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

C

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)

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

Trial contacts and locations

4

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Central trial contact

Antonio Nicolucci, MD

Data sourced from clinicaltrials.gov

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