A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Subjects With Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-11-30

Brief Summary

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This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) in subjects with type 1 diabetes.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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FIASP

Each treatment period consists of 1 dosing visit during which the subject will receive a single dose of either insulin aspart or FIAsp at a predefined fixed dose level (in random sequence) in connection to intake of a standardised meal.

Group Type EXPERIMENTAL

Faster-acting insulin aspart

Intervention Type DRUG

A single dose will be administered subcutaneously (under the skin) in the abdomen.

Each subject will be allocated to two treatment periods separated by a wash-out period of 3-12 days.

NovoRapid®

Each treatment period consists of 1 dosing visit during which the subject will receive a single dose of either insulin aspart or FIAsp at a predefined fixed dose level (in random sequence) in connection to intake of a standardised meal.

Group Type ACTIVE_COMPARATOR

insulin aspart

Intervention Type DRUG

A single dose will be administered subcutaneously (under the skin)) in the abdomen.

Each subject will be allocated to two treatment periods separated by a wash-out period of 3-12 days.

Interventions

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Faster-acting insulin aspart

A single dose will be administered subcutaneously (under the skin) in the abdomen.

Each subject will be allocated to two treatment periods separated by a wash-out period of 3-12 days.

Intervention Type DRUG

insulin aspart

A single dose will be administered subcutaneously (under the skin)) in the abdomen.

Each subject will be allocated to two treatment periods separated by a wash-out period of 3-12 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.5-28.0 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 substitute products during the inpatient period inpatient period

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No