A Trial Investigating NN1218 in Subjects With Type 1 and Type 2 Diabetes
Phase 1
Completed
- Conditions
- Diabetes Mellitus, Type 2DiabetesDiabetes Mellitus, Type 1
- Interventions
- Registration Number
- NCT01121276
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 and type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
Inclusion Criteria
- Type 1 or type 2 diabetes mellitus for more than 12 months
- Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for 12 months or longer for subjects with type 1 diabetes and for 3 months or longer for subjects with type 2 diabetes
- Body Mass Index (BMI) between 18.0-32.0 kg/m2 (both inclusive)
Exclusion Criteria
- Surgery or trauma with significant blood loss (more than 500 mL) within the last 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 gum or transdermal nicotine patches during the inpatient period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description NN1218, formulation B Faster-acting insulin aspart - NN1218, formulation C Faster-acting insulin aspart - insulin aspart insulin aspart - NN1218, formulation D Faster-acting insulin aspart - NN1218, formulation A Faster-acting insulin aspart -
- Primary Outcome Measures
Name Time Method Area under the blood glucose concentration-time curve from 0-2 hours
- Secondary Outcome Measures
Name Time Method Area under the blood glucose concentration-time curve from 0-6 hours
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇺🇸Chula Vista, California, United States