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

Novo Nordisk A/S40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

Faster-acting insulin aspartDRUG

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).

insulin aspartDRUG

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Neuss, Germany

Outcomes

Primary Outcomes

Area under the serum insulin aspart concentration-time curve

Time frame: From 0 to 1 hour

Secondary Outcomes

Area under the serum insulin aspart concentration-time curve

Time frame: From 0 to 12 hours

Maximum observed serum insulin aspart concentration

Time frame: From 0 to 12 hours

Time to maximum observed serum insulin aspart concentration

Time frame: From 0 to 12 hours

Data from ClinicalTrials.gov

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