Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-11-30

Brief Summary

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This trial is conducted in the United states of America (USA). The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.

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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

DOUBLE

Participants Investigators

Study Groups

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Formulation 1

Group Type EXPERIMENTAL

biphasic insulin aspart 30

Intervention Type DRUG

Single dose administrated subcutaneously (s.c., under the skin)

Formulation 2

Group Type ACTIVE_COMPARATOR

biphasic insulin aspart 30

Intervention Type DRUG

Single dose administrated subcutaneously (s.c., under the skin)

Interventions

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biphasic insulin aspart 30

Single dose administrated subcutaneously (s.c., under the skin)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI (body mass index) between 18 and 28 kg/m\^2, both inclusive
* Subject is a nonsmoker for at least 3 months
* Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data
* Fasting plasma glucose between 80 and 110 mg/dl

Exclusion Criteria

* •Any clinically significant disease history of systemic or organ disease
* •Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor)
* •In females of child bearing potential: Pregnancy, lactating, breastfeeding, intent to become pregnant within the next 6-months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: condom, intrauterine devices). ß-hCG pregnancy test must be negative

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes