A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes
Phase 1
Completed
- Conditions
- Diabetes Mellitus, Type 1Diabetes
- Interventions
- Registration Number
- NCT01618188
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic properties (the effect of the investigated drug on the body) of NN1218 in subjects with type 1 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
- Type 1 diabetes mellitus for more than 12 months
- Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion for more than 12 months
- Body mass index (BMI) between 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 trial start
- 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 substitute products during the inpatient period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Formulation A Faster-acting insulin aspart - Formulation B Faster-acting insulin aspart - Insulin Aspart insulin aspart -
- Primary Outcome Measures
Name Time Method Area under the glucose infusion rate curve From 0 to 2 hours
- Secondary Outcome Measures
Name Time Method Area under the glucose infusion rate curve From 0 to 12 hours Maximum glucose infusion rate Within 0 to 12 hours after dosing Time to maximum glucose infusion rate Within 0 to 12 hours after dosing
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇪Neuss, Germany