Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 Diabetes

A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Investigating the Pharmacokinetics and Pharmacodynamics of NN-X14Mix30 and NN-X14Mix50 in Type 2 Diabetic Patients

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01620424

Enrollment

Registered

2012-06-15

Start date

2001-02-28

Completion date

2001-04-30

Last updated

2017-01-05

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

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief summary

This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of biphasic insulin aspart 30 (NN-X14Mix30) and biphasic insulin aspart 50 (NN-X14Mix5050) in subjects with type 2 diabetes.

Interventions

DRUGbiphasic insulin aspart 30

Single dose administered subcutaneously (s.c., under the skin) on two dosing vists. A wash-out period of 2-28 days will take place between dosing visits

DRUGbiphasic insulin aspart 50

Single dose administered subcutaneously (s.c., under the skin) on two dosing vists. A wash-out period of 2-28 days will take place between dosing visits

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 2 diabetes * Duration of diabetes for at least 1 year * Body Mass Index (BMI) maximum 30.0 kg/m\^2 * HbA1c maximum 10.0%

Exclusion criteria

* Recurrent severe hypoglycaemia * Proliferative or preproliferative retinopathy diagnosed within the last 12 weeks or laser therapy for retinopathy within the last 12 weeks * Impaired hepatic function * Impaired renal function * Cardiac problems * Uncontrolled treated / untreated hypertension * Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive * Total daily insulin dose exceeding 40 IU * Treatment with OHAs (oral hypoglycaemic agents) or insulin preparations twice or more frequently a day * Treatment with OHAs or insulin preparations once a day later than noon * Subjects who smoke more than 15 cigarettes per day

Design outcomes

Primary

Measure	Time frame
The maximum insulin aspart concentration	—

Secondary

Measure	Time frame
tmax, the time to maximum insulin aspart concentration	—
t½, terminal half-life	—
The area under the glucose infusion rate (GIR) profile	—
GIRmax, maximum glucose infusion rate value	—
The area under the insulin aspart curve	—
The area under the glucose infusion rate profile	—
Vital signs (blood pressure and pulse)	—
Adverse events	—
tmaxGIR, time to maximum glucose infusion rate value	—

Countries

Japan

Outcome results

None listed

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