NCT01538576

Brief Summary

This study is conducted in Japan. The aim of this study is to collect safety and efficacy data when using insulin aspart in children with diabetes under normal clinical practice conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
Last Updated

March 7, 2016

Status Verified

March 1, 2016

Enrollment Period

5.8 years

First QC Date

February 15, 2012

Last Update Submit

March 3, 2016

Conditions

DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control

    Year 1

  • HbA1c (glycosylated haemoglobin)

    Year 1

Secondary Outcomes (2)

  • Hypoglycaemic events

    Year 1

  • Adverse Events

    Year 1

Study Arms (1)

Insulin aspart users

Drug: insulin aspart

Interventions

insulin aspartDRUG

Prescribed by the physicians as a result of normal clinical practice

Insulin aspart users

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients under 15 years of age with diabetes requiring insulin therapy with no treatment history of insulin aspart (NovoRapid®)

You may qualify if:

  • Subjects with diabetes requiring insulin therapy

You may not qualify if:

  • Subjects who had treatment history of insulin aspart

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, 1000005, Japan

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2012

First Posted

February 24, 2012

Study Start

December 1, 2003

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

March 7, 2016

Record last verified: 2016-03

Locations

JP(1)