Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.

Efficacy, Safety and Acceptability of the New Pen Needle 33G x 4 mm: a Cross-over Randomised Non Inferiority Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02690467

Acronym

AGO 02

Enrollment

Registered

2016-02-24

Start date

2016-09-06

Completion date

2017-07-31

Last updated

2017-07-25

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

Conditions

Diabetes Mellitus

Keywords

Insulin therapy, Needle

Brief summary

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.

Interventions

DEVICEInsupen G34x3,5mm

DEVICEInsupen G32x4mm

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 * 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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Daily insulin dose	3 weeks	Change from baseline in daily insulin dose after 3 weeks of treatment
Body weight	3 weeks	Change from baseline in body weight after 3 weeks of treatment
Pain	3 weeks	Pain measured by visual analogue scale after 3 weeks of treatment
Glycemic variability expressed as the standard deviation of fasting blood and postprandial glucose levels	3 weeks	Change from baseline in glycemic variability after 3 weeks of treatment
Number of patients with hypoglycaemia	3 weeks	Number of patients with hypoglycaemia during 3 weeks
Number of hypoglycaemia episodes	3 weeks	Total number of phypoglycaemia episodes during 3 weeks
Number of episodes of insulin leakage at injection site	3 weeks	Number of episodes of insulin leakage at injection site during 3 weeks of treatment
Patient satisfaction measured by a questionnaire	3 weeks	Patient satisfaction measured by a questionnaire after 3 weeks of treatment

Countries

Italy

Contacts

Primary ContactAntonio Nicolucci, MD

nicolucci@coresearch.it+39 085 9047114

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026