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OpenTrials
Completed

NCT Number: NCT01538576

Paediatric Subjects - Special Survey

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with diabetes requiring insulin therapy

Exclusion criteria

  • Subjects who had treatment history of insulin aspart

Treatment and study plan

insulin aspart

Drug

Prescribed by the physicians as a result of normal clinical practice

Primary outcomes

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

    Time frame: Year 1

  2. HbA1c (glycosylated haemoglobin)

    Time frame: Year 1

Secondary outcomes

  1. Hypoglycaemic events

    Time frame: Year 1

  2. Adverse Events

    Time frame: Year 1

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Special Survey for Paediatric Subjects

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Feb 24, 2012
Registry last updated
Mar 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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