Bioequivalence of Two Insulin Aspart Formulations (100 U/mL Versus 200 U/mL)

A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial, Assessing the Bioequivalence Between Insulin Aspart 100 U/mL and Insulin Aspart 200 U/mL in Healthy Individuals

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01530048

Enrollment

Registered

2012-02-09

Start date

2006-03-31

Completion date

2006-05-31

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

Brief summary

This trial is conducted in Europe. The aim of this trial is to test if there is bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin aspart 200 U/mL (U200) formulation.

Interventions

DRUGinsulin aspart

A single bolus injection of 0.2 U/kg administered subcutaneously (s.c., under the skin) on two separate dosing visits with a wash-out period 2-15 days in-between

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Considered to be healthy as judged from vital signs, medical history, ECG (electrocardiogram), laboratory values, and physical examination * Body mass index between 18 and 27 kg/m\^2 (both inclusive) * Non-smoker * Fasting blood glucose maximum 6 mmol/L * HbA1c below 6.4%

Exclusion criteria

* Pregnant or breast-feeding women * Women not using acceptable methods of contraception without difficulties for at least three months prior to trial start (screening), including intrauterine devices, oral contraceptives, hormonal implants, or sterilisation * Clinically significant abnormal laboratory values (as judged by the Investigator) * Close relative with type 1 diabetes mellitus (father, mother, sister or brother) * Intake of alcohol within the last 24 hours prior to screening and drug administration visits * Blood donation or blood loss of more than 500 mL within the 3 last months before screening * Strenuous exercise within 48 hours before screening as well as drug administration and followup * Smoking during the past month before drug administration

Design outcomes

Primary

Measure	Time frame
Area under the curve (AUC) in the interval of 0-6 hours	—
Cmax, maximum concentration	—

Secondary

Measure	Time frame
AUC in the interval of 0-infinity hours	—
tmax, time to reach Cmax	—
Terminal rate constant	—
tGIRmax, time to maximum glucose infusion rate value	—
t½, terminal half-life	—
AUCGIR, area under the glucose infusion rate value curve	—
GIRmax, maximum glucose infusion rate value	—
Vz/f, volume of distribution during terminal phase	—
Adverse events	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026