Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-02-01 @ 7:58 PM
Study NCT ID:
NCT02690467
Status:
UNKNOWN
Last Update Posted:
2017-07-25
First Post:
2016-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-24', 'studyFirstSubmitDate': '2016-02-02', 'studyFirstSubmitQcDate': '2016-02-19', 'lastUpdatePostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fructosamine levels', 'timeFrame': '3 weeks', 'description': 'Change from baseline in fructosamine levels after 3 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Glycemic variability expressed as the standard deviation of fasting blood and postprandial glucose levels', 'timeFrame': '3 weeks', 'description': 'Change from baseline in glycemic variability after 3 weeks of treatment'}, {'measure': 'Daily insulin dose', 'timeFrame': '3 weeks', 'description': 'Change from baseline in daily insulin dose after 3 weeks of treatment'}, {'measure': 'Body weight', 'timeFrame': '3 weeks', 'description': 'Change from baseline in body weight after 3 weeks of treatment'}, {'measure': 'Pain', 'timeFrame': '3 weeks', 'description': 'Pain measured by visual analogue scale after 3 weeks of treatment'}, {'measure': 'Patient satisfaction measured by a questionnaire', 'timeFrame': '3 weeks', 'description': 'Patient satisfaction measured by a questionnaire after 3 weeks of treatment'}, {'measure': 'Number of patients with hypoglycaemia', 'timeFrame': '3 weeks', 'description': 'Number of patients with hypoglycaemia during 3 weeks'}, {'measure': 'Number of hypoglycaemia episodes', 'timeFrame': '3 weeks', 'description': 'Total number of phypoglycaemia episodes during 3 weeks'}, {'measure': 'Number of episodes of insulin leakage at injection site', 'timeFrame': '3 weeks', 'description': 'Number of episodes of insulin leakage at injection site during 3 weeks of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Insulin therapy', 'Needle'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '29924641', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with type 1 or type 2 diabetes\n* Age \\>= 18 years\n* Multiple daily injections of insulin for at least 6 months\n* Signed informed consent\n\nExclusion Criteria:\n\n* Pregnancy or or breast feeding\n* Inability to fill in the questionnaire\n* Combined therapy for diabetes (oral drugs associated with insulin injections)\n* Any medical condition that could interfere with the study according to the investigator's opinion"}, 'identificationModule': {'nctId': 'NCT02690467', 'acronym': 'AGO 02', 'briefTitle': 'Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.', 'organization': {'class': 'OTHER', 'fullName': 'Center for Outcomes Research and Clinical Epidemiology, Italy'}, 'officialTitle': 'Efficacy, Safety and Acceptability of the New Pen Needle 33G x 4 mm: a Cross-over Randomised Non Inferiority Trial', 'orgStudyIdInfo': {'id': 'AGO 02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insupen G34x3,5mm', 'description': 'Needle for insulin pen 3,5 mm long and with a diameter of 34 gauge', 'interventionNames': ['Device: Insupen G34x3,5mm']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insupen G32x4mm', 'description': 'Needle for insulin pen 4 mm long and with a diameter of 32 gauge', 'interventionNames': ['Device: Insupen G32x4mm']}], 'interventions': [{'name': 'Insupen G34x3,5mm', 'type': 'DEVICE', 'armGroupLabels': ['Insupen G34x3,5mm']}, {'name': 'Insupen G32x4mm', 'type': 'DEVICE', 'armGroupLabels': ['Insupen G32x4mm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24047', 'city': 'Treviglio', 'state': 'BG', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Bossi, MD', 'role': 'CONTACT', 'email': 'antonio_bossi@ospedale.treviglio.bg.it', 'phone': '+39 0363 424261'}], 'facility': 'U.O. Malattie Metaboliche e Diabetologia - Ospedale Treviglio', 'geoPoint': {'lat': 45.52081, 'lon': 9.59102}}, {'city': 'Mariano Comense', 'state': 'CO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luigi Sciangula, MD', 'role': 'CONTACT', 'email': 'luigi.sciangula@hsacomo.org', 'phone': '+39 031 755355'}], 'facility': 'Struttura Semplice Dipartimentale di Diabetologia e Malattie Metaboliche - Az. Osp. S. Anna - PO Cantù', 'geoPoint': {'lat': 45.69651, 'lon': 9.1818}}, {'city': 'Desio', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Marelli, MD', 'role': 'CONTACT', 'email': 'giuseppe.marelli@aovimercate.org', 'phone': '+39 0362383013'}], 'facility': 'Struttura Semplice Dipartimentale Diabetologia, Endocrinologia e Nutrizione Clinica - Az. Osp. Desio e Vimercate', 'geoPoint': {'lat': 45.61831, 'lon': 9.20249}}, {'zip': '00157', 'city': 'Roma', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sergio Leotta, MD', 'role': 'CONTACT', 'email': 's.leotta@tiscali.it', 'phone': '+39 06 41433402'}], 'facility': 'Struttura Complessa Dietologia - Diabetologia Malattie Metaboliche - Ospedale Pertini', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Antonio Nicolucci, MD', 'role': 'CONTACT', 'email': 'nicolucci@coresearch.it', 'phone': '+39 085 9047114'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Outcomes Research and Clinical Epidemiology, Italy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Artsana S.p.a.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}