Paediatric Subjects - Special Survey

March 3, 2016 updated by: Novo Nordisk A/S

Special Survey for Paediatric Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 1000005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Subjects with diabetes requiring insulin therapy

Exclusion Criteria:

  • Subjects who had treatment history of insulin aspart

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Insulin aspart users
Drug: insulin aspart
Prescribed by the physicians as a result of normal clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control
Time Frame: Year 1
Year 1
HbA1c (glycosylated haemoglobin)
Time Frame: Year 1
Year 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Hypoglycaemic events
Time Frame: Year 1
Year 1
Adverse Events
Time Frame: Year 1
Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

February 15, 2012

First Submitted That Met QC Criteria

February 20, 2012

First Posted (ESTIMATE)

February 24, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 7, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1942

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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