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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Insupen G34x3,5mm; Device: Insupen G32x4mm

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio Nicolucci, MD; Phone Number: +39 085 9047114; Email: nicolucci@coresearch.it

Study Locations

• Italy
  • BG
    • Treviglio, BG, Italy, 24047
      • Recruiting
      • U.O. Malattie Metaboliche e Diabetologia - Ospedale Treviglio
      • Contact: Antonio Bossi, MD; Phone Number: +39 0363 424261; Email: antonio_bossi@ospedale.treviglio.bg.it
  • CO
    • Mariano Comense, CO, Italy
      • Recruiting
      • Struttura Semplice Dipartimentale di Diabetologia e Malattie Metaboliche - Az. Osp. S. Anna - PO Cantù
      • Contact: Luigi Sciangula, MD; Phone Number: +39 031 755355; Email: luigi.sciangula@hsacomo.org
  • MI
    • Desio, MI, Italy
      • Recruiting
      • Struttura Semplice Dipartimentale Diabetologia, Endocrinologia e Nutrizione Clinica - Az. Osp. Desio e Vimercate
      • Contact: Giuseppe Marelli, MD; Phone Number: +39 0362383013; Email: giuseppe.marelli@aovimercate.org
  • RM
    • Roma, RM, Italy, 00157
      • Recruiting
      • Struttura Complessa Dietologia - Diabetologia Malattie Metaboliche - Ospedale Pertini
      • Contact: Sergio Leotta, MD; Phone Number: +39 06 41433402; Email: s.leotta@tiscali.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Insupen G34x3,5mm; Needle for insulin pen 3,5 mm long and with a diameter of 34 gauge	Device: Insupen G34x3,5mm
ACTIVE_COMPARATOR: Insupen G32x4mm; Needle for insulin pen 4 mm long and with a diameter of 32 gauge	Device: Insupen G32x4mm

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Center for Outcomes Research and Clinical Epidemiology, Italy
• Collaborators: Artsana S.p.a.

Publications and helpful links

General Publications

• De Berardis G, Scardapane M, Lucisano G, Abbruzzese S, Bossi AC, Cipponeri E, D'Angelo P, Fontana L, Lancione R, Marelli G, Sciangula L, Nicolucci A. Efficacy, safety and acceptability of the new pen needle 34G x 3.5 mm: a crossover randomized non-inferiority trial; AGO 02 study. Curr Med Res Opin. 2018 Sep;34(9):1699-1704. doi: 10.1080/03007995.2018.1491396. Epub 2018 Jul 5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 6, 2016
• Primary Completion (ACTUAL): March 23, 2017
• Study Completion (ANTICIPATED): July 31, 2017

Study Registration Dates

• First Submitted: February 2, 2016
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (ESTIMATE): February 24, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Needle; Insulin therapy
• Other Study ID Numbers: AGO 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED