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

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2; Delivery Systems

Treatments: Device: FlexPen®; Device: NovoPen® 3

Study type: Observational

Funder types: Industry

Identifiers

NCT01454024

U1111-1116-2517 (Other Identifier)

NOPEN3-3882

Details and patient eligibility

About

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.

Enrollment: 1,031 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,031 participants in 1 patient group

Total study population

Treatment:

Device: FlexPen®

Device: NovoPen® 3