Within-subject Variability of Insulin Detemir in Healthy Volunteers

Novo Nordisk A/S40 enrolled

Overview

This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Healthy

Interventions

insulin detemirDRUG

On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)

insulin glargineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Japanese men or women * Holding a Japanese pass-port and Japanese-born parents * Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator * Body Mass Index (BMI) between 18 and 30 kg/m\^2, incl. * Fasting blood glucose maximum 6 mmol/L Exclusion Criteria: * Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator * Any serious systemic infectious disease that occurred during the four weeks prior to the first dose of the trial product, as judged by the Investigator * Subject with history of alcohol or drug dependence

Locations (1)

Novo Nordisk Investigational Site

Neuss, Germany

Outcomes

Primary Outcomes

Maximum glucose infusion rate (GIRmax)

Secondary Outcomes

Area under the glucose infusion rate curve (AUCGIR)

Time to maximum glucose infusion rate (tGIRmax)

Area under the insulin concentration curve (AUC)

Maximum insulin concentration (Cmax)

Adverse events

Data from ClinicalTrials.gov

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