Investigation of the Response Relationship of NN5401 in Type 1 Diabetics

A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 1 Diabetes

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00993096

Enrollment

Registered

2009-10-09

Start date

2009-09-30

Completion date

2009-12-31

Last updated

2017-02-10

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 was conducted in Europe. The aim of this clinical trial was to evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes. The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.

Interventions

DRUGinsulin degludec/insulin aspart

Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)

DRUGbiphasic insulin aspart 30

Single dose of 0.4 U/kg body weight injected 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 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) * Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic * 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 (AUC) under the glucose infusion rate curve	From 0 to 24 hours after single-dose administration

Secondary

Measure	Time frame
Area (AUC) under the insulin aspart concentration time curve	From 0 to 24 hours after single-dose administration

Countries

Germany

Outcome results

None listed

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