Observational Study With Mixtard® 30 NovoLet® to Assess Patient Satisfaction

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic human insulin 30

• Registration Number: NCT01492218
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Asia. The aim of this study is to assess patient satisfaction after switching to biphasic human insulin 30 treatment using the NovoLet® insulin device as treatment for diabetes mellitus under normal clinical practice setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03-15
• Primary Completion: 2004-08-30
• Study Completion: 2004-08-30
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-14
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1330

Inclusion Criteria

• Diabetes mellitus (type 1 or type 2)
• Patient not presently using Mixtard® 30 NovoLet®

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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
NovoLet®	biphasic human insulin 30	-

Primary Outcome Measures

Name	Time	Method
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score

Secondary Outcome Measures

Name	Time	Method
Adverse events
Technical complaints of NovoLet® device

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇵🇭 Manilla, Philippines