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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01454024
First received: October 13, 2011
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Device: FlexPen®
Device: NovoPen® 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number of adverse events and technical complaints [ Time Frame: Week 0-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse drug reactions (ADR) including hypoglycaemic events [ Time Frame: Week 0-12, week 24 ] [ Designated as safety issue: No ]
  • Number of serious adverse drug reactions including major hypoglycaemic events [ Time Frame: Week 0-12, week 24 ] [ Designated as safety issue: No ]
  • HbA1c (haemoglobin A1c) [ Time Frame: Week 0, week 12 and week 24 ] [ Designated as safety issue: No ]

Enrollment: 1031
Study Start Date: November 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Total study population Device: FlexPen®
Prescribed insulin treatment delivered by FlexPen® as part of routine clinical practice
Device: NovoPen® 3
Prescribed insulin treatment delivered by NovoPen® 3 as part of routine clinical practice

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The selection of the subjects will be at the discretion of the individual physician based on clinical judgement.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454024

Locations
Pakistan
Karachi, Pakistan
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Volkan Manga Novo Nordisk Saglik Ürünleri Tic. Ltd. Sti.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01454024     History of Changes
Other Study ID Numbers: NOPEN3-3882, U1111-1116-2517
Study First Received: October 13, 2011
Last Updated: December 20, 2013
Health Authority: Pakistan: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014