Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Type 1 Diabetics

A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties Between NN5401 and NN1250 and Between NN5401 and Insulin Aspart in Subjects With Type 1 Diabetes

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00992537

Enrollment

Registered

2009-10-09

Start date

2009-10-31

Completion date

2010-01-31

Last updated

2013-11-27

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 this clinical trial is to compare the blood glucose lowering effect of NN5401(insulin degludec/insulin aspart (IDegAsp)) with NN1250 (insulin degludec (IDeg)) and insulin aspart (IAsp) in subjects with type 1 diabetes where the trial participant will receive one single dose of each trial product in varying order.

Interventions

DRUGinsulin degludec

Insulin degludec single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).

DRUGinsulin degludec/insulin aspart

Insulin degludec/insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).

DRUGinsulin aspart

Insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * Body mass index 18.0-28.0 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 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 glucose infusion rate curve	From 0 to 6 hours after single-dose administration

Secondary

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

Countries

Germany

Outcome results

None listed

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