Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Delivery Systems
Conditions
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.
Interventions
DEVICEFlexPen®
Prescribed insulin treatment delivered by FlexPen® as part of routine clinical practice
DEVICENovoPen® 3
Prescribed insulin treatment delivered by NovoPen® 3 as part of routine clinical practice
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events and technical complaints | Week 0-24 |
Secondary
| 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 |
Countries
Pakistan
Outcome results
None listed