Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
AGO 02
1 other identifier
interventional
80
1 country
4
Brief Summary
The purpose of this study is to determine the non-inferiority of a new Pic Insupen 34Gx3,5mm needle vs. a 32Gx4mm needle in terms of metabolic control, safety and acceptability in patients with diabetes treated with insulin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Sep 2016
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2016
CompletedFirst Posted
Study publicly available on registry
February 24, 2016
CompletedStudy Start
First participant enrolled
September 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2017
CompletedJuly 25, 2017
January 1, 2017
7 months
February 2, 2016
July 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fructosamine levels
Change from baseline in fructosamine levels after 3 weeks of treatment
3 weeks
Secondary Outcomes (8)
Glycemic variability expressed as the standard deviation of fasting blood and postprandial glucose levels
3 weeks
Daily insulin dose
3 weeks
Body weight
3 weeks
Pain
3 weeks
Patient satisfaction measured by a questionnaire
3 weeks
- +3 more secondary outcomes
Study Arms (2)
Insupen G34x3,5mm
EXPERIMENTALNeedle for insulin pen 3,5 mm long and with a diameter of 34 gauge
Insupen G32x4mm
ACTIVE COMPARATORNeedle for insulin pen 4 mm long and with a diameter of 32 gauge
Interventions
Eligibility Criteria
You may qualify if:
- Patients with type 1 or type 2 diabetes
- Age \>= 18 years
- Multiple daily injections of insulin for at least 6 months
- Signed informed consent
You may not qualify if:
- Pregnancy or or breast feeding
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
U.O. Malattie Metaboliche e Diabetologia - Ospedale Treviglio
Treviglio, BG, 24047, 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, 00157, Italy
Related Publications (1)
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.
PMID: 29924641DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2016
First Posted
February 24, 2016
Study Start
September 6, 2016
Primary Completion
March 23, 2017
Study Completion
July 31, 2017
Last Updated
July 25, 2017
Record last verified: 2017-01