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

Efficacy, Safety and Satisfaction of the New Pen Needle 33G x 4 mm 33G x 4 mm: Cross-over Randomized Controlled Clinical Trial. Studio AGO 01

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01745549

Acronym

AGO01

Enrollment

Registered

2012-12-10

Start date

2012-12-31

Completion date

2013-11-30

Last updated

2014-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes, Type 2 Diabetes

Keywords

diabetes, insulin therapy, needle

Brief 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.

Interventions

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

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients with type 1 or type 2 diabetes * both males and females * age \>=18 anni * insulin treatment from at least 6 months * signed informed consent

Exclusion criteria

* pregnancy * incapacity for filling in the questionnaires * every illness or condition that, according to the investigator, could interfere with the study

Design outcomes

Primary

Measure	Time frame
hematic fructosamine levels	Change from baseline in fructosamine levels after 3 weeks of treatment

Secondary

Measure	Time frame	Description
pain	questionnaire at the end of the treatments (at 6 weeks)	visual analogic scale (VAS) 1-10
leakage at the site injection	number of episodes of leakage during the treatment (3 weeks)	visual scale
hypoglycemia	number of episodes of hypoglycemia during the treatment (3 weeks)	—
mean amplitude of glucose excursions (MAGE)	Change from baseline in MAGE after 3 weeks of treatment	—
patient's weight	Change from baseline in weight after 3 weeks of treatment	—
patient's satisfaction	questionnaire at the end of the treatments (at 6 weeks)	VAS scale
insulin dosage	Change from baseline in insulin dosage after 3 weeks of treatment	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026