Within-subject Variability of Insulin Detemir in Healthy Volunteers
- Registration Number
- NCT01497535
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Healthy Japanese men or women
- Holding a Japanese pass-port and Japanese-born parents
- Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
- Body Mass Index (BMI) between 18 and 30 kg/m^2, incl.
- Fasting blood glucose maximum 6 mmol/L
Exclusion Criteria
- Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
- Any serious systemic infectious disease that occurred during the four weeks prior to the first dose of the trial product, as judged by the Investigator
- Subject with history of alcohol or drug dependence
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin glargine insulin glargine - Insulin detemir insulin detemir -
- Primary Outcome Measures
Name Time Method Maximum glucose infusion rate (GIRmax)
- Secondary Outcome Measures
Name Time Method Area under the glucose infusion rate curve (AUCGIR) Time to maximum glucose infusion rate (tGIRmax) Area under the insulin concentration curve (AUC) Maximum insulin concentration (Cmax) Adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇪Neuss, Germany