Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-01-17 @ 3:45 AM
Study NCT ID:
NCT02197520
Status:
COMPLETED
Last Update Posted:
2018-11-01
First Post:
2014-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study To Compare the Effects of Insulin Peglispro and Glargine on Insulin Sensitivity and Meal Time Insulin Requirements in Type 2 Diabetics
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': 'C000621851', 'term': 'basal insulin peglispro'}, {'id': 'C587357', 'term': 'LY2605541'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D061268', 'term': 'Insulin Lispro'}], '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'}, {'id': 'D061266', 'term': 'Insulin, Short-Acting'}]}}, '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': 'Insulin Peglispro', 'description': 'Insulin peglispro, a once daily SC', 'otherNumAtRisk': 24, 'otherNumAffected': 14, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine, a once daily SC', 'otherNumAtRisk': 23, 'otherNumAffected': 10, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Catheter site related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin peglispro, a once daily SC'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine, a once daily SC'}], 'classes': [{'title': 'High Dose Insulin', 'categories': [{'measurements': [{'value': '59.09', 'spread': '10.48', 'groupId': 'OG000'}, {'value': '55.52', 'spread': '16.50', 'groupId': 'OG001'}]}]}, {'title': 'Low Dose Insulin', 'categories': [{'measurements': [{'value': '17.22', 'spread': '6.24', 'groupId': 'OG000'}, {'value': '19.67', 'spread': '7.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 33, last 30 minutes (final step) of euglycemic 2-step hyperinsulinemic clamp', 'description': 'During the euglycemic 2-step hyperinsulinemic clamp, both low and high insulin was infused sequentially during the same procedure. The 2-step clamp procedure allowed insulin sensitivity to be measured in participants and uses a lower dose of insulin of which the effect is largely on the liver and a high dose of insulin at which the effect has reached 100% on liver and effects are largely on glucose uptake in peripheral tissues. Measurements for average glucose infusion rate are collected for both steps (low and high) of the clamp procedure.', 'unitOfMeasure': 'milligram*hour per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug and had evaluable PD parameters.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin peglispro, once daily SC'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine, a once daily SC'}], 'classes': [{'title': '10% Insulin Lispro Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '437.78', 'spread': '147.47', 'groupId': 'OG000'}, {'value': '398.26', 'spread': '159.89', 'groupId': 'OG001'}]}]}, {'title': '20% Insulin Lispro Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '334.23', 'spread': '165.96', 'groupId': 'OG000'}, {'value': '343.54', 'spread': '182.13', 'groupId': 'OG001'}]}]}, {'title': '30% Insulin Lispro Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '244.68', 'spread': '136.01', 'groupId': 'OG000'}, {'value': '239.83', 'spread': '175.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast', 'unitOfMeasure': 'milligram*hour per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug and had evaluable PD parameters.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration Curve Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin peglispro, a once daily SC'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine, a once daily SC'}], 'classes': [{'categories': [{'measurements': [{'value': '839', 'spread': '47', 'groupId': 'OG000'}, {'value': '835', 'spread': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast', 'unitOfMeasure': 'picomol*hour per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug and had evaluable PK parameters.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Acetaminophen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin peglispro, a once daily SC'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine, a once daily SC'}], 'classes': [{'categories': [{'measurements': [{'value': '33700', 'spread': '28', 'groupId': 'OG000'}, {'value': '35700', 'spread': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 29:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast', 'unitOfMeasure': 'nanograms*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin peglispro, a once daily SC'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine, a once daily SC'}], 'classes': [{'title': 'Hunger: Waking', 'categories': [{'measurements': [{'value': '25.7', 'spread': '23.2', 'groupId': 'OG000'}, {'value': '38.6', 'spread': '31.3', 'groupId': 'OG001'}]}]}, {'title': 'Food amount: Waking', 'categories': [{'measurements': [{'value': '30.2', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '34.4', 'spread': '25.6', 'groupId': 'OG001'}]}]}, {'title': 'Hunger: Pre-breakfast', 'categories': [{'measurements': [{'value': '41.5', 'spread': '30.1', 'groupId': 'OG000'}, {'value': '51.4', 'spread': '32.8', 'groupId': 'OG001'}]}]}, {'title': 'Food amount: Pre-breakfast', 'categories': [{'measurements': [{'value': '43.9', 'spread': '27.7', 'groupId': 'OG000'}, {'value': '51.5', 'spread': '30.2', 'groupId': 'OG001'}]}]}, {'title': 'Hunger: 1 hour Post-breakfast', 'categories': [{'measurements': [{'value': '7.8', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '16.4', 'groupId': 'OG001'}]}]}, {'title': 'Food amount: 1 hour Post-breakfast', 'categories': [{'measurements': [{'value': '8.7', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '11.6', 'groupId': 'OG001'}]}]}, {'title': 'Hunger: 2 hour Post-breakfast', 'categories': [{'measurements': [{'value': '19.7', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '19.4', 'groupId': 'OG001'}]}]}, {'title': 'Food amount: 2 hour Post-breakfast', 'categories': [{'measurements': [{'value': '20.7', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '17.4', 'groupId': 'OG001'}]}]}, {'title': 'Hunger:3 hour Post-breakfast', 'categories': [{'measurements': [{'value': '34.8', 'spread': '26.5', 'groupId': 'OG000'}, {'value': '29.2', 'spread': '20.8', 'groupId': 'OG001'}]}]}, {'title': 'Food amount: 3 hour Post-breakfast', 'categories': [{'measurements': [{'value': '35.6', 'spread': '27.3', 'groupId': 'OG000'}, {'value': '31.1', 'spread': '20.6', 'groupId': 'OG001'}]}]}, {'title': 'Hunger: 4 hour Post-breakfast', 'categories': [{'measurements': [{'value': '46.6', 'spread': '27.8', 'groupId': 'OG000'}, {'value': '48.0', 'spread': '28.3', 'groupId': 'OG001'}]}]}, {'title': 'Food amount: 4 hour Post-breakfast', 'categories': [{'measurements': [{'value': '48.2', 'spread': '27.5', 'groupId': 'OG000'}, {'value': '48.5', 'spread': '28.2', 'groupId': 'OG001'}]}]}, {'title': 'Hunger: 5 hour Post-breakfast', 'categories': [{'measurements': [{'value': '56.8', 'spread': '28.6', 'groupId': 'OG000'}, {'value': '55.5', 'spread': '34.1', 'groupId': 'OG001'}]}]}, {'title': 'Food amount: 5 hour Post-breakfast', 'categories': [{'measurements': [{'value': '57.5', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '53.4', 'spread': '34.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 29:Upon waking, pre-breakfast, 1 hour (hr), 2 hr, 3 hr, 4 hr and 5 hr post breakfast', 'description': 'VAS was scored from 0 - 100 millimeters (mm) as a perception of appetite and satiety (Flint et al. 2000), 0 being not hungry at all or nothing at all and 100 being extremely hungry and extremely large amount.\n\nThe questions are abbreviated in table from: How hungry do you feel right now? to Hunger and How much food do you think you could eat right now? to Food amount. Scores were averaged and will be presented and calculated by a sum of the scores dividing by the total by the number of scores reported for timepoints.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug and had a VAS score.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) for Insulin Lispro During Clamp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin peglispro, a once daily SC'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin peglispro, a once daily SC'}], 'timeFrame': 'Day 33 during euglycemic 2-step hyperinsulinemic clamp', 'reportingStatus': 'POSTED', 'populationDescription': 'No participant analyzed because Outcome Measure was incorrectly registered.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence AB', 'description': 'A: Insulin peglispro, administered SC for 33 days B. Insulin glargine, administered SC for 33 days'}, {'id': 'FG001', 'title': 'Sequence BA', 'description': 'B. Insulin glargine, administered SC for 33 days A: Insulin peglispro, administered SC for 33 days'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants who received Insulin peglispro, administered SC for 33 days then Insulin glargine, administered SC for 33 days or Insulin glargine, administered SC for 33 days then Insulin peglispro, administered SC for 33 days'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '9.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '24', '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': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', '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': 'United States', 'categories': [{'measurements': [{'value': '24', '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': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-29', 'studyFirstSubmitDate': '2014-07-21', 'resultsFirstSubmitDate': '2018-03-17', 'studyFirstSubmitQcDate': '2014-07-21', 'lastUpdatePostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-29', 'studyFirstPostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)', 'timeFrame': 'Day 33, last 30 minutes (final step) of euglycemic 2-step hyperinsulinemic clamp', 'description': 'During the euglycemic 2-step hyperinsulinemic clamp, both low and high insulin was infused sequentially during the same procedure. The 2-step clamp procedure allowed insulin sensitivity to be measured in participants and uses a lower dose of insulin of which the effect is largely on the liver and a high dose of insulin at which the effect has reached 100% on liver and effects are largely on glucose uptake in peripheral tissues. Measurements for average glucose infusion rate are collected for both steps (low and high) of the clamp procedure.'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro', 'timeFrame': 'Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration Curve Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro', 'timeFrame': 'Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Acetaminophen', 'timeFrame': 'Day 29:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast'}, {'measure': 'Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29', 'timeFrame': 'Day 29:Upon waking, pre-breakfast, 1 hour (hr), 2 hr, 3 hr, 4 hr and 5 hr post breakfast', 'description': 'VAS was scored from 0 - 100 millimeters (mm) as a perception of appetite and satiety (Flint et al. 2000), 0 being not hungry at all or nothing at all and 100 being extremely hungry and extremely large amount.\n\nThe questions are abbreviated in table from: How hungry do you feel right now? to Hunger and How much food do you think you could eat right now? to Food amount. Scores were averaged and will be presented and calculated by a sum of the scores dividing by the total by the number of scores reported for timepoints.'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) for Insulin Lispro During Clamp', 'timeFrame': 'Day 33 during euglycemic 2-step hyperinsulinemic clamp'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This study will look into insulin sensitivity (how the body responds to insulin) and effects of meals on type 2 diabetics comparing insulin peglispro to insulin glargine. The study has two treatment periods, each of which will last about four weeks. One drug (insulin peglispro or insulin glargine) will be administered in each period. Participants will receive both drugs during the study. Participants may remain on stable dose metformin, as prescribed by their personal physician.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable glycated hemoglobin (HbA1c) less than (\\<) 10.0 percent (%)\n* Stable dose of either 0.2 to 1.5 units per kilogram per day (U/kg/day) basal insulin or a total daily insulin dose l\\<2.0 units per kilogram (U/kg)\n* C-peptide \\<0.3 nanomole per liter (nmol/L)\n* Stable body during the last 2 months\n\nExclusion Criteria:\n\n* Corrected QT interval (QTc) prolongation greater than (\\>) 500 milliseconds (ms) or have any other abnormality in the 12 lead\n* Abnormal blood pressure\n* A history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from Type 1 Diabetes Mellitus (T1DM)), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data\n* Currently treated with oral antidiabetic drugs (OADs) (excluding metformin and dipeptidyl peptidase-4 (DPP4) inhibitors), or glucagon-like peptide-1 (GLP-1) agonists or intend to use over-the counter or prescription medication, herbal medications, or nutritional supplements that affect PG or insulin sensitivity, impact on hypoglycemic awareness or promote weight loss within 4 weeks prior to randomization\n* Fasting triglycerides (TGs) \\>400 milligrams per deciliter (mg/dL) (4.52 millimoles per liter (mmol/L))\n* Have used systemic or inhaled corticosteroids/glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) within 4 weeks prior to randomization\n* Currently receive insulin by pump or insulin degludec\n* Poorly controlled diabetes or known to have poor awareness of hypoglycemia\n* History of gastroparesis or gastrointestinal malabsorption\n* Require treatment with any drug other than insulin to treat diabetes\n* Previous history of proliferative retinopathy\n* Excessive consumers of xanthines'}, 'identificationModule': {'nctId': 'NCT02197520', 'briefTitle': 'A Study To Compare the Effects of Insulin Peglispro and Glargine on Insulin Sensitivity and Meal Time Insulin Requirements in Type 2 Diabetics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'The Effect of Treatment With Basal Insulin Peglispro or Insulin Glargine on Insulin Sensitivity and the Effect of Prandial Insulin Lispro in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '15407'}, 'secondaryIdInfos': [{'id': 'I2R-MC-BIDV', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin Peglispro (with Insulin Lispro)', 'description': 'Insulin peglispro, a once daily subcutaneous(SC) injection at bedtime for 5 weeks', 'interventionNames': ['Drug: Insulin Peglispro', 'Drug: Insulin Lispro']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Glargine (with Insulin Lispro)', 'description': 'Insulin glargine, a once daily subcutaneous(SC) injection at bedtime for 5 weeks', 'interventionNames': ['Drug: Insulin Glargine', 'Drug: Insulin Lispro']}], 'interventions': [{'name': 'Insulin Peglispro', 'type': 'DRUG', 'otherNames': ['LY2605541'], 'description': 'Administered subcutaneously (SC), (U-100 formulation)', 'armGroupLabels': ['Insulin Peglispro (with Insulin Lispro)']}, {'name': 'Insulin Glargine', 'type': 'DRUG', 'description': 'Administered subcutaneously (SC), (U-100 formulation)', 'armGroupLabels': ['Insulin Glargine (with Insulin Lispro)']}, {'name': 'Insulin Lispro', 'type': 'DRUG', 'description': 'Administered subcutaneously (SC), (U-100 formulation)', 'armGroupLabels': ['Insulin Glargine (with Insulin Lispro)', 'Insulin Peglispro (with Insulin Lispro)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Profil Institute for Clinical Research Inc', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}], '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'}}}}