Comparison of Two Insulin Detemir Formulations in Healthy Volunteers
- Registration Number
- NCT01498926
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare two formulations of insulin detemir containing an isotonic agent in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
- Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
- Body mass index (BMI) between 18 and 27 kg/m^2, inclusive
- Non-smoker
- Fasting plasma glucose maximum 6 mmol/L
Exclusion Criteria
- Known or suspected allergy to trial products or related products
- Previous participation in this trial
- 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)
- The receipt of any investigational drug within the last 3 months prior to this trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Glycerol insulin detemir - Mannitol insulin detemir -
- Primary Outcome Measures
Name Time Method Area under the serum insulin detemir concentration curve Maximum serum insulin concentration
- Secondary Outcome Measures
Name Time Method Time to maximum serum insulin concentration Terminal serum insulin half life Area under the serum insulin detemir concentration curve Maximum glucose infusion rate Time to maximum glucose infusion rate Area under the glucose infusion rate curve Adverse events