Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes

Comparison of Efficacy and Safety of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00569400

Enrollment

241

Registered

2007-12-07

Start date

2003-05-01

Completion date

2004-01-19

Last updated

2017-02-27

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 Asia and Oceania. The aim of this trial is to compare the efficacy and safety of human insulin produced by the current process and the NN729 process in type 1 diabetes.

Interventions

DRUGhuman insulin

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

* Duration of diabetes for at least 12 months * Basal/bolus treatment with human insulin for at least 2 months preceding trial start * Body Mass Index (BMI) lesser than or equal to 35.0 kg/m2 * HbA1c lesser than or equal to 12.0%

Exclusion criteria

* Proliferative retinopathy or maculopathy requiring acute treatment or laser treatment within the last 6 months * Any condition that the investigator and/or sponsor feel would interfere with trial participation * Known or suspected allergy against trial product or related products

Design outcomes

Primary

Measure	Time frame
Change of human insulin antibodies	after 26 weeks of treatment

Secondary

Measure	Time frame
Change of human insulin antibodies	—
Frequency of adverse events	—

Countries

Australia, Hong Kong, Malaysia, Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026