Evaluating Safety of NovoPen® 3 and/or FlexPen® Devices in Routine Clinical Practice
A Study Evaluating the Safety of NovoPen®3 and FlexPen® in Subjects With Type 1 and Type 2 Diabetes. A 24-week, Prospective, Multi-centre, Open-labelled, Non-interventional Study
2 other identifiers
observational
1,031
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2011
CompletedFirst Posted
Study publicly available on registry
October 18, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJune 12, 2015
June 1, 2015
11 months
October 13, 2011
June 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of adverse events and technical complaints
Week 0-24
Secondary Outcomes (3)
Number of adverse drug reactions (ADR) including hypoglycaemic events
Week 0-12, week 24
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
Study Arms (1)
Total study population
Interventions
Prescribed insulin treatment delivered by FlexPen® as part of routine clinical practice
Prescribed insulin treatment delivered by NovoPen® 3 as part of routine clinical practice
Eligibility Criteria
The selection of the subjects will be at the discretion of the individual physician based on clinical judgement.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Karachi, Pakistan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2011
First Posted
October 18, 2011
Study Start
November 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
June 12, 2015
Record last verified: 2015-06