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.
Drug: insulin aspart
Drug: insulin aspart
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Locations near you
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Full eligibility criteria for NCT01464099
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT01464099
United States (1)
Novo Nordisk Clinical Trial Call Center
Chula Vista, California, United States, 91911
View full eligibility
Tris trial is registered with FDA with number: NCT01464099. The sponsor of the trial is Novo Nordisk A/S and it is looking for 24 volunteers for the current phase.
Official trial title: A Single Center, Randomized, Double-blind, Balanced Two-period Cross-over Trial to Test for Bioequivalence Between a Marketed NovoLog® Formulation Containing 100 U/mL Versus a New NovoLog® Formulation Containing 200 U/mL in a Combined Regimen of a Continuous Subcutaneous Infusion and a Meal-time Bolus in Subjects With Type 1 Diabetes
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