Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process

A Single Centre, Randomized, Balanced Double Blind, Cross-Over Trial Investigating the Bioequivalence of NovoRapid® Produced by the Current Process and Insulin Aspart With the Same Formulation as NovoRapid®, Produced by the NN2000 Process

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01486914

Enrollment

Registered

2011-12-07

Start date

2003-01-19

Completion date

2003-02-24

Last updated

2017-03-01

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 compare insulin aspart produced by current process and the NN2000 process.

Interventions

DRUGinsulin aspart

Single dose of each formulation administrated subcutaneously (s.c., under the skin) at two separate dosing visits

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

Inclusion criteria

* Healthy * Caucasian * Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant * Fasting blood glucose below or equal to 6 mmol/L * Body mass index (BMI) 22.0-27.0 kg/m\^2 (both inclusive)

Exclusion criteria

* Participated in another clinical study with an investigational drug within the last 4 weeks * Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable * Known or suspected allergy to the trial product or related products * Family history of type 2 diabetes

Design outcomes

Primary

Measure	Time frame
Area under the Curve (AUC) (insulin aspart)	—

Secondary

Measure	Time frame
Cmax (maximum plasma concentration)	—
Terminal half life (t½)	—
Incident of hypoglycaemic episodes	—
Adverse events	—

Countries

United Kingdom

Outcome results

None listed

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