634
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects with type 1 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index 18.0-28.0 kg/m^2 (both inclusive)
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description IDeg 100 U/mL insulin degludec - IDeg 200 U/mL insulin degludec -
- Primary Outcome Measures
Name Time Method Area under the glucose infusion rate curve during one dosing interval at steady-date" After 8 days of treatment
- Secondary Outcome Measures
Name Time Method Area under the serum Insulin Degludec concentration-time curve From 0 to 24 hours after single dose
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇦🇹Graz, Austria