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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

241

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started May 2003

Shorter than P25 for phase_3 diabetes

Geographic Reach

4 countries

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

9 months study duration

Study Start

First participant enrolled

May 1, 2003

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2004

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2004

Completed

3.9 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2007

Completed

Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

December 5, 2007

Last Update Submit

February 23, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Change of human insulin antibodies
after 26 weeks of treatment

Secondary Outcomes (2)

Change of human insulin antibodies
Frequency of adverse events

Interventions

human insulinDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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%

You may not qualify if:

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

Contact the study team to confirm eligibility.