NCT01487811
Completed
Phase 1
Bioequivalence of Two Biphasic Insulin Aspart 30 (NovoLog® Mix 70/30) Formulations (Current and New Formulation With Glycerol): A Randomized, Double-Blind, Two-Period Crossover Study in Healthy Volunteers
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Area under the concentration curve (AUC) of the two formulations from time 0 hours to infinity
Overview
Brief Summary
This trial is conducted in the United states of America (USA). The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •BMI (body mass index) between 18 and 28 kg/m\^2, both inclusive
- •Subject is a nonsmoker for at least 3 months
- •Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data
- •Fasting plasma glucose between 80 and 110 mg/dl
Exclusion Criteria
- ••Any clinically significant disease history of systemic or organ disease
- ••Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
- ••In females of child bearing potential: Pregnancy, lactating, breastfeeding, intent to become pregnant within the next 6-months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: condom, intrauterine devices). ß-hCG pregnancy test must be negative
Arms & Interventions
Formulation 1
Experimental
Intervention: biphasic insulin aspart 30 (Drug)
Formulation 2
Active Comparator
Intervention: biphasic insulin aspart 30 (Drug)
Outcomes
Primary Outcomes
Area under the concentration curve (AUC) of the two formulations from time 0 hours to infinity
Maximum drug concentration of the two formulations (Cmax)
Secondary Outcomes
- Area under the concentration curve for insulin aspart from time 0 hours to 16 hours
- Mean residence time (MRT)
- Frequency of adverse events
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD TherapyDiabetesDiabetes Mellitus, Type 2NCT00598793Novo Nordisk A/S242
Completed
Phase 4
Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01697631Novo Nordisk A/S131
Completed
Phase 4
Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00600366Novo Nordisk A/S71
Completed
Phase 4
Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00282451Novo Nordisk A/S79
Completed
Phase 3
Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational DiabetesDiabetesGestational DiabetesNCT00065130Novo Nordisk A/S27