Comparison of Two Insulin Aspart Formulations in Healthy Volunteers

Novo Nordisk A/S24 enrolled

Overview

This trial is conducted in Africa. The aim of this trial is to determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Healthy

Interventions

insulin aspartDRUG

Bolus 0.1 U/kg administered simultaneously with a continuous infusion of 0.029 U/kg/h via a programmed insulin pump. A total dose of 0.35 U/kg is delivered to the subject in the 12 hour infusion

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant * Normal laboratory values, electrocardiogram (ECG), and vital signs unless the investigator considers any abnormality to be clinically irrelevant * Body mass index (BMI) 18-26 kg/m\^2 (both inclusive) * Weight 60-90 kg * Non-smoker Exclusion Criteria: * Any condition requiring the regular use of any medication * Known or suspected allergy to the trial product or related products * Family history of type 1 diabetes mellitus

Locations (1)

Novo Nordisk Investigational Site

Bloemfontein, South Africa

Outcomes

Primary Outcomes

Area under the curve (AUC)

Area under the glucose infusion rate curve

Secondary Outcomes

Cmax (maximum plasma concentration)

Time to reach maximum (tmax)

Terminal half-life (t½)

Incidence of hypoglycemic events

Adverse events

GIRmax: The maximal GIR (glucose infusion rate)

Data from ClinicalTrials.gov

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