Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes
- Registration Number
- NCT01464099
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the clinical performance of two formulations of insulin aspart (NovoLog®) in subjects with type 1 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Subjects with type 1 diabetes treated with insulin for at least 12 months
- BMI (Body Mass Index) between 18.0-29.0 kg/m^2
- Negative fasting C-peptide (below or equal to 0.6 ng/mL)
- HbA1c (glycosylated haemoglobin A1c) below or equal to 10.0%
- Current treatment with insulin below or equal to 1.2 U/kg/day
- Subject should be in good health based on medical history, physical examination and routine laboratory data
Exclusion Criteria
- Any known/suspected allergies to trial medication or similar products/devices
- A subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
- Clinically significant active disease of any kind
- Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator
- Blood donation (more than 500 mL) within the previous 9 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Insulin aspart 100U/mL insulin aspart - Insulin aspart 200U/mL insulin aspart -
- Primary Outcome Measures
Name Time Method Area under the insulin aspart bolus concentration-time curve From 0 and up to 12 hours post bolus dose administration Maximum plasma concentration (Cmax) of insulin aspart From 0 and up to 12 hours post bolus dose administration
- Secondary Outcome Measures
Name Time Method Time to maximum concentration (Tmax) of insulin aspart From 0-12 hours post bolus dose administration AUC (area under the curve) of insulin aspart From -4 to 0 hours after dose administration
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇺🇸Chula Vista, California, United States