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

Diabetes Mellitus Clinical Trial

— AGO 02  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02690467
• Other study ID #: AGO 02
• Status: Recruiting
• Phase: N/A
• First received: February 2, 2016
• Last updated: July 24, 2017
• Start date: September 6, 2016
• Est. completion date: July 31, 2017

Study information

• Verified date: January 2017
• Source: Center for Outcomes Research and Clinical Epidemiology, Italy
• Contact: Antonio Nicolucci, MD
• Phone: +39 085 9047114
• Email: nicolucci[@]coresearch.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2017
• Est. primary completion date: March 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Insupen G34x3,5mm

• Insupen G32x4mm

Locations

Country	Name	City	State
Italy	Struttura Semplice Dipartimentale Diabetologia, Endocrinologia e Nutrizione Clinica - Az. Osp. Desio e Vimercate	Desio	MI
Italy	Struttura Semplice Dipartimentale di Diabetologia e Malattie Metaboliche - Az. Osp. S. Anna - PO Cantù	Mariano Comense	CO
Italy	Struttura Complessa Dietologia - Diabetologia Malattie Metaboliche - Ospedale Pertini	Roma	RM
Italy	U.O. Malattie Metaboliche e Diabetologia - Ospedale Treviglio	Treviglio	BG

Sponsors (2)

Lead Sponsor	Collaborator
Center for Outcomes Research and Clinical Epidemiology, Italy	Artsana S.p.a.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fructosamine levels	Change from baseline in fructosamine levels after 3 weeks of treatment	3 weeks
Secondary	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
Secondary	Daily insulin dose	Change from baseline in daily insulin dose after 3 weeks of treatment	3 weeks
Secondary	Body weight	Change from baseline in body weight after 3 weeks of treatment	3 weeks
Secondary	Pain	Pain measured by visual analogue scale after 3 weeks of treatment	3 weeks
Secondary	Patient satisfaction measured by a questionnaire	Patient satisfaction measured by a questionnaire after 3 weeks of treatment	3 weeks
Secondary	Number of patients with hypoglycaemia	Number of patients with hypoglycaemia during 3 weeks	3 weeks
Secondary	Number of hypoglycaemia episodes	Total number of phypoglycaemia episodes during 3 weeks	3 weeks
Secondary	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