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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014