Evaluating Safety of NovoPen® 3 and/or FlexPen® Devices in Routine Clinical Practice

Completed

• Conditions: Delivery Systems; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Diabetes
• Interventions: Device: FlexPen®; Device: NovoPen® 3

• Registration Number: NCT01454024
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Asia. The aim of of this study is to evaluate the safety of NovoPen® 3 and/or FlexPen® devices (if available on the market) measured by the number of adverse events and technical complaints in patients with type 1 and type 2 diabetes in routine clinical practice.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-17
• Study First Posted: 2011-10-18
• Study Start: 2011-11
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-11
• Last Update Posted: 2015-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1031

Inclusion Criteria

• Any subjects who are previously using Actrapid®, Insulatard®, and Mixtard® 30 with vial / NovoLet® or insulin human with ErgoPen®2 for type 1 and type 2 diabetes treatment, will be eligible for the study after the physician has taken the decision to use study insulin products with the study devices

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Exclusion Criteria

• Subjects treated with Actrapid® Penfill®, Insulatard® Penfill®, or Mixtard® 30 Penfill® with NovoPen®3 or Actrapid® FlexPen®, Insulatard® FlexPen®, or Mixtard® 30 FlexPen® for more than 4 weeks before inclusion into this study
• Subjects who were previously enrolled in this study
• Subjects with a hypersensitivity to insulin human or to any of the excipients
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total study population	FlexPen®	-
Total study population	NovoPen® 3	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events and technical complaints	Week 0-24

Secondary Outcome Measures

Name	Time	Method
Number of serious adverse drug reactions including major hypoglycaemic events	Week 0-12, week 24
HbA1c (haemoglobin A1c)	Week 0, week 12 and week 24
Number of adverse drug reactions (ADR) including hypoglycaemic events	Week 0-12, week 24