Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm. (AGO 02)

Center for Outcomes Research and Clinical Epidemiology, Italy

Status: Unknown

Conditions: Diabetes Mellitus

Treatments: Device: Insupen G32x4mm; Device: Insupen G34x3,5mm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02690467

AGO 02

Details and patient eligibility

About

The purpose of this study is to determine the non-inferiority of a new Pic Insupen 34Gx3,5mm needle vs. a 32Gx4mm needle in terms of metabolic control, safety and acceptability in patients with diabetes treated with insulin.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 1 or type 2 diabetes
• Age >= 18 years
• Multiple daily injections of insulin for at least 6 months
• Signed informed consent

Exclusion criteria

• Pregnancy or or breast feeding
• Inability to fill in the questionnaire
• Combined therapy for diabetes (oral drugs associated with insulin injections)
• Any medical condition that could interfere with the study according to the investigator's opinion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Insupen G34x3,5mm

Experimental group

Description:

Needle for insulin pen 3,5 mm long and with a diameter of 34 gauge

Treatment:

Device: Insupen G34x3,5mm

Insupen G32x4mm

Active Comparator group

Description:

Needle for insulin pen 4 mm long and with a diameter of 32 gauge

Treatment:

Device: Insupen G32x4mm