Evaluating the Use of Two Different Needles in Subjects With Diabetes

Novo Nordisk

Status and phase: Completed; Phase 4

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

Treatments: Device: NovoFine® needle 8 mm; Device: NovoFine® needle 6 mm

Study type: Interventional

Funder types: Industry

Identifiers

NCT00569426

NEEDLEN-1637

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to compare two needle types when used with a disposable insulin injection pen in the everyday life setting of an insulin treated patient with diabetes.

Enrollment: 119 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed and dated informed consent obtained before any trial-related activities
• Diagnosed type 1 or type 2 diabetes
• Treated with insulin

Exclusion criteria

• Previous participation in this trial
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
• Any disease or condition which the investigator feels would interfere with the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)