Clinical trial NCT01745549: Efficacy, Safety and Satisfaction of the New Pen Needle 33 Gauge x 4 mm.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: diabetes
insulin therapy
needle
Lead sponsor: Consorzio Mario Negri Sud
Sponsor class: OTHER
Collaborators: name: Artsana SpA
First posted: 2012-12-10
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: hematic fructosamine levels
timeFrame: Change from baseline in fructosamine levels after 3 weeks of treatment
Secondary outcomes:
measure: mean amplitude of glucose excursions (MAGE)
timeFrame: Change from baseline in MAGE after 3 weeks of treatment
measure: pain
timeFrame: questionnaire at the end of the treatments (at 6 weeks)
measure: leakage at the site injection
timeFrame: number of episodes of leakage during the treatment (3 weeks)
measure: hypoglycemia
timeFrame: number of episodes of hypoglycemia during the treatment (3 weeks)
measure: insulin dosage
timeFrame: Change from baseline in insulin dosage after 3 weeks of treatment
measure: patient's weight
timeFrame: Change from baseline in weight after 3 weeks of treatment
measure: patient's satisfaction
timeFrame: questionnaire at the end of the treatments (at 6 weeks)
Other outcomes:
Locations:
city: Treviglio
country: Italy
facility: UO Malattie Metaboliche e Diabetologia - Ospedale di Treviglio-Caravaggio
state: BG
city: Brescia
country: Italy
facility: UO Diabetologia per Trattamento e Educazione dei Diabetici - Spedali Civili di Brescia
state: BS
city: Mariano Comense
country: Italy
facility: U.O.S. Diabetologia e Malattie Metaboliche - PO Cantù - Mariano Comense
state: CO
city: Roma
country: Italy
facility: Struttura Complessa Dietologia-Diabetologia Malattie Metaboliche - Ospedale Pertini
state: RM
Study officials:
affiliation: Consorzio Mario Negri Sud
name: Antonio Nicolucci, MD
role: STUDY_CHAIR
References:
citation: 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.