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

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
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.

Overall Status Completed
Start Date November 2011
Completion Date October 2012
Primary Completion Date October 2012
Study Type Observational
Primary Outcome
Measure Time Frame
Number of adverse events and technical complaints Week 0-24
Secondary Outcome
Measure Time Frame
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
Enrollment 1031
Condition
Intervention

Intervention Type: Device

Intervention Name: FlexPen®

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

Arm Group Label: Total study population

Intervention Type: Device

Intervention Name: NovoPen® 3

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

Arm Group Label: Total study population

Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
Facility:
Location Countries

Pakistan

Verification Date

June 2015

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Total study population

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov