Comparison of Two Insulin Aspart Formulations in Healthy Volunteers
- Registration Number
- NCT01698697
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Africa. The aim of this trial is to determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
- Normal laboratory values, electrocardiogram (ECG), and vital signs unless the investigator considers any abnormality to be clinically irrelevant
- Body mass index (BMI) 18-26 kg/m^2 (both inclusive)
- Weight 60-90 kg
- Non-smoker
Exclusion Criteria
- Any condition requiring the regular use of any medication
- Known or suspected allergy to the trial product or related products
- Family history of type 1 diabetes mellitus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description U100 insulin aspart - U200 insulin aspart -
- Primary Outcome Measures
Name Time Method Area under the curve (AUC) Area under the glucose infusion rate curve
- Secondary Outcome Measures
Name Time Method Cmax (maximum plasma concentration) Time to reach maximum (tmax) Terminal half-life (t½) Incidence of hypoglycemic events Adverse events GIRmax: The maximal GIR (glucose infusion rate)
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇿🇦Bloemfontein, South Africa