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

Type 2 Diabetes Clinical Trial

— AGO01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745549
• Other study ID #: AGO01
• Status: Completed
• Phase: N/A
• First received: December 5, 2012
• Last updated: March 17, 2014
• Start date: December 2012
• Est. completion date: November 2013

Study information

• Verified date: March 2014
• Source: Consorzio Mario Negri Sud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

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

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

Locations

Country	Name	City	State
Italy	UO Diabetologia per Trattamento e Educazione dei Diabetici - Spedali Civili di Brescia	Brescia	BS
Italy	U.O.S. Diabetologia e Malattie Metaboliche - PO Cantù - Mariano Comense	Mariano Comense	CO
Italy	Struttura Complessa Dietologia-Diabetologia Malattie Metaboliche - Ospedale Pertini	Roma	RM
Italy	UO Malattie Metaboliche e Diabetologia - Ospedale di Treviglio-Caravaggio	Treviglio	BG

Sponsors (2)

Lead Sponsor	Collaborator
Consorzio Mario Negri Sud	Artsana SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hematic fructosamine levels		Change from baseline in fructosamine levels after 3 weeks of treatment	No
Secondary	mean amplitude of glucose excursions (MAGE)		Change from baseline in MAGE after 3 weeks of treatment	No
Secondary	pain	visual analogic scale (VAS) 1-10	questionnaire at the end of the treatments (at 6 weeks)	No
Secondary	leakage at the site injection	visual scale	number of episodes of leakage during the treatment (3 weeks)	No
Secondary	hypoglycemia		number of episodes of hypoglycemia during the treatment (3 weeks)	Yes
Secondary	insulin dosage		Change from baseline in insulin dosage after 3 weeks of treatment	No
Secondary	patient's weight		Change from baseline in weight after 3 weeks of treatment	No
Secondary	patient's satisfaction	VAS scale	questionnaire at the end of the treatments (at 6 weeks)	No