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

NCT01745549 — Not applicable, Completed, 87 participants, Consorzio Mario Negri Sud

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT01745549, acronym AGO01
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	87 (Actual)
Sponsor	Consorzio Mario Negri Sud (Other); collaborators: Artsana S.p.a.
Conditions	Type 1 Diabetes, Type 2 Diabetes
Interventions	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 (Device)
Dates	start 2012-12-01, primary completion 2013-09-01, completion 2013-11-01, first posted 2012-12-10, last updated 2014-03-18
Locations	4 sites in Italy

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
needle 4 mm gauge 33	Experimental	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 33 gauge (the smaller needle)
needle 4 mm gauge 32	Active comparator	Device: Needle for insulin pen, 4 mm long and with a diameter of 32 gauge	Needle for insulin pen, 4 mm long and with a diameter of 32 gauge

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 (Device)

+Outcome measures

Primary outcomes

hematic fructosamine levels [Change from baseline in fructosamine levels after 3 weeks of treatment]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (4)

Facility	City	Country
UO Malattie Metaboliche e Diabetologia - Ospedale di Treviglio-Caravaggio	Treviglio, BG	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

+Publications

Results publication: 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 x 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. PMID 25469829

+Investigators

Antonio Nicolucci, MD, Study chair, Consorzio Mario Negri Sud

My Notes

Public

To Read Reading Read