Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-26 @ 3:17 AM
Study NCT ID:
NCT01640834
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2012-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of LY2409021 in Participants With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000601762', 'term': 'adomeglivant'}, {'id': 'D005934', 'term': 'Glucagon'}], 'ancestors': [{'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '100 mg LY2409021', 'description': 'LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.\n\nPlacebo: 2 capsules, administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.', 'otherNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '300 mg LY2409021', 'description': 'LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.', 'otherNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo: 3 capsules administered as a single oral dose on Day 2.\n\nGlucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 19, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 13, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg LY2409021', 'description': 'LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.\n\nPlacebo: 2 capsules, administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'OG001', 'title': '300 mg LY2409021', 'description': 'LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: 3 capsules administered as a single oral dose on Day 2.\n\nGlucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.85', 'spread': '7.15', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '9.63', 'groupId': 'OG001'}, {'value': '7.69', 'spread': '2.99', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0542', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.84', 'ciLowerLimit': '-11.82', 'ciUpperLimit': '0.14', 'groupDescription': "The mean change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 100-mg LY2409021 dose group using a 1 sample t-test.", 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0826', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.89', 'ciLowerLimit': '-14.95', 'ciUpperLimit': '1.16', 'groupDescription': "The mean change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group.", 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Day 2', 'description': 'The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.', 'unitOfMeasure': 'insulin units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of LY2409021 or placebo and had evaluable 24-hour insulin data.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg LY2409021', 'description': 'LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.\n\nPlacebo: 2 capsules, administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'OG001', 'title': '300 mg LY2409021', 'description': 'LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: 3 capsules administered as a single oral dose on Day 2.\n\nGlucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.71', 'spread': '19.90', 'groupId': 'OG000'}, {'value': '3.12', 'spread': '18.34', 'groupId': 'OG001'}, {'value': '22.75', 'spread': '22.20', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0460', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.0', 'ciLowerLimit': '-33.7', 'ciUpperLimit': '-0.4', 'groupDescription': "Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 100-mg LY2409021 dose group using a 1 sample t-test.", 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0192', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.6', 'ciLowerLimit': '-35.0', 'ciUpperLimit': '-4.3', 'groupDescription': "Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group using a 1 sample t-test.", 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Day 2', 'description': 'The percentage change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.', 'unitOfMeasure': 'percentage of insulin units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of LY2409021 or placebo and had evaluable 24-hour insulin data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg LY2409021', 'description': 'LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.\n\nPlacebo: 2 capsules, administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'OG001', 'title': '300 mg LY2409021', 'description': 'LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '2620', 'spread': '23', 'groupId': 'OG000'}, {'value': '6090', 'spread': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose (Day 2) through 120 hours postdose (Day 7)', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of LY2409021 and had evaluable pharmacokinetic data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg LY2409021', 'description': 'LY2409021: 100 milligrams (mg), capsule, administered as a single oral dose on Day 2.\n\nPlacebo: 2 capsules, administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'OG001', 'title': '300 mg LY2409021', 'description': 'LY2409021: 300 milligrams (mg), capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '209000', 'spread': '30', 'groupId': 'OG000'}, {'value': '506000', 'spread': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose (Day 2) through 120 hours postdose (Day 7)', 'description': 'Exposure in terms of AUC of LY2409021 from time 0 extrapolated to infinity (AUCinf) is reported.', 'unitOfMeasure': 'nanograms * hours per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of LY2409021 and had evaluable pharmacokinetic data.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose During Drug Washout Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg LY2409021', 'description': 'LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.\n\nPlacebo: 2 capsules, administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'OG001', 'title': '300 mg LY2409021', 'description': 'LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: 3 capsules administered as a single oral dose on Day 2.\n\nGlucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.'}], 'timeFrame': 'Baseline (Day 1), Day 3 up to Day 6', 'description': 'Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose Needed to Maintain Euglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg LY2409021', 'description': 'LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.\n\nPlacebo: 2 capsules, administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'OG001', 'title': '300 mg LY2409021', 'description': 'LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: 3 capsules administered as a single oral dose on Day 2.\n\nGlucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.'}], 'timeFrame': 'Baseline (Day 1), Day 3 up to Day 6', 'description': 'Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was not analyzed.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg LY2409021', 'description': 'LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.\n\nPlacebo: 2 capsules, administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'OG001', 'title': '300 mg LY2409021', 'description': 'LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: 3 capsules administered as a single oral dose on Day 2.\n\nGlucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '154.9', 'spread': '19', 'groupId': 'OG000'}, {'value': '141.3', 'spread': '19', 'groupId': 'OG001'}, {'value': '201.8', 'spread': '11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0187', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46', 'ciLowerLimit': '-82', 'ciUpperLimit': '-9', 'groupDescription': 'Statistical analysis of the effect of LY2409021 treatment on peak glucose concentration after an intramuscular injection of glucagon (1 milligram).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0048', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-59', 'ciLowerLimit': '-96', 'ciUpperLimit': '-23', 'groupDescription': 'Statistical analysis of the effect of LY2409021 treatment on peak glucose concentration after an intramuscular injection of glucagon (1 milligram).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 3', 'description': 'The Cmax of glucose following a single dose of glucagon (1 mg) administered via an intramuscular injection is reported.', 'unitOfMeasure': 'milligrams per deciliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of LY2409021 or placebo and had evaluable post-glucagon injection glucose concentration data.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg LY2409021', 'description': 'LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.\n\nPlacebo: 2 capsules, administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'OG001', 'title': '300 mg LY2409021', 'description': 'LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: 3 capsules administered as a single oral dose on Day 2.\n\nGlucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '15534.3', 'spread': '21', 'groupId': 'OG000'}, {'value': '14885.5', 'spread': '16', 'groupId': 'OG001'}, {'value': '20189.7', 'spread': '9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0278', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4423', 'ciLowerLimit': '-8256', 'ciUpperLimit': '-590', 'groupDescription': 'Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0046', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5187', 'ciLowerLimit': '-8371', 'ciUpperLimit': '-2004', 'groupDescription': 'Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 3', 'description': 'Area under the glucose concentration curve from time 0 through 2 hours after a single dose of glucagon (1 milligram) administered via an intramuscular injection is reported.', 'unitOfMeasure': 'milligrams * minutes per deciliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of LY2409021 or placebo and had evaluable post-glucagon injection glucose concentration data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '100 mg LY2409021', 'description': 'LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.\n\nPlacebo: 2 capsules, administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'FG001', 'title': '300 mg LY2409021', 'description': 'LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo: 3 capsules administered as a single oral dose on Day 2.\n\nGlucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '100 mg LY2409021', 'description': 'LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.\n\nPlacebo: 2 capsules, administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'BG001', 'title': '300 mg LY2409021', 'description': 'LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo: 3 capsules administered as a single oral dose on Day 2.\n\nGlucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '47.1', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '43.3', 'spread': '10.6', 'groupId': 'BG002'}, {'value': '43.0', 'spread': '10.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-24', 'studyFirstSubmitDate': '2012-07-12', 'resultsFirstSubmitDate': '2018-03-24', 'studyFirstSubmitQcDate': '2012-07-13', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-24', 'studyFirstPostDateStruct': {'date': '2012-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose', 'timeFrame': 'Baseline (Day 1), Day 2', 'description': 'The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin', 'timeFrame': 'Baseline (Day 1), Day 2', 'description': 'The percentage change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.'}, {'measure': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021', 'timeFrame': 'Predose (Day 2) through 120 hours postdose (Day 7)'}, {'measure': 'Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021', 'timeFrame': 'Predose (Day 2) through 120 hours postdose (Day 7)', 'description': 'Exposure in terms of AUC of LY2409021 from time 0 extrapolated to infinity (AUCinf) is reported.'}, {'measure': 'Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose During Drug Washout Period', 'timeFrame': 'Baseline (Day 1), Day 3 up to Day 6', 'description': 'Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.'}, {'measure': 'Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose Needed to Maintain Euglycemia', 'timeFrame': 'Baseline (Day 1), Day 3 up to Day 6', 'description': 'Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.'}, {'measure': 'Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3', 'timeFrame': 'Day 3', 'description': 'The Cmax of glucose following a single dose of glucagon (1 mg) administered via an intramuscular injection is reported.'}, {'measure': 'Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3', 'timeFrame': 'Day 3', 'description': 'Area under the glucose concentration curve from time 0 through 2 hours after a single dose of glucagon (1 milligram) administered via an intramuscular injection is reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'This study involves taking a single dose of 100 milligrams (mg) or 300 mg LY2409021 or placebo (an inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if this drug will reduce the amount of insulin a type 1 diabetic needs over 24 hours. This study includes a 7-day hospitalization period at the clinical research unit (CRU) and will involve screening within 30 days of the start of the study as well as telephone consultations within 5 days after discharge from the CRU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have had type 1 diabetes mellitus (T1DM) based on the World Health Organization classification for at least 1 year and have a daily insulin dose ≤1.5 international units (IU) per kilogram (kg) of body weight\n* Have a glycated hemoglobin A1c (HbA1c) of no greater than 9.0% as measured at screening\n* Have a body mass index (BMI) ≥19.0 and ≤35.0 kilograms per meter squared (kg/m\\^2)\n* Have given written informed consent approved by Lilly\n\nExclusion Criteria:\n\n* Received any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 3 months prior to screening\n* Have had more than 1 episode of severe hypoglycemia within 3 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness\n* Are pregnant or intend to become pregnant during the course of the study\n* Women who are breastfeeding\n* Have a history of stroke, myocardial infarction, heart failure, unstable angina, or a coronary revascularization procedure within 6 months of screening\n* Have fasting triglycerides \\>500 milligrams per deciliter (mg/dL) (5.65 millimoles per liter \\[mmol/L\\])\n* Have obvious clinical signs, symptoms, or laboratory evidence of liver disease (alanine transaminase \\[ALT\\] or aspartate transaminase \\[AST\\] greater than 2 times the upper limit of normal at screening)\n* Have a history of renal transplantation or are currently receiving renal dialysis or have a screening creatinine \\>2.0 mg/dL (177 micromoles per liter \\[μmol/L\\])\n* Have had any other disease, illness, or condition (including known diabetic autonomic neuropathy, drug or alcohol abuse, or psychiatric disorder) within the 6 months prior to screening that precludes the participant from following and completing the study or could increase their risk for hypoglycemia, according to the investigator's judgment\n* Are currently enrolled in, have completed, or have discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study"}, 'identificationModule': {'nctId': 'NCT01640834', 'briefTitle': 'Study of LY2409021 in Participants With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Pilot Study of the Effects of LY2409021 in Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '14576'}, 'secondaryIdInfos': [{'id': 'I1R-MC-GLBR', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2011-006178-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '100 mg LY2409021', 'description': 'LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2.\n\nPlacebo: 2 capsules, administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.', 'interventionNames': ['Drug: LY2409021', 'Drug: Placebo', 'Drug: Glucagon']}, {'type': 'EXPERIMENTAL', 'label': '300 mg LY2409021', 'description': 'LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.\n\nGlucagon: 1 mg administered via intramuscular injection on Day 3.', 'interventionNames': ['Drug: LY2409021', 'Drug: Glucagon']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo: 3 capsules administered as a single oral dose on Day 2.\n\nGlucagon: 1 milligram (mg) administered via intramuscular injection on Day 3.', 'interventionNames': ['Drug: Placebo', 'Drug: Glucagon']}], 'interventions': [{'name': 'LY2409021', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['100 mg LY2409021', '300 mg LY2409021']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['100 mg LY2409021', 'Placebo']}, {'name': 'Glucagon', 'type': 'DRUG', 'description': 'Administered via intramuscular injection', 'armGroupLabels': ['100 mg LY2409021', '300 mg LY2409021', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}