Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
NCT ID: NCT02690467
Last Updated: 2017-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2016-09-06
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Insupen G34x3,5mm
Needle for insulin pen 3,5 mm long and with a diameter of 34 gauge
Insupen G34x3,5mm
Insupen G32x4mm
Needle for insulin pen 4 mm long and with a diameter of 32 gauge
Insupen G32x4mm
Interventions
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Insupen G34x3,5mm
Insupen G32x4mm
Eligibility Criteria
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Inclusion Criteria
* Age \>= 18 years
* Multiple daily injections of insulin for at least 6 months
* Signed informed consent
Exclusion Criteria
* Inability to fill in the questionnaire
* Combined therapy for diabetes (oral drugs associated with insulin injections)
* Any medical condition that could interfere with the study according to the investigator's opinion
18 Years
ALL
No
Sponsors
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Artsana S.p.a.
INDUSTRY
Center for Outcomes Research and Clinical Epidemiology, Italy
OTHER
Responsible Party
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Locations
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U.O. Malattie Metaboliche e Diabetologia - Ospedale Treviglio
Treviglio, BG, Italy
Struttura Semplice Dipartimentale di Diabetologia e Malattie Metaboliche - Az. Osp. S. Anna - PO Cantù
Mariano Comense, CO, Italy
Struttura Semplice Dipartimentale Diabetologia, Endocrinologia e Nutrizione Clinica - Az. Osp. Desio e Vimercate
Desio, MI, Italy
Struttura Complessa Dietologia - Diabetologia Malattie Metaboliche - Ospedale Pertini
Roma, RM, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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De Berardis G, Scardapane M, Lucisano G, Abbruzzese S, Bossi AC, Cipponeri E, D'Angelo P, Fontana L, Lancione R, Marelli G, Sciangula L, Nicolucci A. Efficacy, safety and acceptability of the new pen needle 34G x 3.5 mm: a crossover randomized non-inferiority trial; AGO 02 study. Curr Med Res Opin. 2018 Sep;34(9):1699-1704. doi: 10.1080/03007995.2018.1491396. Epub 2018 Jul 5.
Other Identifiers
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AGO 02
Identifier Type: -
Identifier Source: org_study_id
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