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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
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	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	87 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (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
Study Start Date :	December 2012
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	November 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. hematic fructosamine levels [ Time Frame: Change from baseline in fructosamine levels after 3 weeks of treatment ]

Secondary Outcome Measures :

1. mean amplitude of glucose excursions (MAGE) [ Time Frame: Change from baseline in MAGE after 3 weeks of treatment ]
2. pain [ Time Frame: questionnaire at the end of the treatments (at 6 weeks) ]
   visual analogic scale (VAS) 1-10
3. leakage at the site injection [ Time Frame: number of episodes of leakage during the treatment (3 weeks) ]
   visual scale
4. hypoglycemia [ Time Frame: number of episodes of hypoglycemia during the treatment (3 weeks) ]
5. insulin dosage [ Time Frame: Change from baseline in insulin dosage after 3 weeks of treatment ]
6. patient's weight [ Time Frame: Change from baseline in weight after 3 weeks of treatment ]
7. patient's satisfaction [ Time Frame: questionnaire at the end of the treatments (at 6 weeks) ]
   VAS scale

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	December 10, 2012
Last Update Posted:	March 18, 2014
Last Verified:	March 2014

Keywords provided by Antonio Nicolucci, 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