{"protocolSection":{"identificationModule":{"nctId":"NCT04143945","orgStudyIdInfo":{"id":"INS-4603"},"secondaryIdInfos":[{"id":"2019-003654-83","type":"REGISTRY","domain":"European Medicines Agency (EMA)"},{"id":"U1111-1239-7955","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":"A Study Comparing the Injection Site Pain Experience After the Injection of Semaglutide B and Semaglutide D With 2 Different Injection Pens, a Compound for the Treatment of Type 2 Diabetes and Obesity","officialTitle":"A Trial to Compare the Injection Site Pain Experience of 0.25 mg Semaglutide B and Semaglutide D Administered sc"},"statusModule":{"statusVerifiedDate":"2020-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-10-28","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-01-04","type":"ACTUAL"},"completionDateStruct":{"date":"2020-01-04","type":"ACTUAL"},"studyFirstSubmitDate":"2019-10-28","studyFirstSubmitQcDate":"2019-10-28","studyFirstPostDateStruct":{"date":"2019-10-30","type":"ACTUAL"},"resultsFirstSubmitDate":"2020-12-23","resultsFirstSubmitQcDate":"2020-12-23","resultsFirstPostDateStruct":{"date":"2021-01-20","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-12-23","lastUpdatePostDateStruct":{"date":"2021-01-20","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 the DV3396 pen to that of the PDS290 pens when both pens are used to deliver 0.25 mg semaglutide subcutaneously (s.c., under the skin). Participants will receive 2 single doses of semaglutide 0.25 mg on 1 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","Healthy Volunteers Overweight","Healthy Volunteers Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"CROSSOVER","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","maskingDescription":"Sponsor staff involved in the clinical trial is masked according to company standard procedures","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":104,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"DV3396 followed by PDS290","type":"EXPERIMENTAL","description":"The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach","interventionNames":["Drug: Semaglutide (administered by DV3396 pen)","Drug: Semaglutide (administered by PDS290 pen)"]},{"label":"PDS290 followed by DV3396","type":"EXPERIMENTAL","description":"The 2 treatments will be administered at least 30 minutes apart, one in each side of the stomach","interventionNames":["Drug: Semaglutide (administered by DV3396 pen)","Drug: Semaglutide (administered by PDS290 pen)"]}],"interventions":[{"type":"DRUG","name":"Semaglutide (administered by DV3396 pen)","description":"Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day","armGroupLabels":["DV3396 followed by PDS290","PDS290 followed by DV3396"]},{"type":"DRUG","name":"Semaglutide (administered by PDS290 pen)","description":"Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day","armGroupLabels":["DV3396 followed by PDS290","PDS290 followed by DV3396"]}]},"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 millimetres (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 line. The distance (mm) between the endpoint \"no pain\" and the vertical line on the VAS was recorded and analysed.","timeFrame":"After 1 minute of each injection (Day 1)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.\n* Male or female subjects, aged 18 to 75 years (both inclusive) at the time of signing informed consent.\n* BMI 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-4604 or INS-4582. 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 child-bearing potential and not using highly effective contraceptive methods.\n* Participation in a drug study within 60 days prior to drug administration in the current study OR participation in more than 4 other drug studies in the 12 months prior to drug administration in the current study.\n* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.\n* Glycosylated hemoglobin (HbA1c) equal to or above 6.5 % (48 mmol/mol) at screening.\n* Supine blood pressure at screening (after resting for 5 min 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\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 study\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 study requirements\n* Subject depends on the sponsor, the investigator, or the study center, 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":"35434913","type":"DERIVED","citation":"Snitker S, Andersen A, Lindskov PS, van Marle S, Sode BF, Sparre T. Comparison of the injection-site experience of semaglutide in a single-dose and a multidose pen-injector. Diabetes Obes Metab. 2022 Aug;24(8):1643-1646. doi: 10.1111/dom.14718. Epub 2022 May 20. No abstract available."}]},"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 either DV3396 or PDS290 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: DV3396 (Right) Then PDS290 (Left)","description":"Participants were to receive a subcutaneous (s.c.) injection of DV3396 product (0.25 milligrams (mg) of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (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":"FG001","title":"Sequence B: DV3396 (Left) Then PDS290 (Right)","description":"Participants were to receive an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (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."},{"id":"FG002","title":"Sequence C: PDS290 (Right) Then DV3396 (Left)","description":"Participants were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (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: PDS290 (Left) Then DV3396 (Right)","description":"Participants were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (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":"26"},{"groupId":"FG003","numSubjects":"26"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"26"},{"groupId":"FG003","numSubjects":"26"}]},{"type":"Safety Analysis Set (SAS)","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"26"},{"groupId":"FG003","numSubjects":"26"}]},{"type":"Per Protocol Set","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"26"},{"groupId":"FG003","numSubjects":"26"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"26"},{"groupId":"FG003","numSubjects":"26"}]},{"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":"26"},{"groupId":"FG003","numSubjects":"26"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"26"},{"groupId":"FG003","numSubjects":"26"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The full analysis set included all participants who had received at least 1 injection of semaglutide (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 2 s.c. injections of 0.25 mg semaglutide; 1 each of PDS290 product and DV3396 product 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":"39.1","spread":"18.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"59"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"45"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"103"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"American Indian or Alaska Native","categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}]},{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}]},{"title":"Black or African American","categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}]},{"title":"Native Hawaiian or other Pacific Islander","categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}]},{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"100"}]}]},{"title":"White + Black or African American","categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}]},{"title":"White + Asian","categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}]},{"title":"Asian + Black or African American","categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}]},{"title":"Other","categories":[{"measurements":[{"groupId":"BG000","value":"0"}]}]}]}]},"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 millimetres (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 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 had completed both intensity of injection site pain assessments.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"After 1 minute of each injection (Day 1)","groups":[{"id":"OG000","title":"DV3396","description":"Participants were to receive a s.c. injection of DV3396 product (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":"PDS290","description":"Participants were to receive a s.c. injection of PDS290 product (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."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"104"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.3","spread":"12.9"},{"groupId":"OG001","value":"5.7","spread":"9.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The intensity of 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":"Comparison","pValue":"0.0395","statisticalMethod":"ANOVA","paramType":"Estimated treatment difference","paramValue":"2.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.1","ciUpperLimit":"5.1"}]}]},"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 (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 2 s.c. injections of 0.25 mg semaglutide; 1 each of PDS290 product and DV3396 product 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":28,"otherNumAtRisk":104}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":18,"numAffected":17,"numAtRisk":104}]},{"term":"Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":12,"numAffected":11,"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":"2020-08-26","uploadDate":"2020-12-23T08:15","filename":"Prot_000.pdf","size":16798765},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2020-08-26","uploadDate":"2020-12-23T08:15","filename":"SAP_001.pdf","size":783706}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"interventionBrowseModule":{"meshes":[{"id":"C000591245","term":"semaglutide"}]}},"hasResults":true}