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NCT01454024 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01454024
Other study ID # NOPEN3-3882
Secondary ID U1111-1116-2517
Status Completed
Phase N/A
First received October 13, 2011
Last updated June 11, 2015
Start date November 2011
Est. completion date October 2012

Study information
Verified date June 2015
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Pakistan: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1031
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• FlexPen®
Prescribed insulin treatment delivered by FlexPen® as part of routine clinical practice
• NovoPen® 3
Prescribed insulin treatment delivered by NovoPen® 3 as part of routine clinical practice

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of adverse events and technical complaints Week 0-24 No
Secondary Number of adverse drug reactions (ADR) including hypoglycaemic events Week 0-12, week 24 No
Secondary Number of serious adverse drug reactions including major hypoglycaemic events Week 0-12, week 24 No
Secondary HbA1c (haemoglobin A1c) Week 0, week 12 and week 24 No
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