Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: insulin aspart
* Drug: insulin aspart


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Insulin aspart 100U/mL<br> | Drug: insulin aspart<br>* An initial priming dose of insulin aspart is administered, then a continuous subcutaneous insulin aspart infusion followed by a bolus of insulin aspart on top of the continuous insulin aspart infusion<br>|
| Experimental: Insulin aspart 200U/mL<br> | Drug: insulin aspart<br>* An initial priming dose of insulin aspart is administered, then a continuous subcutaneous insulin aspart infusion followed by a bolus of insulin aspart on top of the continuous insulin aspart infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |