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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01464099

Enrollment

Registered

2011-11-03

Start date

2008-06-30

Completion date

2008-11-30

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1

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.

Interventions

DRUGinsulin aspart

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026