Special Survey for Patients With Type 1 or Type 2 Diabetes

Completed

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

• Registration Number: NCT01538589
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia under normal clinical practice.

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: 1582

Inclusion Criteria

• Patients with no treatment history of insulin aspart (NovoRapid®)

Exclusion Criteria

Not provided

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
Occurrence of severe hypoglycaemic symptoms	Year 2 for patients who had an antibody titre test performed
Antibody titre findings	Year 2 for patients who had an antibody titre test performed
Adverse events	Year 2 for patients who had an antibody titre test performed

Secondary Outcome Measures

Name	Time	Method
Total dose of insulin infused subcutaneously	Year 2 for patients who had an antibody titre test performed
Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control	Year 2 for patients who had an antibody titre test performed
HbA1c (glycosylated haemoglobin)	Year 2 for patients who had an antibody titre test performed