Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-29 @ 4:24 AM
Study NCT ID:
NCT01769404
Status:
COMPLETED
Last Update Posted:
2019-06-24
First Post:
2013-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of LY2605541 and Glargine 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': 'C587357', 'term': 'LY2605541'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'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': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: 0.2-0.6 U/kg LY2605541', 'description': 'Participants received a stable dose of LY2605541 (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in Treatment Period 1 or 2. Dose based on prestudy basal insulin dosing regimen.', 'otherNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1: 0.2-0.6 U/kg Insulin Glargine', 'description': 'Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in Treatment Period 1 or 2. Dose based on prestudy basal insulin dosing regimen.', 'otherNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 2: 0.2-0.6 U/kg LY2605541', 'description': 'Participants received a stable dose of LY2605541 (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in Treatment Period 1 or 2. Dose based on prestudy basal insulin dosing regimen.', 'otherNumAtRisk': 13, 'otherNumAffected': 1, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 2: 0.2-0.6 U/kg Insulin Glargine', 'description': 'Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in Treatment Period 1 or 2. Dose based on prestudy basal insulin dosing regimen.', 'otherNumAtRisk': 13, 'otherNumAffected': 3, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Concentration of Epinephrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'Participants received a stable dose of LY2605541 (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '157.2', 'spread': '90.9', 'groupId': 'OG000'}, {'value': '196.5', 'spread': '207.0', 'groupId': 'OG001'}]}]}, {'title': 'BG nadir', 'categories': [{'measurements': [{'value': '607.5', 'spread': '281.0', 'groupId': 'OG000'}, {'value': '525.2', 'spread': '305.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp', 'description': "Epinephrine levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at blood glucose (BG) level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value.", 'unitOfMeasure': 'picomole per liter (pmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2 who received at least 1 dose of study drug with evaluable epinephrine data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.'}, {'type': 'SECONDARY', 'title': 'Amount of Glucose Required to Reach Blood Glucose (BG) of 72 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'Participants received a stable dose of LY2605541 (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '11600', 'spread': '37', 'groupId': 'OG000'}, {'value': '12700', 'spread': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp', 'description': 'The amount of infused glucose required to reach BG of 72 milligrams per deciliter (mg/dL) is presented.', 'unitOfMeasure': 'milligrams (mg)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2 who received at least 1 dose of study drug with evaluable BG data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.'}, {'type': 'SECONDARY', 'title': 'Amount of Glucose Required to Maintain BG of 72 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'Participants received a stable dose of LY2605541 (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '15400', 'spread': '34', 'groupId': 'OG000'}, {'value': '15900', 'spread': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp', 'description': 'The amount of infused glucose required to maintain BG of 72 mg/dL for 1 hour is presented.', 'unitOfMeasure': 'mg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2 who received at least 1 dose of study drug with evaluable BG data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cortisol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'Participants received a stable dose of LY2605541 (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '206.7', 'spread': '75.4', 'groupId': 'OG000'}, {'value': '260.0', 'spread': '92.4', 'groupId': 'OG001'}]}]}, {'title': 'BG nadir', 'categories': [{'measurements': [{'value': '337.3', 'spread': '121.2', 'groupId': 'OG000'}, {'value': '333.8', 'spread': '74.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp', 'description': "Cortisol levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.", 'unitOfMeasure': 'nanomole per liter (nmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2 who received at least 1 dose of study drug with evaluable cortisol data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.'}, {'type': 'SECONDARY', 'title': 'Concentration of Glucagon', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'Participants received a stable dose of LY2605541 (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.02', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '5.28', 'spread': '2.46', 'groupId': 'OG001'}]}]}, {'title': 'BG nadir', 'categories': [{'measurements': [{'value': '5.89', 'spread': '2.82', 'groupId': 'OG000'}, {'value': '4.98', 'spread': '2.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp', 'description': "Glucagon levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.", 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2 who received at least 1 dose of study drug with evaluable glucagon data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.'}, {'type': 'SECONDARY', 'title': 'Concentration of Growth Hormone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'Participants received a stable dose of LY2605541 (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.0816', 'spread': '2.5527', 'groupId': 'OG000'}, {'value': '1.3948', 'spread': '1.3981', 'groupId': 'OG001'}]}]}, {'title': 'BG nadir', 'categories': [{'measurements': [{'value': '6.8752', 'spread': '6.7187', 'groupId': 'OG000'}, {'value': '8.0114', 'spread': '9.9621', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp', 'description': "Growth hormone levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.", 'unitOfMeasure': 'micrograms per liter (µg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2 who received at least 1 dose of study drug with evaluable growth hormone data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.'}, {'type': 'SECONDARY', 'title': 'Concentration of Norepinephrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2605541', 'description': 'Participants received a stable dose of LY2605541 (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received a stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days. Dose based on prestudy basal insulin dosing regimen.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1004.2', 'spread': '358.2', 'groupId': 'OG000'}, {'value': '1139.8', 'spread': '603.2', 'groupId': 'OG001'}]}]}, {'title': 'BG nadir', 'categories': [{'measurements': [{'value': '1235.8', 'spread': '422.8', 'groupId': 'OG000'}, {'value': '1434.8', 'spread': '933.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp', 'description': "Norepinephrine values are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value.", 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Cohort 2 who received at least 1 dose of study drug with evaluable norepinephrine data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1 (LY2605541, Then Insulin Glargine)', 'description': 'Participants received a stable dose of 0.2 to 0.6 U/kg LY2605541, administered subcutaneously (SQ), once daily for 14 days in Treatment Period 1, followed by a stable dose of 0.2 to 0.6 U/kg insulin glargine, administered SQ, once daily for 14 days in Treatment Period 2.'}, {'id': 'FG001', 'title': 'Cohort 2 (Insulin Glargine, Then LY2605541)', 'description': 'Participants received a stable dose of 0.2 to 0.6 U/kg insulin glargine, administered SQ, once daily for 14 days in Treatment Period 1, followed by a stable dose of 0.2 to 0.6 U/kg LY2605541, administered SQ, once daily for 14 days in Treatment Period 2.'}], 'periods': [{'title': 'Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Did not meet eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants who received at least 1 dose of study drug.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '10.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-27', 'studyFirstSubmitDate': '2013-01-14', 'resultsFirstSubmitDate': '2018-03-17', 'studyFirstSubmitQcDate': '2013-01-14', 'lastUpdatePostDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-27', 'studyFirstPostDateStruct': {'date': '2013-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of Epinephrine', 'timeFrame': '30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp', 'description': "Epinephrine levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at blood glucose (BG) level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value."}], 'secondaryOutcomes': [{'measure': 'Amount of Glucose Required to Reach Blood Glucose (BG) of 72 mg/dL', 'timeFrame': '30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp', 'description': 'The amount of infused glucose required to reach BG of 72 milligrams per deciliter (mg/dL) is presented.'}, {'measure': 'Amount of Glucose Required to Maintain BG of 72 mg/dL', 'timeFrame': '30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp', 'description': 'The amount of infused glucose required to maintain BG of 72 mg/dL for 1 hour is presented.'}, {'measure': 'Concentration of Cortisol', 'timeFrame': '30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp', 'description': "Cortisol levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value."}, {'measure': 'Concentration of Glucagon', 'timeFrame': '30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp', 'description': "Glucagon levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value."}, {'measure': 'Concentration of Growth Hormone', 'timeFrame': '30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp', 'description': "Growth hormone levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value."}, {'measure': 'Concentration of Norepinephrine', 'timeFrame': '30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp', 'description': "Norepinephrine values are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'This study has 2 parts. Each participant will receive a daily injection of LY2605541 during one treatment period and a daily injection of insulin glargine during one treatment period. Each treatment period is 2 to 3 weeks and is followed by a procedure to lower blood sugar levels to see how the body recovers after each treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) less than 9%\n* Otherwise fit and healthy\n* Nonsmoker\n\nExclusion Criteria:\n\n* Taking medication or supplements other than insulin to control diabetes\n* Suffered a hypoglycemic event in the last 12 months that required hospitalization or has poor awareness of hypoglycemia'}, 'identificationModule': {'nctId': 'NCT01769404', 'briefTitle': 'A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Evaluation of the Counter-Regulatory Response to Hypoglycaemia Following LY2605541 Administration Compared to Insulin Glargine in Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '14870'}, 'secondaryIdInfos': [{'id': 'I2R-MC-BIDM', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY2605541', 'description': 'Stable dose of LY2605541 (0.2 to 0.6 units per kilogram \\[U/kg\\]) administered subcutaneously (SQ) once daily for at least 14 days in 1 of 2 treatment periods. Dose based on prestudy basal insulin dosing regimen.', 'interventionNames': ['Biological: LY2605541']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Glargine', 'description': 'Stable dose of insulin glargine (0.2 to 0.6 U/kg) administered SQ once daily for at least 14 days in 1 of 2 treatment periods. Dose based on prestudy basal insulin dosing regimen.', 'interventionNames': ['Biological: Insulin Glargine']}], 'interventions': [{'name': 'LY2605541', 'type': 'BIOLOGICAL', 'armGroupLabels': ['LY2605541']}, {'name': 'Insulin Glargine', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Insulin Glargine']}]}, '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'}}}}