A Trial Investigating the Within-subject Variability of NN1250 in Subjects With Type 1 Diabetes
Phase 1
Completed
- Conditions
- Diabetes Mellitus, Type 1Diabetes
- Interventions
- Registration Number
- NCT00961324
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to evaluate the variability in the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- Male or female aged 18-65 years (both inclusive)
- 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
- PARALLEL
- Arm && Interventions
Group Intervention Description IDeg insulin degludec - IGlar insulin glargine -
- Primary Outcome Measures
Name Time Method Area under the glucose infusion rate curve during one dosing interval at steady state 0-24 hours (derived on treatment days 6, 9 and 12)
- Secondary Outcome Measures
Name Time Method Area under the NN1250 concentration-time curve during one dosing interval at steady state 0-24 hours (derived on treatment days 6, 9 and 12)
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇪Neuss, Germany
Novo Nordisk Investigational Site🇩🇪Neuss, Germany