Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes

A Six Months, Multi-centre, Open, Randomised, Parallel Safety and Efficacy Comparison of NovoRapid® Produced by the Current Process and Insulin Aspart With the Same Formulation as NovoRapid®, Produced by the NN2000 Process in Subjects With Type 1 Diabetes on a Basal/Bolus Regimen

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00604656

Enrollment

241

Registered

2008-01-30

Start date

2003-05-05

Completion date

2004-01-29

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 1

Brief summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety and efficacy of insulin aspart produced by current process compared to that of insulin aspart produced by NN2000 process in subjects with type 2 diabetes.

Interventions

DRUGinsulin aspart

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects with type 1 diabetes * Duration of diabetes for at least 12 months * Treatment with insulin aspart for at least 3 months before trial start * Body Mass Index (BMI) below 35.0 kg/m2 * HbA1c below 12.0%

Exclusion criteria

* Total insulin dosage more than 1.4 IU/kg/day * Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator) * Known hypoglycaemia unawareness as judged by the investigator * Known hypersensitivity or allergy

Design outcomes

Primary

Measure	Time frame
Insulin aspart antibodies	After 6 months treatment

Secondary

Measure	Time frame
Occurrence of adverse events	—
Incidence of hypoglycaemic episodes	—
HbA1c	—

Countries

Czechia, Germany, Hungary, Italy, Poland

Outcome results

None listed

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