Bioequivalence of Two Insulin Aspart Formulations (100 U/mL Versus 200 U/mL)
- Registration Number
- NCT01530048
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to test if there is bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin aspart 200 U/mL (U200) formulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
- Considered to be healthy as judged from vital signs, medical history, ECG (electrocardiogram), laboratory values, and physical examination
- Body mass index between 18 and 27 kg/m^2 (both inclusive)
- Non-smoker
- Fasting blood glucose maximum 6 mmol/L
- HbA1c below 6.4%
Exclusion Criteria
- Pregnant or breast-feeding women
- Women not using acceptable methods of contraception without difficulties for at least three months prior to trial start (screening), including intrauterine devices, oral contraceptives, hormonal implants, or sterilisation
- Clinically significant abnormal laboratory values (as judged by the Investigator)
- Close relative with type 1 diabetes mellitus (father, mother, sister or brother)
- Intake of alcohol within the last 24 hours prior to screening and drug administration visits
- Blood donation or blood loss of more than 500 mL within the 3 last months before screening
- Strenuous exercise within 48 hours before screening as well as drug administration and followup
- Smoking during the past month before drug administration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description U200 insulin aspart - U100 insulin aspart -
- Primary Outcome Measures
Name Time Method Cmax, maximum concentration Area under the curve (AUC) in the interval of 0-6 hours
- Secondary Outcome Measures
Name Time Method Vz/f, volume of distribution during terminal phase GIRmax, maximum glucose infusion rate value tGIRmax, time to maximum glucose infusion rate value AUC in the interval of 0-infinity hours tmax, time to reach Cmax Terminal rate constant t½, terminal half-life AUCGIR, area under the glucose infusion rate value curve Adverse events
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of insulin aspart U100 and U200 in glucose regulation and receptor signaling?
How does the efficacy of U200 compare to standard U100 insulin aspart in managing postprandial hyperglycemia in type 1 diabetes?
What biomarkers correlate with bioequivalence outcomes in insulin aspart formulation trials involving healthy volunteers?
What are the potential adverse events associated with high-concentration U200 insulin aspart and how do they differ from U100?
How do U200 insulin aspart formulations compare to other rapid-acting insulins like lispro or glulisine in terms of pharmacokinetics and patient outcomes?
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇰Hvidovre, Denmark
Novo Nordisk Investigational Site🇩🇰Hvidovre, Denmark