Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy Subjects
- Registration Number
- NCT01490099
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence between insulin detemir produced by the NN729 process and by the current process in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
- Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
- Body mass index (BMI) between 18.0 and 27.0 kg/m^2, inclusive
- Non-smoker
- Fasting plasma glucose (FPG) maximum 6.0 mmol/L
Exclusion Criteria
- Known or suspected allergy to trial products or related products
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant)
- A history of alcohol or drug abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment period 2 insulin detemir - Treatment period 1 insulin detemir -
- Primary Outcome Measures
Name Time Method AUC0-36h, area under the serum insulin detemir concentration curve From 0 to 36 hours Cmax, maximum serum insulin detemir concentration
- Secondary Outcome Measures
Name Time Method AUC, area under the serum insulin detemir concentration curve Time to maximum concentration (tmax) Terminal half life (t½) Area under the Curve Glucose Infusion Rate (AUCGIR) Adverse events