Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of insulin aspart compared to soluble human insulin on blood glucose control in children below 7 years of age with type 1 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline

Completed

Started Aug 2003

Geographic Reach

1 country

5 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

1.2 years study duration

Study Start

First participant enrolled

August 1, 2003

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed

3.2 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2007

Completed

Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

December 11, 2007

Last Update Submit

December 20, 2016

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

HbA1c
after 26 weeks of treatment

Secondary Outcomes (5)

Overall glycaemic control
Occurrence of adverse events
Occurrence of serious adverse events
Frequency of hypoglycaemia episodes
Quality of Life (QoL)

Interventions

insulin aspartDRUG

soluble human insulinDRUG

Eligibility Criteria

AgeUp to 7 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Type 1 diabetes for at least 1 year
HbA1c below 12.0%
Treatment with regular human insulin and insulin NPH for at least 1 month
Receive more than 2 injections daily

You may not qualify if:

Receipt of investigational product within 6 months prior to trial participation
Known or suspected allergy to investigational product
Receipt of of insulin aspart within 3 months prior to trial participation

Contact the study team to confirm eligibility.