Comparison of Two NN1250 Formulations in Healthy Volunteers
- Registration Number
- NCT00966368
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial was conducted in North America. The aim of this clinical trial was to investigate if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the body.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- Considered generally healthy upon completion of medical history, physical examination, vital signs and ECG (electrocardiogram), as judged by the Investigator
- Body mass index 18.0-27.0 kg/m^2 (both inclusive)
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description IDeg E insulin degludec - IDeg M insulin degludec -
- Primary Outcome Measures
Name Time Method Maximum observed Insulin Degludec concentration after single dose From 0 to 120 hours after dosing Area under the Insulin Degludec concentration-time curve from 0 to 120 hours after single dose From 0 to 120 hours after dosing
- Secondary Outcome Measures
Name Time Method Time to maximum observed Insulin Degludec concentration after single dose From 0 to 120 hours after dosing Area under the Insulin Degludec concentration-time curve from 0 to 24 hours after single dose From 0-24 hours after dosing Terminal half-life for Insulin Degludec From 0 to 120 hours after dosing
Trial Locations
- Locations (1)
Novo Nordisk Clinical Trial Call Center
🇺🇸Chula Vista, California, United States