Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Healthy Volunteers
- Registration Number
- NCT01448070
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 28
Inclusion Criteria
- Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
- Fasting blood glucose below or equal to 6 mmol/L
- Body Mass Index (BMI) 22.0-27.0 kg/m^2 (both inclusive)
Exclusion Criteria
- Participated in another clinical study with an investigational drug within the last 4 weeks
- Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
- Known or suspected allergy to the trial product or related products
- Family history of type 1 diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Current manufacturing process human insulin - NN729 manufacturing process human insulin -
- Primary Outcome Measures
Name Time Method Cmax (maximum plasma concentration) Area under the curve (glucose infusion rate (GIR)), 0-8h AUC (area under the curve) 0-8h (human insulin)
- Secondary Outcome Measures
Name Time Method tmax (time to reach maximum) t½ (terminal half-life) GIR (glucose infusion rate) max tGIR (glucose infusion rate) max Area under the curve (C-peptide, 0-8h) Physical examinations and vital signs
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧Manchester, United Kingdom