Surveillance Study of NovoRapid® for New Drug Re-examination

Completed

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

• Registration Number: NCT01490112
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Asia. The aim of this study is to observe the safety and efficacy of insulin aspart (NovoRapid®) administered via vial and three different devices.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Study First Submitted: 2011-12-06
• Study First Submitted QC: 2011-12-08
• Study First Posted: 2011-12-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1239

Inclusion Criteria

• Subjects with diabetes mellitus (type 1, type 2, or gestational) prescribed with insulin aspart (NovoRapid®)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IAsp	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Change in weight

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose (FBG)
HbA1c (glycosylated haemoglobin)
Adverse events: Serious and non-serious

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇰🇷 Seoul, Korea, Republic of