Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 1:38 AM
Study NCT ID:
NCT01300260
Status:
COMPLETED
Last Update Posted:
2014-10-07
First Post:
2011-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of LY2189265 on Insulin Secretion in Response to Intravenous Glucose
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555680', 'term': 'dulaglutide'}, {'id': 'D007328', 'term': 'Insulin'}, {'id': 'D061268', 'term': 'Insulin Lispro'}, {'id': 'D005947', 'term': 'Glucose'}, {'id': 'D005934', 'term': 'Glucagon'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'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'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D052336', 'term': 'Proglucagon'}]}}, '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': 'Healthy Participants: Placebo', 'description': 'Healthy participants who received at least 1 subcutaneous injection of Placebo', 'otherNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Participants: LY2189265', 'description': 'Healthy participants who received at least 1 subcutaneous injection of 1.5 milligram (mg) LY2189265', 'otherNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Participants With Type 2 Diabetes Mellitus (T2DM): Placebo', 'description': 'T2DM participants who received at least 1 subcutaneous injection of Placebo', 'otherNumAtRisk': 21, 'otherNumAffected': 9, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265', 'description': 'T2DM participants who received at least 1 subcutaneous injection of 1.5 milligram (mg) LY2189265', 'otherNumAtRisk': 21, 'otherNumAffected': 11, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Infusion site phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Insulin Concentration (Cmax) - First Phase Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants: Placebo', 'description': 'Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes).'}, {'id': 'OG001', 'title': 'Healthy Participants: LY2189265', 'description': 'Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes).'}, {'id': 'OG002', 'title': 'Participants With Type 2 Diabetes Mellitus (T2DM): Placebo', 'description': 'T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes).'}, {'id': 'OG003', 'title': 'Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265', 'description': 'T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes).'}], 'classes': [{'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000', 'lowerLimit': '154', 'upperLimit': '352'}, {'value': '689', 'groupId': 'OG001', 'lowerLimit': '455', 'upperLimit': '1041'}, {'value': '74.3', 'groupId': 'OG002', 'lowerLimit': '46.8', 'upperLimit': '118'}, {'value': '401', 'groupId': 'OG003', 'lowerLimit': '252', 'upperLimit': '637'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric least squares (LS) mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.96', 'ciLowerLimit': '2.41', 'ciUpperLimit': '3.64', 'pValueComment': 'P-value is two-sided.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric least squares (LS) means ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.40', 'ciLowerLimit': '4.09', 'ciUpperLimit': '7.13', 'pValueComment': 'P-value is two-sided.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-10 minutes after dextrose bolus on Day 3 postdose', 'description': 'On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 0 to 10 minutes (INSCmax\\[0-10\\]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.', 'unitOfMeasure': 'picomole per liter (pmol/L)', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'All participants (healthy and with type 2 diabetes mellitus \\[T2DM\\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmax(0-10) first response phase data.'}, {'type': 'PRIMARY', 'title': 'Area Under the Insulin Concentration-time Curve (AUC) - First Phase Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants: Placebo', 'description': 'Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes).'}, {'id': 'OG001', 'title': 'Healthy Participants: LY2189265', 'description': 'Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes).'}, {'id': 'OG002', 'title': 'Participants With Type 2 Diabetes Mellitus (T2DM): Placebo', 'description': 'T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes)'}, {'id': 'OG003', 'title': 'Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265', 'description': 'T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes).'}], 'classes': [{'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '34.9'}, {'value': '70.7', 'groupId': 'OG001', 'lowerLimit': '46.3', 'upperLimit': '108'}, {'value': '5.06', 'groupId': 'OG002', 'lowerLimit': '2.90', 'upperLimit': '8.83'}, {'value': '40.1', 'groupId': 'OG003', 'lowerLimit': '22.8', 'upperLimit': '70.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric least squares (LS) mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.09', 'ciLowerLimit': '2.66', 'ciUpperLimit': '3.59', 'pValueComment': 'P-value is two-sided.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric least squares (LS) mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.92', 'ciLowerLimit': '4.82', 'ciUpperLimit': '13.0', 'pValueComment': 'P-value is two-sided.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-10 minutes after dextrose bolus on Day 3 postdose', 'description': 'On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 0 to 10 minutes (INSAUC\\[0-10\\]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.', 'unitOfMeasure': 'picomole times hour per liter (pmol*h/L)', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'All participants (healthy and with type 2 diabetes mellitus \\[T2DM\\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUC(0-10) first phase response data.'}, {'type': 'PRIMARY', 'title': 'Maximum Insulin Concentration (Cmax) - Second Phase Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants: Placebo', 'description': 'Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes).'}, {'id': 'OG001', 'title': 'Healthy Participants: LY2189265', 'description': 'Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes).'}, {'id': 'OG002', 'title': 'Participants With Type 2 Diabetes Mellitus (T2DM): Placebo', 'description': 'T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes).'}, {'id': 'OG003', 'title': 'Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265', 'description': 'T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes).'}], 'classes': [{'categories': [{'measurements': [{'value': '89.2', 'groupId': 'OG000', 'lowerLimit': '64.7', 'upperLimit': '123'}, {'value': '370', 'groupId': 'OG001', 'lowerLimit': '269', 'upperLimit': '511'}, {'value': '95.9', 'groupId': 'OG002', 'lowerLimit': '66.3', 'upperLimit': '139'}, {'value': '363', 'groupId': 'OG003', 'lowerLimit': '250', 'upperLimit': '526'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric least squares (LS) mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.15', 'ciLowerLimit': '3.45', 'ciUpperLimit': '5.00', 'pValueComment': 'P-value is two-sided.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric least squares (LS) mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.78', 'ciLowerLimit': '2.99', 'ciUpperLimit': '4.78', 'pValueComment': 'P-value is two-sided.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '10-180 minutes after dextrose bolus on Day 3 postdose', 'description': 'On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 10 to 180 minutes (INSCmax\\[10-180\\]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.', 'unitOfMeasure': 'picomole per liter (pmol/L)]', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'All participants (healthy and with type 2 diabetes mellitus \\[T2DM\\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmax(10-180) second response phase data.'}, {'type': 'PRIMARY', 'title': 'Insulin Area Under the Curve (AUC) - Second Phase Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants: Placebo', 'description': 'Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes).'}, {'id': 'OG001', 'title': 'Healthy Participants: LY2189265', 'description': 'Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes).'}, {'id': 'OG002', 'title': 'Participants With Type 2 Diabetes Mellitus (T2DM): Placebo', 'description': 'T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes).'}, {'id': 'OG003', 'title': 'Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265', 'description': 'T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes).'}], 'classes': [{'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000', 'lowerLimit': '41.7', 'upperLimit': '114'}, {'value': '141', 'groupId': 'OG001', 'lowerLimit': '85.3', 'upperLimit': '232'}, {'value': '147', 'groupId': 'OG002', 'lowerLimit': '103', 'upperLimit': '209'}, {'value': '357', 'groupId': 'OG003', 'lowerLimit': '250', 'upperLimit': '511'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric least squares (LS) mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.04', 'ciLowerLimit': '1.26', 'ciUpperLimit': '3.31', 'pValueComment': 'P-value is two-sided.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric least squares (LS) mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.44', 'ciLowerLimit': '1.71', 'ciUpperLimit': '3.47', 'pValueComment': 'P-value is two-sided.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '10-180 minutes after dextrose bolus on Day 3 post dose', 'description': 'On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 10 to 180 minutes (INSAUC\\[10-180\\]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.', 'unitOfMeasure': 'picomole times hour per liter (pmol*h/L)', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'All participants (healthy and with type 2 diabetes mellitus \\[T2DM\\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUC(10-180) second response phase data.'}, {'type': 'SECONDARY', 'title': 'Insulin Maximum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants: Placebo', 'description': 'Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.'}, {'id': 'OG001', 'title': 'Healthy Participants: LY2189265', 'description': 'Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.'}, {'id': 'OG002', 'title': 'Participants With Type 2 Diabetes Mellitus (T2DM): Placebo', 'description': 'T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.'}, {'id': 'OG003', 'title': 'Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265', 'description': 'T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '996', 'groupId': 'OG000', 'lowerLimit': '716', 'upperLimit': '1386'}, {'value': '1215', 'groupId': 'OG001', 'lowerLimit': '874', 'upperLimit': '1690'}, {'value': '1088', 'groupId': 'OG002', 'lowerLimit': '827', 'upperLimit': '1431'}, {'value': '1514', 'groupId': 'OG003', 'lowerLimit': '1151', 'upperLimit': '1991'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric least squares (LS) mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '1.04', 'ciUpperLimit': '1.43', 'pValueComment': 'P-value is two-sided.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric least squares (LS) mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.39', 'ciLowerLimit': '1.27', 'ciUpperLimit': '1.53', 'pValueComment': 'P-value is two-sided.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After glucagon bolus on Day 3 postdose', 'description': 'On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. Maximum plasma insulin concentration from -2 to 20 minutes following the glucagon bolus (INSCmaxG) is presented.', 'unitOfMeasure': 'picomole per liter (pmol/L)', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'All participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSCmaxG data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Area Under the Insulin Concentration-time Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants: Placebo', 'description': 'Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered'}, {'id': 'OG001', 'title': 'Healthy Participants: LY2189265', 'description': 'Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.'}, {'id': 'OG002', 'title': 'Participants With Type 2 Diabetes Mellitus (T2DM): Placebo', 'description': 'T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.'}, {'id': 'OG003', 'title': 'Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265', 'description': 'T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.'}], 'classes': [{'categories': [{'measurements': [{'value': '239', 'groupId': 'OG000', 'lowerLimit': '167', 'upperLimit': '340'}, {'value': '341', 'groupId': 'OG001', 'lowerLimit': '239', 'upperLimit': '486'}, {'value': '236', 'groupId': 'OG002', 'lowerLimit': '177', 'upperLimit': '316'}, {'value': '414', 'groupId': 'OG003', 'lowerLimit': '310', 'upperLimit': '554'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric least squares (LS) mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.43', 'ciLowerLimit': '1.14', 'ciUpperLimit': '1.80', 'pValueComment': 'P-value is two-sided.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric least squares (LS) mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.75', 'ciLowerLimit': '1.59', 'ciUpperLimit': '1.94', 'pValueComment': 'P-value is 2-sided.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'After glucagon bolus on Day 3 postdose', 'description': 'On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. Area under the plasma insulin concentration-time curve from -2 to 20 minutes following the glucagon bolus (INSAUCG) is presented.', 'unitOfMeasure': 'picomole times hour per liter (pmol*h/L)', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'All participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) who received at least 1 dose of study drug (LY2189265 or Placebo) with evaluable INSAUCG data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LY2189265 First, Then Placebo', 'description': 'Includes healthy participants or participants with T2DM. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) subcutaneous (SC) injection on Day 1 of Period 1. Placebo: Single SC injection of Placebo on Day 1 of Period 2.\n\nOn Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes \\[min\\]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hr glucose \\>10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr \\[mL/hr\\] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.\n\nThere was a washout period of ≥28 days between Periods 1 \\& 2.'}, {'id': 'FG001', 'title': 'Placebo First, Then LY2189265', 'description': 'Includes healthy participants and participants with T2DM. Placebo: Single subcutaneous (SC) injection of Placebo on Day 1 of Period 1. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) SC injection on Day 1 of Period 2.\n\nOn Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes \\[min\\]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hr glucose \\>10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr \\[mL/hr\\] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.\n\nThere was a washout period of ≥28 days between Periods 1 \\& 2.'}], 'periods': [{'title': 'Period 1 of Study: First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period of at Least 28 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2 of Study: Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Participants', 'description': 'Includes healthy participants randomized to receive 1.5 milligram (mg) LY2189265 (Dulaglutide) first or Placebo first on Day 1 of either treatment sequence.'}, {'id': 'BG001', 'title': 'Participants With Type 2 Diabetes Mellitus (T2DM)', 'description': 'Includes participants with T2DM randomized to receive 1.5 mg LY2189265 (Dulaglutide) first or Placebo first on Day 1 of either treatment sequence.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.9', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '56.3', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '54.9', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Healthy participants or participants with type 2 diabetes mellitus (T2DM) who received at least one dose of study drug (LY2189265 or Placebo).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-03', 'studyFirstSubmitDate': '2011-02-03', 'resultsFirstSubmitDate': '2014-10-03', 'studyFirstSubmitQcDate': '2011-02-18', 'lastUpdatePostDateStruct': {'date': '2014-10-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-03', 'studyFirstPostDateStruct': {'date': '2011-02-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Area Under the Insulin Concentration-time Curve (AUC)', 'timeFrame': 'After glucagon bolus on Day 3 postdose', 'description': 'On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. Area under the plasma insulin concentration-time curve from -2 to 20 minutes following the glucagon bolus (INSAUCG) is presented.'}], 'primaryOutcomes': [{'measure': 'Maximum Insulin Concentration (Cmax) - First Phase Response', 'timeFrame': '0-10 minutes after dextrose bolus on Day 3 postdose', 'description': 'On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 0 to 10 minutes (INSCmax\\[0-10\\]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.'}, {'measure': 'Area Under the Insulin Concentration-time Curve (AUC) - First Phase Response', 'timeFrame': '0-10 minutes after dextrose bolus on Day 3 postdose', 'description': 'On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 0 to 10 minutes (INSAUC\\[0-10\\]) following the first dextrose bolus (the first phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.'}, {'measure': 'Maximum Insulin Concentration (Cmax) - Second Phase Response', 'timeFrame': '10-180 minutes after dextrose bolus on Day 3 postdose', 'description': 'On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Maximum plasma insulin concentration from 10 to 180 minutes (INSCmax\\[10-180\\]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.'}, {'measure': 'Insulin Area Under the Curve (AUC) - Second Phase Response', 'timeFrame': '10-180 minutes after dextrose bolus on Day 3 post dose', 'description': 'On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. On Day 3 of each treatment period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose 50% bolus to stimulate insulin secretion. Three hours later, participants were administered a second dextrose bolus, followed by an infusion of 20% dextrose and, 15 minutes after the start of the 20% dextrose infusion, a 1-mg glucagon bolus was administered. Area under the plasma insulin concentration time curve from 10 to 180 minutes (INSAUC\\[10-180\\]) following the first dextrose bolus (the second phase response) was corrected for baseline, where baseline was the mean of the insulin concentrations obtained between -30 and 0 minutes relative to the first dextrose bolus.'}], 'secondaryOutcomes': [{'measure': 'Insulin Maximum Concentration (Cmax)', 'timeFrame': 'After glucagon bolus on Day 3 postdose', 'description': 'On Day 1 of each treatment period, all participants (healthy or with type 2 diabetes mellitus \\[T2DM\\]) received a single subcutaneous dose of either LY2189265 or placebo. Maximum plasma insulin concentration from -2 to 20 minutes following the glucagon bolus (INSCmaxG) is presented.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure the effect of LY2189265 to increase insulin levels in response to glucose intake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nAll Participants\n\n* Women must be surgically sterile (hysterectomy or bilateral oophorectomy or tubal ligation) or postmenopausal as defined by age \\>45 years without use of oral contraceptive agents for greater than 1 year and have either:\n\n * spontaneous amenorrhea greater than 12 months, or\n * spontaneous amenorrhea 6 to 12 months with documented follicle stimulating hormone (FSH) \\>25 milli international units/milliliter (mIU/mL) and serum estradiol \\<73 picomoles/liter (pmol/L) (20 picograms/milliliter \\[pg/mL\\])\n* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n* Have given written informed consent approved by Lilly and the ethical review board governing the site\n* Have serum creatinine \\<150 micromoles/liter (µmol/L) (\\<1.3 milligrams/deciliter \\[mg/dl\\] in women, \\<170 µmol/L \\[\\<1.5 mg/dL\\] in men)\n* Have normal hemoglobin result, as determined by the investigator\n\nHealthy Participants\n\n* Overtly healthy men and women as determined by medical history, normal lab results and physical examination.\n* Body mass index (BMI) between 19 and 25 kilograms/meter squared (kg/m\\^2), inclusive.\n* Normal blood pressure and heart rate as determined by the investigator\n* Have a normal response to an oral glucose tolerance test (OGTT) (glucose \\<7.8 millimoles/liter \\[mmol/L\\] \\[\\<140 mg/dL\\] at 2 hours after 75 grams (g) oral glucose load)\n\nParticipants with type 2 diabetes mellitus (T2DM)\n\n* Participants will have a BMI between 22.0 and 40.0 kg/m\\^2\n* Have T2DM controlled with diet and exercise alone or metformin for at least 4 weeks prior to admission\n* Have a hemoglobin A1c (HbA1c) value at screening (or within 4 weeks prior to screening) of 6.0% to 9.5%\n* Diagnosed with T2DM within the past 10 years\n* Clinical laboratory test results within normal range or deemed clinically insignificant by the Investigator. Abnormalities of serum glucose, serum lipids, urinary glucose, and urinary protein consistent with T2DM are acceptable.\n* Participants who are taking stable-dose prescription medications (for example, antihypertensive agents, aspirin, lipid-lowering agents) for treatment of concurrent medical conditions are permitted to participate providing the medication is not associated with development of torsade de pointes. However, use of beta-blockers and thiazide diuretics are not permitted during this study.\n\nExclusion Criteria:\n\nAll Participants\n\n* Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication\n* Known allergies to Glucagon-Like Peptide 1 (GLP-1) related compounds\n* Have previously completed or withdrawn from this study or any other study in the last year investigating glucagon-like peptides or incretin mimetics including exenatide (Byetta®)\n* Regular use of known drugs of abuse and/or positive findings on urinary drug screening, other than findings consistent with medication prescribed by the participant's physician(s)\n* History or presence of cardiovascular, respiratory, renal, endocrine (except T2DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data\n* Have a history or presence of gastrointestinal disorder\n* Poorly controlled hypertension (systolic greater than 160 millimeters of mercury \\[mmHg\\], diastolic greater than 95 mmHg) and/or evidence of labile blood pressure including symptomatic postural hypotension. Use of beta-blockers or thiazide diuretics is not permitted during the study\n* Have a clinically significant history of cardiac disease or presence of active cardiac disease within 1 year of the screening period\n* Evidence of hepatitis C and/or positive hepatitis C antibody\n* Evidence of hepatitis B and/or positive hepatitis B surface antigen\n* Evidence of human immunodeficiency virus (HIV) and/or positive for HIV antibodies\n* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) or are unwilling to follow alcohol restrictions (1 unit = 12 ounces \\[oz\\] or 360 milliliters\\[mL\\] of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).\n* Smoke more than 10 cigarettes or equivalent in nicotine use or nicotine substitutes per day\n* Regular use of systemic corticosteroids by oral, intravenous, or intramuscular route, or potent, inhaled, or intranasal steroids known to have a high rate of systemic absorption\n* Have a history or presence of significant active neuropsychiatric disease\n* Blood donation of more than 500 mL in the last 3 months or any blood donation within the last month\n* Any other condition, which in the opinion of the investigator would preclude participation in the study\n* An abnormality in the 12-lead electrocardiogram (ECG) that in the opinion of the investigator increases the risk of participating in the study.\n* Any clinically significant abnormal hematology, clinical chemistry, or urinary result(s) as determined by the investigator\n* Evidence of significant active uncontrolled endocrine or autoimmune abnormalities (for example thyroid disease, or pernicious anemia) as judged by the screening physician\n\nHealthy Participants\n\n* Intended use of over-the-counter or prescription medication 7 and 14 days, respectively, prior to dosing.\n\nParticipants with T2DM\n\n* Clinically significant peripheral vascular occlusive disease (PVOD).\n* Known severe exudative diabetic retinopathy\n* Known significant autonomic neuropathy as evidenced by urinary retention, diabetic diarrhea, or gastroparesis\n* Have experienced a ketoacidotic episode (pH less than 7.3) requiring hospitalization in the last 6 months\n* Outpatient use of insulin for control of diabetes within the past 2 years\n* Use of antidiabetic agents other than metformin in the 4 weeks prior to study entry or use of thiazolidinediones within 12 weeks of study entry"}, 'identificationModule': {'nctId': 'NCT01300260', 'briefTitle': 'Effect of LY2189265 on Insulin Secretion in Response to Intravenous Glucose', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'The Effect of LY2189265 on Insulin Secretion in Response to Intravenous Glucose Infusion', 'orgStudyIdInfo': {'id': '11371'}, 'secondaryIdInfos': [{'id': 'H9X-MC-GBCI', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY2189265 then Placebo', 'description': 'LY2189265 (Dulaglutide) then Placebo: A single 1.5 milligram (mg) subcutaneous (SC) injection of LY2189265 on Day 1 in Period 1, followed by a single SC injection of Placebo on Day 1 in Period 2.\n\nOn Day 3 of each period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose bolus (0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus of 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.\n\nThere was a washout period of at least 28 days between Periods 1 and 2.', 'interventionNames': ['Biological: LY2189265', 'Drug: Placebo', 'Drug: Insulin', 'Drug: Glucose', 'Drug: Glucagon']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo then LY2189265', 'description': 'Placebo then LY2189265 (Dulaglutide): A single subcutaneous injection of Placebo on Day 1 in Period 1, followed by a single 1.5 milligrams (mg) subcutaneous injection of LY2189265 on Day 1 in Period 2.\n\nOn Day 3 of each period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose bolus (0.3 gram/kilogram \\[g/kg\\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus of 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \\[mmol/L\\] or 15 g of 50% dextrose for participants with 3-hour glucose \\>10 mmol/L), followed by a 20% dextrose at the set infusion rate of 600 milliliter/hour \\[mL/h\\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.\n\nThere was a washout period of at least 28 days between Periods 1 and 2.', 'interventionNames': ['Biological: LY2189265', 'Drug: Placebo', 'Drug: Insulin', 'Drug: Glucose', 'Drug: Glucagon']}], 'interventions': [{'name': 'LY2189265', 'type': 'BIOLOGICAL', 'otherNames': ['Dulaglutide'], 'description': 'Administered subcutaneously', 'armGroupLabels': ['LY2189265 then Placebo', 'Placebo then LY2189265']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered subcutaneously', 'armGroupLabels': ['LY2189265 then Placebo', 'Placebo then LY2189265']}, {'name': 'Insulin', 'type': 'DRUG', 'otherNames': ['Lispro'], 'description': 'Administered intravenously', 'armGroupLabels': ['LY2189265 then Placebo', 'Placebo then LY2189265']}, {'name': 'Glucose', 'type': 'DRUG', 'otherNames': ['Dextrose'], 'description': 'Administered intravenously', 'armGroupLabels': ['LY2189265 then Placebo', 'Placebo then LY2189265']}, {'name': 'Glucagon', 'type': 'DRUG', 'otherNames': ['Glucagon hydrochloride'], 'description': 'Administered intravenously', 'armGroupLabels': ['LY2189265 then Placebo', 'Placebo then LY2189265']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-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'}}}}