{"protocolSection":{"identificationModule":{"nctId":"NCT03724981","orgStudyIdInfo":{"id":"17155"},"secondaryIdInfos":[{"id":"H9X-MC-B021","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study Comparing the Dulaglutide Pen and the Semaglutide Pen","officialTitle":"Crossover Study Comparing the Dulaglutide (Trulicity) Pen and the Semaglutide (Ozempic) Pen"},"statusModule":{"statusVerifiedDate":"2019-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-10-18","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2019-04-12","type":"ACTUAL"},"completionDateStruct":{"date":"2019-04-12","type":"ACTUAL"},"studyFirstSubmitDate":"2018-10-12","studyFirstSubmitQcDate":"2018-10-29","studyFirstPostDateStruct":{"date":"2018-10-30","type":"ACTUAL"},"resultsFirstSubmitDate":"2020-04-10","resultsFirstSubmitQcDate":"2020-04-10","resultsFirstPostDateStruct":{"date":"2020-04-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-04-10","lastUpdatePostDateStruct":{"date":"2020-04-24","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"In this study participants will try out two different types of drug injection pens (dulaglutide and semaglutide) on a practice pad and decide which device they prefer. No study drug will be administered."},"conditionsModule":{"conditions":["Diabetes Mellitus, Type 2"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"OTHER","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":312,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Dulaglutide Pen","type":"EXPERIMENTAL","description":"Injection of commercial dulaglutide pen on a practice pad.","interventionNames":["Drug: Dulaglutide Pen"]},{"label":"Semaglutide Pen","type":"EXPERIMENTAL","description":"Injection of commercial semaglutide pen on a practice pad.","interventionNames":["Drug: Semaglutide Pen"]}],"interventions":[{"type":"DRUG","name":"Dulaglutide Pen","description":"Injected on a practice pad.","armGroupLabels":["Dulaglutide Pen"]},{"type":"DRUG","name":"Semaglutide Pen","description":"Injected on a practice pad.","armGroupLabels":["Semaglutide Pen"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Participant Preference Between 2 Injection Devices Based on Global Preference Item","description":"Preference of injection device was assessed by questionnaire which asks, \"Overall, which device do you prefer?\" The Prescott test will be run to examine if a statistically significant difference in preference between the devices exits, while controlling for order effects and taking into account the neutral responses.","timeFrame":"Day 1"}],"secondaryOutcomes":[{"measure":"Participant Preference Between 2 Injection Devices Based on Ease of Use","description":"Participants responded to the Diabetes Injection Device - Preference Questionnaire (DID-PQ), Item 9 (ease of use) to compare the dulaglutide and semaglutide devices with regard to ease. Response options of \"strongly prefer\" and \"prefer\" were combined for each device, resulting in 3 categories: prefer dulaglutide, prefer semaglutide, and no preference. The Prescott test will be run to examine if a statistically significant difference in preference between the devices exists while, controlling for order effects.","timeFrame":"Day 1"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes\n* Self-injection naïve to all injectable treatment (for example, diabetes therapies and other medical conditions)\n* Injection naïve to performing all injectable treatment (for example, diabetes therapies and other medical conditions) to others\n\nExclusion Criteria:\n\n* Currently diagnosed with gestational diabetes and/or type 1 diabetes\n* Cognitive or physical difficulties that could interfere with ability to understand the training, perform the injection tasks, or complete the study questionnaires as judged by the investigator\n* Is a health care practitioner who is trained in giving injections","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Valley Research","city":"Fresno","state":"California","zip":"93720","country":"United States","geoPoint":{"lat":36.74773,"lon":-119.77237}},{"facility":"Long Beach Center for Clinical Research","city":"Long Beach","state":"California","zip":"90807","country":"United States","geoPoint":{"lat":33.76696,"lon":-118.18923}},{"facility":"Palm Harbor Medical Associates","city":"Palm Harbor","state":"Florida","zip":"34684","country":"United States","geoPoint":{"lat":28.07807,"lon":-82.76371}},{"facility":"Georgia Clinical Research","city":"Snellville","state":"Georgia","zip":"30078","country":"United States","geoPoint":{"lat":33.85733,"lon":-84.01991}},{"facility":"Cedar-Crosse Research Center","city":"Chicago","state":"Illinois","zip":"60607","country":"United States","geoPoint":{"lat":41.85003,"lon":-87.65005}},{"facility":"L-Marc Research Center","city":"Louisville","state":"Kentucky","zip":"40213","country":"United States","geoPoint":{"lat":38.25424,"lon":-85.75941}},{"facility":"Evidera","city":"Bethesda","state":"Maryland","zip":"20814","country":"United States","geoPoint":{"lat":38.98067,"lon":-77.10026}},{"facility":"Carolina Research Center, Inc.","city":"Shelby","state":"North Carolina","zip":"28150","country":"United States","geoPoint":{"lat":35.29235,"lon":-81.53565}},{"facility":"Lillestol Research LLC","city":"Fargo","state":"North Dakota","zip":"58104","country":"United States","geoPoint":{"lat":46.87719,"lon":-96.7898}},{"facility":"BRCR Medical Center, Inc.","city":"Camp Hill","state":"Pennsylvania","zip":"17011","country":"United States","geoPoint":{"lat":40.23981,"lon":-76.91997}},{"facility":"Juno Research","city":"Houston","state":"Texas","zip":"77040","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"Juno Research, LLC","city":"Houston","state":"Texas","zip":"77054","country":"United States","geoPoint":{"lat":29.76328,"lon":-95.36327}},{"facility":"PI-Coor Clinical Research, LLC","city":"Annandale","state":"Virginia","zip":"22003","country":"United States","geoPoint":{"lat":38.83039,"lon":-77.19637}},{"facility":"Manassas Clinical Research Center","city":"Manassas","state":"Virginia","zip":"20110","country":"United States","geoPoint":{"lat":38.75095,"lon":-77.47527}}]},"referencesModule":{"references":[{"pmid":"31646727","type":"BACKGROUND","citation":"Matza LS, Boye KS, Stewart KD, Coyne KS, Wullenweber PK, Cutts KN, Jordan JB, Wang Q, Yu M, Currie BM, Malley KG, Ishak KJ, Hietpas RT, Garcia-Perez LE. Assessing patient PREFERence between the dulaglutide pen and the semaglutide pen: A crossover study (PREFER). Diabetes Obes Metab. 2020 Mar;22(3):355-364. doi: 10.1111/dom.13902. Epub 2019 Dec 19."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.","accessCriteria":"A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.","url":"https://vivli.org/"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Injections with the 2 injection devices were performed on a practice pad.","groups":[{"id":"FG000","title":"Dulaglutide to Semaglutide","description":"Injection of commercial dulaglutide pen on a practice pad, then injection of commercial semaglutide pen on a practice pad."},{"id":"FG001","title":"Semaglutide to Dulaglutide","description":"Injection of commercial semaglutide pen on a practice pad, then injection of commercial dulaglutide pen on a practice pad."}],"periods":[{"title":"First Device","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"156"},{"groupId":"FG001","numSubjects":"156"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"155"},{"groupId":"FG001","numSubjects":"155"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]}]},{"title":"Second Device","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"155"},{"groupId":"FG001","numSubjects":"155"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"155"},{"groupId":"FG001","numSubjects":"155"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All Randomized participants.","groups":[{"id":"BG000","title":"Overall","description":"Participants were randomized to one of two treatment sequences: dulaglutide injection device to semaglutide injection device or semaglutide injection device to dulaglutide injection device."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"310"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"60.0","spread":"10.86"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"150"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"160"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"39"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"167"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"104"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"3"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"10"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"105"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"155"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"8"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"28"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"310"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Participant Preference Between 2 Injection Devices Based on Global Preference Item","description":"Preference of injection device was assessed by questionnaire which asks, \"Overall, which device do you prefer?\" The Prescott test will be run to examine if a statistically significant difference in preference between the devices exits, while controlling for order effects and taking into account the neutral responses.","populationDescription":"All randomized participants with exposure to both devices and Global Preference data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Day 1","groups":[{"id":"OG000","title":"Dulaglutide to Semaglutide","description":"Injection of commercial dulaglutide pen on a practice pad, then injection of semaglutide on a practice pad."},{"id":"OG001","title":"Semaglutide to Dulaglutide","description":"Injection of commercial semaglutide pen on a practice pad, then injection of commercial dulaglutide on a practice pad."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"155"}]}],"classes":[{"title":"Dulaglutide Device Preference","categories":[{"measurements":[{"groupId":"OG000","value":"87.7"},{"groupId":"OG001","value":"80.6"}]}]},{"title":"No Device Preference","categories":[{"measurements":[{"groupId":"OG000","value":"2.6"},{"groupId":"OG001","value":"4.5"}]}]},{"title":"Semaglutide Device Preference","categories":[{"measurements":[{"groupId":"OG000","value":"9.7"},{"groupId":"OG001","value":"14.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Prescott test"}]},{"type":"SECONDARY","title":"Participant Preference Between 2 Injection Devices Based on Ease of Use","description":"Participants responded to the Diabetes Injection Device - Preference Questionnaire (DID-PQ), Item 9 (ease of use) to compare the dulaglutide and semaglutide devices with regard to ease. 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The Prescott test will be run to examine if a statistically significant difference in preference between the devices exists while, controlling for order effects.","populationDescription":"All randomized participants with exposure to both devices and Ease of Use data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Day 1","groups":[{"id":"OG000","title":"Dulaglutide to Semaglutide","description":"Injection of commercial dulaglutide pen on a practice pad, then injection of commercial semaglutide pen on a practice pad."},{"id":"OG001","title":"Semaglutide to Dulaglutide","description":"Injection of commercial semaglutide pen on a practice pad, then injection of commercial dulaglutide pen on a practice pad."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"155"}]}],"classes":[{"title":"Dulaglutide Device Preference","categories":[{"measurements":[{"groupId":"OG000","value":"87.1"},{"groupId":"OG001","value":"86.5"}]}]},{"title":"No Device Preference","categories":[{"measurements":[{"groupId":"OG000","value":"5.2"},{"groupId":"OG001","value":"7.7"}]}]},{"title":"Semaglutide Device Preference","categories":[{"measurements":[{"groupId":"OG000","value":"7.7"},{"groupId":"OG001","value":"5.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Prescott test"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","description":"All cause mortality: All randomized participants with exposure to both devices. Safety: Zero participants analyzed. No safety data collected as injections were performed on a practice pad.","eventGroups":[{"id":"EG000","title":"Dulaglutide","description":"Injection of commercial dulaglutide pen on a practice pad.","deathsNumAffected":0,"deathsNumAtRisk":310,"seriousNumAffected":0,"seriousNumAtRisk":0,"otherNumAffected":0,"otherNumAtRisk":0},{"id":"EG001","title":"Semaglutide","description":"Injection of commercial semaglutide pen on a practice pad.","deathsNumAffected":0,"deathsNumAtRisk":310,"seriousNumAffected":0,"seriousNumAtRisk":0,"otherNumAffected":0,"otherNumAtRisk":0}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"GT60","restrictiveAgreement":true},"pointOfContact":{"title":"Chief Medical Officer","organization":"Eli Lilly and Company","email":"ClinicalTrials.gov@lilly.com","phone":"800-545-5979"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2018-11-30","uploadDate":"2020-04-09T08:20","filename":"Prot_000.pdf","size":5897851},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2018-10-09","uploadDate":"2020-04-09T08:21","filename":"SAP_001.pdf","size":427040}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"}],"ancestors":[{"id":"D003920","term":"Diabetes Mellitus"},{"id":"D044882","term":"Glucose Metabolism Disorders"},{"id":"D008659","term":"Metabolic Diseases"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"}]}},"hasResults":true}