Efficacy, Safety and Satisfaction of the New Pen Needle 33 Gauge x 4 mm. (AGO01)

This study has been completed.

Sponsor:

Collaborator:

Artsana SpA

Information provided by (Responsible Party):

Antonio Nicolucci, Consorzio Mario Negri Sud

ClinicalTrials.gov Identifier:

NCT01745549

First received: December 5, 2012

Last updated: March 17, 2014

Last verified: March 2014

History of Changes

Purpose

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.

Condition	Intervention
Type 1 Diabetes Type 2 Diabetes	Device: Needle for insulin pen, 4 mm long and with a diameter of 33 gauge Device: Needle for insulin pen, 4 mm long and with a diameter of 32 gauge


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

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

Drug Information available for: Insulin Insulin human

U.S. FDA Resources

Further study details as provided by Consorzio Mario Negri Sud:

Primary Outcome Measures:

hematic fructosamine levels [ Time Frame: Change from baseline in fructosamine levels after 3 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

mean amplitude of glucose excursions (MAGE) [ Time Frame: Change from baseline in MAGE after 3 weeks of treatment ] [ Designated as safety issue: No ]
pain [ Time Frame: questionnaire at the end of the treatments (at 6 weeks) ] [ Designated as safety issue: No ]
visual analogic scale (VAS) 1-10
leakage at the site injection [ Time Frame: number of episodes of leakage during the treatment (3 weeks) ] [ Designated as safety issue: No ]
visual scale
hypoglycemia [ Time Frame: number of episodes of hypoglycemia during the treatment (3 weeks) ] [ Designated as safety issue: Yes ]
insulin dosage [ Time Frame: Change from baseline in insulin dosage after 3 weeks of treatment ] [ Designated as safety issue: No ]
patient's weight [ Time Frame: Change from baseline in weight after 3 weeks of treatment ] [ Designated as safety issue: No ]
patient's satisfaction [ Time Frame: questionnaire at the end of the treatments (at 6 weeks) ] [ Designated as safety issue: No ]
VAS scale


Enrollment:	87
Study Start Date:	December 2012
Study Completion Date:	November 2013
Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: needle 4 mm gauge 33 Needle for insulin pen, 4 mm long and with a diameter of 33 gauge (the smaller needle)	Device: Needle for insulin pen, 4 mm long and with a diameter of 33 gauge
Active Comparator: needle 4 mm gauge 32 Needle for insulin pen, 4 mm long and with a diameter of 32 gauge	Device: Needle for insulin pen, 4 mm long and with a diameter of 32 gauge

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745549

Locations


Italy
UO Malattie Metaboliche e Diabetologia - Ospedale di Treviglio-Caravaggio
Treviglio, BG, Italy, 24047
UO Diabetologia per Trattamento e Educazione dei Diabetici - Spedali Civili di Brescia
Brescia, BS, Italy, 25123
U.O.S. Diabetologia e Malattie Metaboliche - PO Cantù - Mariano Comense
Mariano Comense, CO, Italy, 22066
Struttura Complessa Dietologia-Diabetologia Malattie Metaboliche - Ospedale Pertini
Roma, RM, Italy, 00157

Sponsors and Collaborators

Consorzio Mario Negri Sud

Artsana SpA

Investigators


Study Chair:	Antonio Nicolucci, MD	Consorzio Mario Negri Sud

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Valentini M, Scardapane M, Bondanini F, Bossi A, Colatrella A, Girelli A, Ciucci A, Leotta S, Minotti E, Pasotti F, Pesenti A, Rocca L, Sciangula L, Vavassori E, Nicolucci A. Efficacy, safety and acceptability of the new pen needle 33G × 4 mm. AGO 01 study. Curr Med Res Opin. 2015 Mar;31(3):487-92. doi: 10.1185/03007995.2014.993025. Epub 2014 Dec 10.


Responsible Party:	Antonio Nicolucci, Dr Antonio Nicolucci, MD, Consorzio Mario Negri Sud
ClinicalTrials.gov Identifier:	NCT01745549 History of Changes
Other Study ID Numbers:	AGO01
Study First Received:	December 5, 2012
Last Updated:	March 17, 2014
Health Authority:	Italy: Ministry of Health

Keywords provided by Consorzio Mario Negri Sud:


diabetes insulin therapy needle

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases	Immune System Diseases Insulin, Globin Zinc Insulin Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016

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