Paediatric Subjects - Special Survey

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin aspart

• Registration Number: NCT01538576
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-02-20
• Study First Posted: 2012-02-24
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Subjects with diabetes requiring insulin therapy

Exclusion Criteria

• Subjects who had treatment history of insulin aspart

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Insulin aspart users	insulin aspart	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Hypoglycaemic events	Year 1
Adverse Events	Year 1