Comparison of Two Pen Systems in Patients With Diabetes Treated With Insulin

An Open-label, Multi-centre, Multi-national, Comparative, Randomised, Cross-over Trial Evaluating Preference as Well as Performance, Acceptance, Handling and Safety of NovoPen™ 4 (MS236) Versus NovoPen 3® in Insulin Treated Diabetic Patients

This trial is conducted in Europe. The aim of this trial is to compare two insulin delivery pens in the everyday life setting of patients with diabetes treated with insulin.

Inclusion Criteria:

• Type 1 or type 2 diabetes mellitus for at least 12 months
• Adults at least 18 years
• Children/adolescents between 9-18 years
• HbA1c lesser than or equal to 11.0%

Exclusion Criteria:

• Known or suspected alcohol or drug abuse
• Patients who are not able to read the user manual (may wear glasses if needed)
• Hypoglycaemic unawareness as judged by the investigator
• Visual and/or dexterity impairments as judged by the investigator