Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy Volunteers

Bioequivalence of Two Biphasic Insulin Aspart 30 (NovoLog® Mix 70/30) Formulations (Current and New Formulation With Glycerol): A Randomized, Double-Blind, Two-Period Crossover Study in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01487811

Enrollment

Registered

2011-12-07

Start date

2005-05-31

Completion date

2005-11-30

Last updated

2017-01-06

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 the United states of America (USA). The aim of this trial is to compare two formulations of biphasic insulin aspart 30 in healthy volunteers.

Interventions

DRUGbiphasic insulin aspart 30

Single dose administrated subcutaneously (s.c., under the skin)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI (body mass index) between 18 and 28 kg/m\^2, both inclusive * Subject is a nonsmoker for at least 3 months * Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data * Fasting plasma glucose between 80 and 110 mg/dl

Exclusion criteria

* •Any clinically significant disease history of systemic or organ disease * •Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor) * •In females of child bearing potential: Pregnancy, lactating, breastfeeding, intent to become pregnant within the next 6-months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: condom, intrauterine devices). ß-hCG pregnancy test must be negative

Design outcomes

Primary

Measure	Time frame
Area under the concentration curve (AUC) of the two formulations from time 0 hours to infinity	—
Maximum drug concentration of the two formulations (Cmax)	—

Secondary

Measure	Time frame
Area under the concentration curve for insulin aspart from time 0 hours to 16 hours	—
Mean residence time (MRT)	—
Frequency of adverse events	—

Countries

United States

Outcome results

None listed

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