Special Survey of Production of Insulin Aspart Specific Antibody

Completed

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

• Registration Number: NCT01487369
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Japan. The aim of this study is to collect data of production of insulin aspart specific antibody under normal clinical practice conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

• Patients with diabetes requiring insulin therapy

Exclusion Criteria

• Patients who had a treatment history of NovoRapid® (insulin aspart)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Insulin Aspart	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Antibody titre findings

Secondary Outcome Measures

Name	Time	Method
Hypoglycemic events
HbA1c (glycosylated haemoglobin)
Adverse events