Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Healthy Volunteers

Novo Nordisk A/S28 enrolled

Overview

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®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Healthy

Interventions

human insulinDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Manchester, United Kingdom

Outcomes

Primary Outcomes

AUC (area under the curve) 0-8h (human insulin)

Cmax (maximum plasma concentration)

Area under the curve (glucose infusion rate (GIR)), 0-8h

Secondary Outcomes

tmax (time to reach maximum)

t½ (terminal half-life)

GIR (glucose infusion rate) max

tGIR (glucose infusion rate) max

Area under the curve (C-peptide, 0-8h)

Physical examinations and vital signs

Data from ClinicalTrials.gov

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