Effect of NN5401 in Japanese 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

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-04-30

Brief Summary

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This trial is conducted in Japan. The aim of this clinical trial is to investigate the blood sugar lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in Japanese subjects with type 1 diabetes. Each subject will be randomised to one of the two possible treatment sequences (NN5401 followed by biphasic insulin aspart (BIAsp) 30 or biphasic insulin aspart 30 followed by NN5401).

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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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IDegAsp

Group Type EXPERIMENTAL

insulin degludec/insulin aspart

Intervention Type DRUG

Single dose of 0.5 U/kg body weight injected s.c. (under the skin)

BIAsp 30

Group Type ACTIVE_COMPARATOR

biphasic insulin aspart 30

Intervention Type DRUG

Single dose of 0.5 U/kg body weight injected s.c. (under the skin)

Interventions

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insulin degludec/insulin aspart

Single dose of 0.5 U/kg body weight injected s.c. (under the skin)

Intervention Type DRUG

biphasic insulin aspart 30

Single dose of 0.5 U/kg body weight injected s.c. (under the skin)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Japanese subject
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index (BMI): 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria

* Loss of more than 400 mL blood (inclusive) in total with in the last 12 weeks or more than 200 mL blood (inclusive) in total within the last 4 weeks prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes (not inclusive 5) 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

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No