A Trial Investigating the Absolute Bioavailability of Insulin Degludec in Healthy Subjects

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-08-31

Brief Summary

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This trial is conducted in Europe. The aim of the trial is to investigate the absolute bioavailability of insulin degludec (IDeg) in healthy subjects.

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Detailed Description

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Conditions

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Diabetes Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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s.c.

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

A single dose of 0.4 U/kg body weight will be administered subcutaneously (s.c., under the skin).

i.v.

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

A single dose of 0.04 U/kg body weight will be administered intravenously (i.v., into the vein).

Interventions

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insulin degludec

A single dose of 0.4 U/kg body weight will be administered subcutaneously (s.c., under the skin).

Intervention Type DRUG

insulin degludec

A single dose of 0.04 U/kg body weight will be administered intravenously (i.v., into the vein).

Intervention Type DRUG

Other Intervention Names

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IDeg

Eligibility Criteria

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Inclusion Criteria

* Considered generally healthy upon completion of medical history, physical examination, analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
* Body mass index 18.0-27.0 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 gum or transdermal nicotine patches during the inpatient period

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes