Comparison of Human Insulin Produced by the Current Process and the NN729 Process 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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-15

Study Completion Date

2002-12-20

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.

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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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NN729 manufacturing process

Group Type EXPERIMENTAL

human insulin

Intervention Type DRUG

Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)

Current manufacturing process

Group Type ACTIVE_COMPARATOR

human insulin

Intervention Type DRUG

Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)

Interventions

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human insulin

Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
* Fasting blood glucose below or equal to 6 mmol/L
* Body Mass Index (BMI) 22.0-27.0 kg/m\^2 (both inclusive)

Exclusion Criteria

* Participated in another clinical study with an investigational drug within the last 4 weeks
* Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
* Known or suspected allergy to the trial product or related products
* Family history of type 1 diabetes

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes