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Efficacy, Safety and Satisfaction of the New Pen Needle 33 Gauge x 4 mm.

NCT01745549 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2014-03-18

No results posted yet for this study

Summary

During the last years, even more little needles are used for the injection of sub cutaneous insulin, for the diabetes therapy.

The aim of this study is to evaluate the non inferiority of a new needle, smaller than another needle, in terms of hematic levels od fructosamine, an indicator of glycemic control.

Conditions

Interventions

DEVICE

Needle for insulin pen, 4 mm long and with a diameter of 33 gauge

DEVICE

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

Sponsors & Collaborators

  • Artsana SpA

    collaborator UNKNOWN

  • Consorzio Mario Negri Sud

    lead OTHER

Principal Investigators

  • Antonio Nicolucci, MD · Consorzio Mario Negri Sud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-09-30
Completion
2013-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01745549 on ClinicalTrials.gov