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

Novo Nordisk

Status and phase: Completed; Phase 3

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

Treatments: Device: NovoPen™ 4; Device: NovoPen® 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT00569998

MS236-1544

Details and patient eligibility

About

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.

Enrollment: 208 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)