Skip to main content
OpenTrials
Completed

NCT Number: NCT01454024

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Autoimmune Diseases Delivery Systems Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Karachi, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FlexPen®

Device

Prescribed insulin treatment delivered by FlexPen® as part of routine clinical practice

NovoPen® 3

Device

Prescribed insulin treatment delivered by NovoPen® 3 as part of routine clinical practice

Primary outcomes

  1. Number of adverse events and technical complaints

    Time frame: Week 0-24

Secondary outcomes

  1. Number of adverse drug reactions (ADR) including hypoglycaemic events

    Time frame: Week 0-12, week 24

  2. Number of serious adverse drug reactions including major hypoglycaemic events

    Time frame: Week 0-12, week 24

  3. HbA1c (haemoglobin A1c)

    Time frame: Week 0, week 12 and week 24

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 18, 2011
Registry last updated
Jun 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.