Status:
COMPLETED
Evaluating Safety of NovoPen® 3 and/or FlexPen® Devices in Routine Clinical Practice
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
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 tech...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
1031 Patients enrolled
Trial Details
Trial ID
NCT01454024
Start Date
November 1 2011
End Date
October 1 2012
Last Update
June 12 2015
Active Locations (1)
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1
Karachi, Pakistan