Delivery Systems, Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
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