Switch From Premixed Human Insulin to Biphasic Insulin Aspart in the Netherlands

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic insulin aspart 30

• Registration Number: NCT01536626
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of this observational study is to observe and investigate the process of switching from premixed human insulin 30/70 (BHI 30) to biphasic insulin aspart 30/70 (BIAsp 30) in an outpatient setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-09
• Primary Completion: 2007-04-10
• Study Completion: 2007-04-10
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-22
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

• Type 2 diabetic subjects treated with BHI 30

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BIAsp 30 users	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
HbA1c (glycosylated haemoglobin)

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QoL) using the World Health Organization Wellbeing Index (WHO-5)
Number of hypoglycaemic events
Treatment satisfaction: ITSQ (Insulin Treatment Satisfaction Questionnaire)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇳🇱 Alphen a/d Rijn, Netherlands