Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers

A Randomised, Double-blind 2 Way Crossover Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Insulin X14 30/70 PreMix Compared to Human Insulin 30/70 PreMix in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01707160

Enrollment

Registered

2012-10-16

Start date

1995-11-30

Completion date

1995-12-31

Last updated

2017-01-04

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 investigate the pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin 30/70 PreMix in healthy volunteers.

Interventions

DRUGbiphasic insulin aspart 30

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

DRUGbiphasic human insulin 30

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Area under the Curve	—

Secondary

Measure	Time frame
Maximum insulin concentration (Cmax)	—
Time to maximum insulin concentration (tmax)	—
Minimum glucose concentration (Cmin(glu))	—
Time to minimum glucose concentration (tmin(glu))	—
Adverse events	—

Countries

United Kingdom

Outcome results

None listed

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