A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01455142

Enrollment

Registered

2011-10-19

Start date

2011-10-31

Completion date

2012-01-31

Last updated

2015-02-23

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 Europe. The aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.

Interventions

DRUGinsulin degludec/insulin aspart

Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (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 64 Years

Healthy volunteers

Inclusion criteria

* Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer * Body mass index from 18.0 to 28.0 kg/m\^2 (both inclusive) * HbA1c below or equal to 9.5% by central laboratory analysis

Exclusion criteria

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening * 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 degludec concentration-time curve	From 0 to 120 hours after single-dose (SD)
Maximum observed serum insulin degludec concentration	After single-dose (within 0 to 120 hours after dosing)
Area under the serum insulin aspart concentration-time curve	From 0 to 12 hours after single-dose
Maximum observed serum insulin aspart concentration	After single-dose (within 0 to 12 hours after dosing)

Secondary

Measure	Time frame
Area under the glucose infusion rate curve	From 0 to 26 hours after single-dose
Maximum glucose infusion rate	After single-dose (within 0 to 120 hours after dosing)

Countries

Austria

Outcome results

None listed

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