Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers

Novo Nordisk A/S24 enrolled

Overview

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin 30/70 PreMix in healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Healthy

Interventions

biphasic insulin aspart 30DRUG

One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

biphasic human insulin 30DRUG

One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Non-smokers * BMI (body mass index) maximum 27 kg/m\^2 * HbA1c (glycosylated haemoglobin A1c): 3.4-6.1% * FBG (fasting blood glucose) maximum 6.0 mmol/L

Locations (1)

Novo Nordisk Investigational Site

Leeds, United Kingdom

Outcomes

Primary Outcomes

Area under the Curve

Secondary Outcomes

Maximum insulin concentration (Cmax)

Time to maximum insulin concentration (tmax)

Minimum glucose concentration (Cmin(glu))

Time to minimum glucose concentration (tmin(glu))

Adverse events

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.