{"protocolSection":{"identificationModule":{"nctId":"NCT04189848","orgStudyIdInfo":{"id":"NN9535-4648"},"secondaryIdInfos":[{"id":"2019-83003844-57","type":"REGISTRY","domain":"European Medicines Agency (EudraCT)"},{"id":"U1111-1241-0348","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2019","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2019"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc","officialTitle":"A Trial to Complare the Injection Site Pain Experience of Semaglutide 0.25 mg and Dulaglutide 0.75 mg Administered sc"},"statusModule":{"statusVerifiedDate":"2022-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-12-03","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-01-29","type":"ACTUAL"},"completionDateStruct":{"date":"2020-02-27","type":"ACTUAL"},"studyFirstSubmitDate":"2019-12-04","studyFirstSubmitQcDate":"2019-12-04","studyFirstPostDateStruct":{"date":"2019-12-06","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-01-28","resultsFirstSubmitQcDate":"2021-01-28","resultsFirstPostDateStruct":{"date":"2021-02-17","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-11-04","lastUpdatePostDateStruct":{"date":"2022-11-07","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This study in healthy men and women looks at the injection site experience of semaglutide and dulaglutide given subcutaneously (s.c., under the skin). Participants will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same day. The 2 injections will be given at least 30 minutes apart, one in each side of the stomach. Participants will be in the clinic research center for 1 day. A follow-up phone call will take place between 4 and 5 weeks after the injections were given."},"conditionsModule":{"conditions":["Healthy Volunteers","Diabetes Mellitus, Type 2","Overweight","Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":104,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide followed by dulaglutide","type":"EXPERIMENTAL","description":"The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach","interventionNames":["Drug: Semaglutide","Drug: Dulaglutide"]},{"label":"Dulaglutide followed by semaglutide","type":"EXPERIMENTAL","description":"The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach","interventionNames":["Drug: Semaglutide","Drug: Dulaglutide"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"Subjects will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same day.","armGroupLabels":["Dulaglutide followed by semaglutide","Semaglutide followed by dulaglutide"]},{"type":"DRUG","name":"Dulaglutide","description":"Subjects will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same day.","armGroupLabels":["Dulaglutide followed by semaglutide","Semaglutide followed by dulaglutide"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Intensity of Injection Site Pain","description":"The intensity of injection site pain was measured on a visual analogue scale (VAS). The VAS consists of a horizontal 100 millimeters (mm) line where 0 mm corresponded to no pain and 100 mm corresponded to unbearable pain. After each injection, the participants rated their pain perception at the VAS by marking a vertical line across the 100 mm horizontal line. The distance (mm) between the endpoint \"no pain\" and the vertical line on the VAS was recorded and analysed.","timeFrame":"1 minute after each injection (Day 1)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.\n* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.\n* Body mass index equal to or above 25.0 kg/m\\^2.\n* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the Investigator.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to trial product(s) or related products.\n* Previous participation in trial INS-4603, INS-4582 or NN9535-4648. Participation is defined as having received investigational product.\n* Female who is pregnant, breast-feeding or intends to become pregnant within 4 weeks of Day 1 or is of childbearing potential and not using highly effective contraceptive methods.\n* Participation in a drug study within 60 days prior to drug administration in the current trial OR participation in more than 4 other drug studies in the 12 months prior to drug administration in the current trial.\n* Any disorder which in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.\n* Glycosylated haemoglobin (HbA1c) equal to or above 6.5 % (48 mmol/mol) at screening.\n* Supine blood pressure at screening (after resting for 5 minutes or longer) outside the range of 90-160 mmHg for systolic or 45-89 mmHg for diastolic.\n* Supine pulse rate (as part of vital signs) outside the range of 40-100 beats/min after resting for 5 minutes or longer at screening.\n* Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, contraceptives and occasional use of paracetamol (not allowed within 24 hours prior to drug administration), within 14 days prior to Day 1.\n* Diagnostic test results positive for HIV-1 or HIV-2 infection.\n* Diagnostic test results positive for active hepatitis B or hepatitis C infection.\n* Mental incapacity, language barriers, or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or cooperation during the trial as judged by the Investigator.\n* Average intake of more than 21 units of alcohol per week for male subjects and more than 14 units per week for female subjects: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).\n* Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines \\[including ecstasy\\], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and admission to the clinical research centre.\n* Use of tobacco and nicotine products, defined as any of the below:\n* Smoking more than 1 cigarette or the equivalent per day on average.\n* Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house period.\n* Blood donation, plasma donation, or blood draw\n* In excess of 400 mL within the past 90 days prior to the day of screening\n* In excess of 50 mL within the past 30 days prior to the day of screening\n* Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.\n* Subjects with a history of malignant neoplasms within the past 5 years prior to screening will be excluded from the trial.\n* Presence or history of pancreatitis (acute or chronic; as declared by the subject or reported in the medical records).\n* Subject is not able to understand and read English or Dutch, or subject is not able to understand and comply with the trial requirements.\n* Subject depends on the Sponsor, the Investigator, or the study centre, or subject is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the trial.\n* Vulnerable subject (e.g. person kept in detention) who may have an increased likelihood of being wronged or of incurring additional harm.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Clinical Reporting Anchor and Disclosure (1452)","affiliation":"Novo Nordisk A/S","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Novo Nordisk Investigational Site","city":"Groningen","zip":"9728 NZ","country":"Netherlands","geoPoint":{"lat":53.21917,"lon":6.56667}}]},"referencesModule":{"references":[{"pmid":"33591618","type":"RESULT","citation":"Snitker S, Andersen A, Berg B, van Marle S, Sparre T. Comparison of the injection-site experience of the starting doses with semaglutide and dulaglutide: A randomized, double-blind trial in healthy subjects. Diabetes Obes Metab. 2021 Jun;23(6):1415-1419. doi: 10.1111/dom.14349. Epub 2021 Mar 18."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were randomised in a 2×2 scheme evenly to 4 sequences (A, B, C and D) of semaglutide product (Semaglutide 1.34 mg/mL PDS290 pre-filled pen-injector) or dulaglutide product (Trulicity 0.75 mg solution for injection in pre-filled pen) and side of injection (right/left) on abdomen.","recruitmentDetails":"The trial was conducted at one site in the Netherlands.","groups":[{"id":"FG000","title":"Sequence A: Semaglutide (Right) Then Dulaglutide (Left)","description":"Participants were to receive a subcutaneous (s.c.) injection of 0.25 milligrams (mg) of semaglutide on the right side of abdomen (in treatment period 1); followed by an s.c. injection of 0.75 mg of dulaglutide product on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other."},{"id":"FG001","title":"Sequence B: Semaglutide (Left) Then Dulaglutide (Right)","description":"Participants were to receive an s.c. injection of 0.25 mg of semaglutide on the left side of abdomen (in treatment period 1); followed by an s.c. injection of 0.75 mg of dulaglutide on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other."},{"id":"FG002","title":"Sequence C: Dulaglutide (Right) Then Semaglutide (Left)","description":"Participants were to receive an s.c. injection of 0.75 mg of dulaglutide on the right side of abdomen (in treatment period 1); followed by an s.c. injection of 0.25 mg of semaglutide on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other."},{"id":"FG003","title":"Sequence D: Dulaglutide (Left) Then Semaglutide (Right)","description":"Participants were to receive an s.c. injection of 0.75 mg of dulaglutide on the left side of abdomen (in treatment period 1); followed by an s.c. injection of 0.25 mg of semaglutide on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other."}],"periods":[{"title":"Treatment Period 1 (Day 1)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"25"},{"groupId":"FG003","numSubjects":"27"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"25"},{"groupId":"FG003","numSubjects":"27"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]},{"title":"Treatment Period 2 (Day 1)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"25"},{"groupId":"FG003","numSubjects":"27"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"25"},{"groupId":"FG003","numSubjects":"27"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) included all randomised subjects who had received at least 1 injection of semaglutide or dulaglutide (included any skin contact with trial product whether the injection was completed or not).","groups":[{"id":"BG000","title":"Overall Study","description":"Participants were to receive s.c. injections of 0.25 mg semaglutide and 0.75 mg dulaglutide each from any of the sequences A/B/C/D on Day 1. The 2 products were administered at least 30 minutes apart from each other."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"104"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"36.9","spread":"17.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"62"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"42"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"104"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Race","categories":[{"title":"White + Black or African","measurements":[{"groupId":"BG000","value":"5"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"3"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"94"}]},{"title":"White + Asian","measurements":[{"groupId":"BG000","value":"1"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Intensity of Injection Site Pain","description":"The intensity of injection site pain was measured on a visual analogue scale (VAS). The VAS consists of a horizontal 100 millimeters (mm) line where 0 mm corresponded to no pain and 100 mm corresponded to unbearable pain. After each injection, the participants rated their pain perception at the VAS by marking a vertical line across the 100 mm horizontal line. The distance (mm) between the endpoint \"no pain\" and the vertical line on the VAS was recorded and analysed.","populationDescription":"The per protocol (PP) set included all participants who had received both injections of semaglutide and dulaglutide and had completed both intensity of injection site pain assessments.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"1 minute after each injection (Day 1)","groups":[{"id":"OG000","title":"Semaglutide","description":"Participants were to receive an s.c. injection of 0.25 mg of semaglutide on either (left or right) sides of abdomen in any of the sequences A/B/C/D on Day 1."},{"id":"OG001","title":"Dulaglutide","description":"Participants were to receive an s.c. injection of 0.75 mg of dulaglutide on either (left or right) sides of abdomen in any of the sequences A/B/C/D on Day 1."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"104"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.6","spread":"10.1"},{"groupId":"OG001","value":"11.5","spread":"12.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Intensity of injection site pain was analysed by a fixed analysis of variance model with VAS pain score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.","nonInferiorityType":"OTHER","nonInferiorityComment":"Treatment comparison","pValue":"<0.0001","statisticalMethod":"ANOVA","paramType":"Treatment difference","paramValue":"-5.9","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-8.2","ciUpperLimit":"-3.6"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Day 1 to Day 28. Results are based on the safety analysis set which included all participants who had received at least 1 injection of semaglutide or dulaglutide (included any skin contact with trial product whether the injection was completed or not).","description":"All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset date on or after the day of first injection and no later than 28 days after the day of last injection. The trial was crossover and injections were given only 30 minutes apart. Therefore it was not possible to say which product the AE was related to. Hence, AE data are presented for the overall study.","eventGroups":[{"id":"EG000","title":"Overall Study","description":"Participants were to receive s.c. injections of 0.25 mg semaglutide and 0.75 mg dulaglutide each from any of the sequences A/B/C/D on Day 1. The 2 products were administered at least 30 minutes apart from each other.","deathsNumAffected":0,"deathsNumAtRisk":104,"seriousNumAffected":0,"seriousNumAtRisk":104,"otherNumAffected":34,"otherNumAtRisk":104}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":23,"numAffected":22,"numAtRisk":104}]},{"term":"Decreased Appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":12,"numAffected":12,"numAtRisk":104}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true,"otherDetails":"At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property."},"pointOfContact":{"title":"Clinical Reporting Anchor and Disclosure (1452)","organization":"Novo Nordisk A/S","email":"clinicaltrials@novonordisk.com","phone":"(+1) 866-867-7178"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2020-10-06","uploadDate":"2021-01-28T10:25","filename":"Prot_000.pdf","size":978781},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2020-10-06","uploadDate":"2021-01-28T10:32","filename":"SAP_001.pdf","size":602185}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003924","term":"Diabetes Mellitus, Type 2"},{"id":"D050177","term":"Overweight"},{"id":"D009765","term":"Obesity"}],"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"},{"id":"D044343","term":"Overnutrition"},{"id":"D009748","term":"Nutrition Disorders"},{"id":"D001835","term":"Body Weight"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"C000591245","term":"semaglutide"},{"id":"C555680","term":"dulaglutide"}]}},"hasResults":true}