A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01469143

Enrollment

Registered

2011-11-10

Start date

2011-11-30

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 purpose of this trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of different formulations of NN1218.

Interventions

DRUGFaster-acting insulin aspart

Each subject will randomly be allocated to a treatment sequence consisting of 9 dosing visits during which the subject will receive 8 single doses of different formulations. For all investigational medicinal products the dose levels will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).

DRUGinsulin aspart

At one of the scheduled visits, the subject will receive a single dose of insulin aspart. The dose level will be 0.2 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 for more than 12 months * Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months * Body mass index (BMI) between 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion criteria

* Subjects 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 1 hour

Secondary

Measure	Time frame
Area under the serum insulin aspart concentration-time curve	From 0 to 12 hours
Maximum observed serum insulin aspart concentration	From 0 to 12 hours
Time to maximum observed serum insulin aspart concentration	From 0 to 12 hours

Countries

Germany

Outcome results

None listed

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