Comparison of Biphasic Insulin Aspart Produced by the NN2000 Process to Current Process to in Type 2 Diabetes

A 24-week, Randomised, Multi-centre, Double-blind, Parallel-group Trial to Investigate the Safety and the Efficacy of NN2000-Mix30 Compared to NN-X14Mix30 NovoRapid®30Mix) in Subjects With Type 2 Diabetes Mellitus on a Twice Daily Regimen

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00564668

Enrollment

126

Registered

2007-11-28

Start date

2004-06-19

Completion date

2005-04-12

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, Diabetes Mellitus, Type 2

Brief summary

This trial is conducted in Japan. The aim of this trial was to investigate the safety and efficacy of NN2000-Mix30 produced by NN2000 process compared to that of NN-X14Mix30 produced by current process in Japanese subjects with type 2 diabetes.

Interventions

DRUGbiphasic insulin aspart

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects with type 2 diabetes * Subjects with insulin treatment for at least 24 weeks * Current treatment with premixed biphasic human insulin preparation for at least 12 weeks * HbA1c lesser than or equal to 11.0%

Exclusion criteria

* Recurrent severe hypoglycaemia * Proliferative retinopathy or maculopathy requiring acute treatment * Impaired renal function * Cardiac diseases * Uncontrolled hypertension * Subjects with known malignant tumour * Total daily insulin dose greater than or equal to 100 IU

Design outcomes

Primary

Measure	Time frame
Safety	During 24 weeks of treatment

Secondary

Measure	Time frame
HbA1c	—

Countries

Japan

Outcome results

None listed

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