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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01590836

Enrollment

Registered

2012-05-03

Start date

2012-04-30

Completion date

2012-06-30

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 is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic response (the effect of the investigated drug on the body) of insulin degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes.

Interventions

DRUGinsulin degludec

Administered subcutaneously (s.c., under the skin) once daily (plus insulin aspart as bolus insulin as required).

DRUGinsulin degludec/insulin aspart

Single dose administered subcutaneously (s.c., under the skin).

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

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 * Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months * Body mass index (BMI) 18.0-28.0 kg/m\^2 (both inclusive) * Glycosylated haemoglobin (HbA1c) maximum 9.5 % * Fasting C-peptide maximum 0.3 nmol/L

Exclusion criteria

* 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, use of nicotine gum or transdermal nicotine patches during the inpatient period * Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening * Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening

Design outcomes

Primary

Measure	Time frame
Area under the glucose infusion rate curve during one dosing interval	At steady state (0-24 hours)

Secondary

Measure	Time frame
Maximum glucose infusion rate (GIRmax)	At steady state (within 0-24 hours after last dosing)
Area under the serum insulin degludec concentration-time curve during one dosing interval	At steady state (within 0-24 hours after last dosing)
Maximum observed serum insulin degludec concentration	At steady state (within 0-24 hours after last dosing)
Area under the serum insulin aspart concentration-time curve	From 0 to 12 hours
Maximum observed serum insulin aspart concentration	Within 0-12 hours after dosing of IDegAsp

Countries

Germany

Outcome results

None listed

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