A Comparison Between Two Formulations of NN5401 in Healthy Subjects

A Trial to Test for Bioequivalence Between Two NN5401 Formulations in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01125553

Enrollment

Registered

2010-05-18

Start date

2010-05-31

Completion date

2010-08-31

Last updated

2015-09-25

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

Conditions

Diabetes, Healthy

Brief summary

This trial is conducted in the United States of America (USA). The aim of the trial is to compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in healthy subjects.

Interventions

DRUGinsulin degludec/insulin aspart

Each subject will be allocated to two single injections of trial product on two separate dosing visits with each of the two insulin degludec/insulin aspart formulations. The trial products will be administered as a subcutaneous injection (under the skin).

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the physician * Body mass index between 18.0 and 27.0 kg/m\^2 (both inclusive)

Exclusion criteria

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start * Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Design outcomes

Primary

Measure	Time frame
Area under the serum insulin aspart concentration-time curve	from 0 to 12 hours after single-dose
Maximum observed serum insulin aspart concentration	from 0 to 12 hours after single-dose
Area under the serum insulin degludec concentration-time curve	from 0 to 120 hours after single-dose
Maximum observed serum insulin degludec concentration	from 0 to 120 hours after single-dose

Secondary

Measure	Time frame
Time to maximum observed serum insulin degludec concentration	from 0 to 120 hours after single-dose
Time to maximum observed serum insulin aspart concentration	from 0 to 12 hours after single-dose

Countries

United States

Outcome results

None listed

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