Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 5:56 PM
Study NCT ID:
NCT01680328
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2012-08-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'Novo Nordisk reserves the right to defer the release of data until specified milestones are reached, for example when the clinical trial report is available. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Day 0 when receiving 19 injections and up to 48 hours after last injection.', 'description': 'All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the safety analysis set.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.', 'otherNumAtRisk': 82, 'otherNumAffected': 0, 'seriousNumAtRisk': 82, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Injection Pain (VAS mm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '82', 'groupId': 'OG005'}, {'value': '82', 'groupId': 'OG006'}, {'value': '82', 'groupId': 'OG007'}, {'value': '82', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Thighs: Injection Region-5 s.c Injections+1 Needle Insertion', 'description': 'Pain (VAS) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.'}, {'id': 'OG001', 'title': 'Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion', 'description': 'Pain (VAS) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.'}, {'id': 'OG002', 'title': 'Injection Volume 1600 μL', 'description': 'Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG003', 'title': 'Injection Volume 1200 μL', 'description': 'Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG004', 'title': 'Injection Volume 800 μL', 'description': 'Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG005', 'title': 'Injection Volume 400 μL', 'description': 'Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG006', 'title': 'Injection Speed at 450 μL/s', 'description': 'Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG007', 'title': 'Injection Speed at 300 μL/s', 'description': 'Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG008', 'title': 'Injection Speed at 150 μL/s', 'description': 'Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}], 'classes': [{'title': 'Needle insertion', 'categories': [{'measurements': [{'value': '20.0', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '16.3', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG008'}]}]}, {'title': 'Injection speed at 150 μL/s; Abdomen', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG001'}, {'value': '20.9', 'spread': '24.4', 'groupId': 'OG002'}, {'value': '15.7', 'spread': '20.2', 'groupId': 'OG003'}, {'value': '11.6', 'spread': '15.7', 'groupId': 'OG004'}, {'value': '14.5', 'spread': '17.3', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No summary statistics done for this combination', 'groupId': 'OG008'}]}]}, {'title': 'Injection speed at 300 μL/s; Abdomen', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG001'}, {'value': '17.2', 'spread': '22.5', 'groupId': 'OG002'}, {'value': '20.1', 'spread': '25.3', 'groupId': 'OG003'}, {'value': '13.7', 'spread': '17.1', 'groupId': 'OG004'}, {'value': '14.8', 'spread': '18.1', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No summary statistics done for this combination', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG008'}]}]}, {'title': 'Injection speed at 450 μL/s; Abdomen', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG001'}, {'value': '21.1', 'spread': '24.8', 'groupId': 'OG002'}, {'value': '14.9', 'spread': '16.9', 'groupId': 'OG003'}, {'value': '14.8', 'spread': '18.9', 'groupId': 'OG004'}, {'value': '12.4', 'spread': '15.5', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No summary statistics done for this combination', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG008'}]}]}, {'title': 'Injection volume of 400 μL; Thighs', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No summary statistics done for this combination', 'groupId': 'OG005'}, {'value': '20.9', 'spread': '24.8', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG007'}, {'value': '22.9', 'spread': '25.9', 'groupId': 'OG008'}]}]}, {'title': 'Injection volume of 800 μL; Thighs', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No summary statistics done for this combination', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG006'}, {'value': '23.2', 'spread': '24.5', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG008'}]}]}, {'title': 'Injection volume of 1600 μL; Thighs', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No summary statistics done for this combination', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG005'}, {'value': '31.1', 'spread': '28.5', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG007'}, {'value': '31.5', 'spread': '28.0', 'groupId': 'OG008'}]}]}], 'analyses': [{'groupIds': ['OG004', 'OG005'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '2.8', 'groupDescription': 'Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '0.4', 'ciUpperLimit': '6.6', 'groupDescription': 'Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG005'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '7.2', 'ciLowerLimit': '4.6', 'ciUpperLimit': '9.7', 'groupDescription': 'Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '0.4', 'ciUpperLimit': '6.7', 'groupDescription': 'Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '7.2', 'ciLowerLimit': '4.4', 'ciUpperLimit': '10.0', 'groupDescription': 'Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '3.7', 'ciLowerLimit': '0.6', 'ciUpperLimit': '6.7', 'groupDescription': 'Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG007', 'OG008'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '2.9', 'groupDescription': 'Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean difference in injection pain on VAS after injection at different speeds was calculated as least square mean estimate of the mean difference in injection pain on a VAS after injection at different speeds.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG006', 'OG008'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '1.9', 'groupDescription': 'Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean difference in injection pain on VAS after injection at different speeds was calculated as least square mean estimate of the mean difference in injection pain on a VAS after injection at different speeds.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '9.0', 'ciLowerLimit': '6.7', 'ciUpperLimit': '11.3', 'groupDescription': 'Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. The mean difference in injection pain on a VAS (mm) between the thighs and abdomen was calculated as the least square mean estimate of the mean difference in injection pain on a VAS (mm) between the thighs and abdomen.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 minute (±30 sec) after each injection', 'description': 'Calculated as the least square mean estimate of the difference in injection pain on a VAS (mm) between different factor levels corresponding to injection region, injection volume and injection speed (pain was assessed using an electronic VAS consisting of a 100 mm line where 0 mm corresponded to no pain and 100 mm corresponded to worst pain. After each injection, the subjects rated their pain perception at the electronic VAS by marking the 100 mm line).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. A total of 4 subjects did not contribute to the analysis due to missing injections (2) and missing VAS evaluation (2).'}, {'type': 'SECONDARY', 'title': 'Acceptance of Injection Pain After Injection of Different Volumes.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Injection Volume of 1600 μL', 'description': 'Acceptance of pain was assessed in each subject for all injections.'}, {'id': 'OG001', 'title': 'Injection Volume of 1200 μL', 'description': 'Acceptance of pain was assessed in each subject for all injections.'}, {'id': 'OG002', 'title': 'Injection Volume of 800 μL', 'description': 'Acceptance of pain was assessed in each subject for all injections.'}, {'id': 'OG003', 'title': 'Injection Volume of 400 μL', 'description': 'Acceptance of pain was assessed in each subject for all injections.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '334', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '303', 'groupId': 'OG002'}, {'value': '368', 'groupId': 'OG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.4', 'groupDescription': "Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.", 'statisticalMethod': 'Odds ratio (OR)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '1.2', 'ciUpperLimit': '3.5', 'groupDescription': "Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '1.4', 'ciUpperLimit': '3.0', 'groupDescription': "Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '1.4', 'ciUpperLimit': '4.8', 'groupDescription': "Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '1.4', 'ciUpperLimit': '4.6', 'groupDescription': "Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.7', 'ciUpperLimit': '1.5', 'groupDescription': "Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 minute (±30 seconds) after each injection', 'description': 'Acceptance of pain was rated subjectively as yes or no by the subject after each injection.', 'unitOfMeasure': 'scores', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Acceptance of Injection Pain After Injection at Different Speeds.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Injection Speed at 450 μL/s', 'description': 'Acceptance of pain was assessed in each subject for all injections.'}, {'id': 'OG001', 'title': 'Injection Speed at 300 μL/s', 'description': 'Acceptance of pain was assessed in each subject for all injections.'}, {'id': 'OG002', 'title': 'Injection Speed at 150 μL/s', 'description': 'Acceptance of pain was assessed in each subject for all injections.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '432', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}, {'value': '426', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.7', 'ciUpperLimit': '1.8', 'groupDescription': "Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'higher speed versus lower', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the higher speed - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.6', 'ciUpperLimit': '1.2', 'groupDescription': "Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'higher speed versus lower', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the higher speed - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 minute (±30 sec) after each injection', 'description': 'Acceptance of pain was rated subjectively as yes or no by the subject after each injection.', 'unitOfMeasure': 'scores', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Thighs', 'description': 'Acceptance of pain was assessed in each subject for all injections in the thighs.'}, {'id': 'OG001', 'title': 'Abdomen', 'description': 'Acceptance of pain was assessed in each subject for all injections in the abdomen.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '390', 'groupId': 'OG000'}, {'value': '978', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '3.7', 'ciLowerLimit': '2.4', 'ciUpperLimit': '5.5', 'groupDescription': "Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain in the thighs - i.e. a worse condition.", 'statisticalMethod': 'Odds ratio (OR)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 minute (±30 seconds) after each injection', 'description': 'Acceptance of pain was rated subjectively as yes or no by the subject after each injection.', 'unitOfMeasure': 'scores', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '82', 'groupId': 'OG005'}, {'value': '82', 'groupId': 'OG006'}, {'value': '82', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion', 'description': 'Backflow (uL) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.'}, {'id': 'OG001', 'title': 'Injection Volume 1600 μL', 'description': 'Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG002', 'title': 'Injection Volume 1200 μL', 'description': 'Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG003', 'title': 'Injection Volume 800 μL', 'description': 'Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG004', 'title': 'Injection Volume 400 μL', 'description': 'Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG005', 'title': 'Injection Speed at 450 μL/s', 'description': 'Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG006', 'title': 'Injection Speed at 300 μL/s', 'description': 'Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG007', 'title': 'Injection Speed at 150 μL/s', 'description': 'Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}], 'classes': [{'title': 'Needle insertion', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG007'}]}]}, {'title': 'Injection speed at 150 μL/s', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.9', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '1.4', 'groupId': 'OG003'}, {'value': '0.6', 'spread': '1.8', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No summary statistics done for this combination', 'groupId': 'OG007'}]}]}, {'title': 'Injection speed at 300 μL/s', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.9', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '1.6', 'groupId': 'OG003'}, {'value': '0.4', 'spread': '1.3', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No summary statistics done for this combination', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG007'}]}]}, {'title': 'Injection speed at 450 μL/s', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '4.6', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '1.3', 'groupId': 'OG003'}, {'value': '0.9', 'spread': '2.7', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No summary statistics done for this combination', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG007'}]}]}], 'analyses': [{'groupIds': ['OG004', 'OG007'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.8', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG006'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '1.6', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '2.1', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003', 'OG007'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '1.7', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003', 'OG006'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '1.7', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '1.8', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG007'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '2.1', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG006'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '2.0', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG005'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '2.3', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG007'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '1.0', 'ciUpperLimit': '3.5', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG006'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '0.2', 'ciUpperLimit': '2.6', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG005'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.8', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 minutes (±30sec) after each injection', 'description': 'Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.', 'unitOfMeasure': 'mcL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. One subject did not contribute to the analysis due to missing injection.'}, {'type': 'SECONDARY', 'title': 'Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}, {'value': '82', 'groupId': 'OG004'}, {'value': '82', 'groupId': 'OG005'}, {'value': '82', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Thighs: Injection Region-5 s.c Injections+1 Needle Insertion', 'description': 'Backflow (uL) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.'}, {'id': 'OG001', 'title': 'Injection Volume 1600 μL', 'description': 'Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG002', 'title': 'Injection Volume 800 μL', 'description': 'Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG003', 'title': 'Injection Volume 400 μL', 'description': 'Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG004', 'title': 'Injection Speed at 450 μL/s', 'description': 'Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG005', 'title': 'Injection Speed at 300 μL/s', 'description': 'Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}, {'id': 'OG006', 'title': 'Injection Speed at 150 μL/s', 'description': 'Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).'}], 'classes': [{'title': 'Needle insertion', 'categories': [{'measurements': [{'value': '0.8', 'spread': '5.6', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG006'}]}]}, {'title': 'Injection speed at 150 μL/s', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '8.6', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '3.1', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No summary statistics done for this combination.', 'groupId': 'OG006'}]}]}, {'title': 'Injection speed at 300 μL/s', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '7.9', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Summary statistics is same as presented in Injection speed at 300 μL/s x Injection Volume 800 μL.', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG006'}]}]}, {'title': 'Injection speed at 450 μL/s', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '4.6', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '4.9', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No summary statistics done for this combination.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not administered', 'groupId': 'OG006'}]}]}], 'analyses': [{'groupIds': ['OG003', 'OG006'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '1.5', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '2.1', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG005'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '0.3', 'ciUpperLimit': '2.8', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG006'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '4.9', 'ciLowerLimit': '3.7', 'ciUpperLimit': '6.1', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Least Square Mean Difference', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '0.5', 'ciUpperLimit': '2.9', 'groupDescription': 'Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 minutes (±30sec) after each injection', 'description': 'Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.', 'unitOfMeasure': 'mcL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. One subject did not contribute to the analysis due to missing injection.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}]}, {'type': 'Subjects Missing Injections', 'achievements': [{'comment': 'One missed the \\[1600 μL, 450 μL/s; thighs\\]; one missed the \\[400 μL, 300 μL/s; abdomen\\]', 'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The trial was conducted at a single site in Germany at a single visit.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'spread': '11.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-18', 'studyFirstSubmitDate': '2012-08-31', 'resultsFirstSubmitDate': '2013-12-06', 'studyFirstSubmitQcDate': '2012-09-06', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-05-19', 'studyFirstPostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Injection Pain (VAS mm)', 'timeFrame': '1 minute (±30 sec) after each injection', 'description': 'Calculated as the least square mean estimate of the difference in injection pain on a VAS (mm) between different factor levels corresponding to injection region, injection volume and injection speed (pain was assessed using an electronic VAS consisting of a 100 mm line where 0 mm corresponded to no pain and 100 mm corresponded to worst pain. After each injection, the subjects rated their pain perception at the electronic VAS by marking the 100 mm line).'}], 'secondaryOutcomes': [{'measure': 'Acceptance of Injection Pain After Injection of Different Volumes.', 'timeFrame': '1 minute (±30 seconds) after each injection', 'description': 'Acceptance of pain was rated subjectively as yes or no by the subject after each injection.'}, {'measure': 'Acceptance of Injection Pain After Injection at Different Speeds.', 'timeFrame': '1 minute (±30 sec) after each injection', 'description': 'Acceptance of pain was rated subjectively as yes or no by the subject after each injection.'}, {'measure': 'Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen.', 'timeFrame': '1 minute (±30 seconds) after each injection', 'description': 'Acceptance of pain was rated subjectively as yes or no by the subject after each injection.'}, {'measure': 'Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion', 'timeFrame': '2 minutes (±30sec) after each injection', 'description': 'Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.'}, {'measure': 'Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion', 'timeFrame': '2 minutes (±30sec) after each injection', 'description': 'Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2', 'Delivery Systems']}, 'referencesModule': {'references': [{'pmid': '24720741', 'type': 'RESULT', 'citation': 'Heise T, Nosek L, Dellweg S, Zijlstra E, Praestmark KA, Kildegaard J, Nielsen G, Sparre T. Impact of injection speed and volume on perceived pain during subcutaneous injections into the abdomen and thigh: a single-centre, randomized controlled trial. Diabetes Obes Metab. 2014 Oct;16(10):971-6. doi: 10.1111/dom.12304. Epub 2014 May 11.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of this trial is to assess and describe the pain in relation to subcutaneous (under the skin) injection of different combinations of injection speed and volume with respect to acceptance of the injection pain and backflow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities.\n* Type 1 or type 2 diabetes\n* Daily injection(s) with anti-diabetic drug (insulin or Glucagon like Peptide-1 (GLP-1) analogues) via pen-injector or vial/syringe for more than 6 months\n* Body mass index (BMI) between 18.5 and 30.0 kg/m\\^2 (both included)\n* Caucasians\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit\n* Previous participation in this trial. Participation is defined as: screened\n* Receipt of any investigational medicinal product that can influence pain perception within 14 days before screening\n* Injection of more than 40 units of insulin per injection\n* Continuous Subcutaneous Insulin Infusion use within the last 6 months\n* Continuous Glucose Monitoring use within the last 6 months\n* Intake of any pain-relieving or analgesic within the last week (excluding low dose aspirin in cardio vascular prophylactic doses)\n* Known active or in-active skin disease in the injection area or that may affect pain perception\n* Anti-coagulant treatment within the last month (low dose of aspirin in cardiovascular prophylactic doses is allowed. However, not on the day of the injections)'}, 'identificationModule': {'nctId': 'NCT01680328', 'briefTitle': 'Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations', 'orgStudyIdInfo': {'id': 'INS-4011'}, 'secondaryIdInfos': [{'id': 'U1111-1129-4191', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Different injection speed and volume combinations', 'description': 'The study consists of 80 treatment arms in a cross-over design with 19 treatments and 19 periods. The 80 treatment arms will represent different orders of the 19 treatments and each treatment arm will be used for one subject. A subject not completing all treatments will be replaced by another subject using the same treatment arm.', 'interventionNames': ['Other: 19 injections', 'Drug: sodium chloride 0.9% solution']}], 'interventions': [{'name': '19 injections', 'type': 'OTHER', 'description': 'Subjects will receive 19 injections in randomised order of which 13 will be in the abdomen and 6 in the thighs. Out of the 19 injections, 2 are needle insertions only. The remaining 17 injections represent different combinations of injection speed and volume of sodium chloride 0.9% solution for injection. The order of the injection speed and volume combinations will be blinded for the subject and the pain will be evaluated by the subject on a VAS (Visual Analogue Scale).', 'armGroupLabels': ['Different injection speed and volume combinations']}, {'name': 'sodium chloride 0.9% solution', 'type': 'DRUG', 'description': 'Solution for injection.', 'armGroupLabels': ['Different injection speed and volume combinations']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}