Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-05 @ 6:34 PM
Study NCT ID:
NCT01894568
Status:
COMPLETED
Last Update Posted:
2019-03-15
First Post:
2013-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing Insulin Peglispro With Insulin Glargine as Basal Insulin Treatment
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': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'C030516', 'term': 'meglitinide'}, {'id': 'D018819', 'term': 'Dipeptidyl Peptidase 4'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D000077205', 'term': 'Pioglitazone'}], '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': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D004152', 'term': 'Dipeptidyl-Peptidases and Tripeptidyl-Peptidases'}, {'id': 'D020689', 'term': 'Exopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D000945', 'term': 'Antigens, Differentiation, T-Lymphocyte'}, {'id': 'D000943', 'term': 'Antigens, Differentiation'}, {'id': 'D000954', 'term': 'Antigens, Surface'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D015415', 'term': 'Biomarkers'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.', 'otherNumAtRisk': 192, 'otherNumAffected': 61, 'seriousNumAtRisk': 192, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.', 'otherNumAtRisk': 196, 'otherNumAffected': 42, 'seriousNumAtRisk': 196, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 46, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 40, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haemorrhagic diathesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intervertebral disc displacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fracture treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Glaucoma surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Suprapubic prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.61', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-1.36', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '-0.07', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '0.4% is the margin of Non-inferiority'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': "Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis adjusting for treatment, stratification factors (region, sulfonylureas/meglitinide use, baseline Low-Density Lipoprotein \\[LDL-C\\], visit, treatment-by-visit interaction, and baseline HbA1c as fixed effects and participants as the random effect. P-value is from MMRM with terms for treatment, visit, treatment-by-visit interaction, stratification, and baseline HbA1C.", 'unitOfMeasure': 'percent of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and had evaluable HbA1c data'}, {'type': 'SECONDARY', 'title': '30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'title': 'Total HE', 'categories': [{'measurements': [{'value': '1.28', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Nocturnal HE', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 26', 'description': 'Hypoglycemia Events (HE) occurs when blood glucose level ≤ 70 milligram per deciliter (mg/dL) (\\<3.9 micromoles per liter \\[mmol/L\\]). Nocturnal HE includes any total HE that occurred between bedtime and waking. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models with treatment, baseline sulfonylurea/meglitinide use, baseline total hypoglycemia event rate, log (exposure/30 days) as the offset in the model. Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.', 'unitOfMeasure': 'Number of events per participant per 30d', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and had evaluable HE data.'}, {'type': 'SECONDARY', 'title': 'Fasting Serum Glucose (FSG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '164.31', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '166.61', 'spread': '2.76', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '103.85', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '110.32', 'spread': '1.90', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 0 and 26', 'description': 'LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and sulfonylurea \\[SU\\]/meglitinide use), visit, and treatment-by-visit interaction.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and had evaluable FSG data.'}, {'type': 'SECONDARY', 'title': 'Fasting Blood Glucose (FBG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '159.53', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '161.19', 'spread': '2.48', 'groupId': 'OG001'}]}]}, {'title': 'Week 26', 'categories': [{'measurements': [{'value': '108.39', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '108.22', 'spread': '1.55', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 0 and 26', 'description': 'LS Means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and had evaluable FBG data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.06', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '1.57', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'LS Means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction.', 'unitOfMeasure': 'Kilogram (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and had evaluable body weight data.'}, {'type': 'SECONDARY', 'title': '9-Point Self-Monitored Blood Glucose (SMBG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'title': 'Morning Pre-meal Wk0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '160.19', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '162.83', 'spread': '2.62', 'groupId': 'OG001'}]}]}, {'title': 'Morning Pre-meal Wk26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '108.24', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '108.71', 'spread': '1.65', 'groupId': 'OG001'}]}]}, {'title': 'Morning Post-meal Wk0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '237.19', 'spread': '4.26', 'groupId': 'OG000'}, {'value': '233.37', 'spread': '4.21', 'groupId': 'OG001'}]}]}, {'title': 'Morning Post-meal Wk26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '176.97', 'spread': '3.31', 'groupId': 'OG000'}, {'value': '176.93', 'spread': '3.23', 'groupId': 'OG001'}]}]}, {'title': 'Mid-day Pre-meal Wk0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '169.24', 'spread': '3.80', 'groupId': 'OG000'}, {'value': '166.68', 'spread': '3.76', 'groupId': 'OG001'}]}]}, {'title': 'Mid-day Pre-meal Wk26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122.01', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '122.85', 'spread': '2.50', 'groupId': 'OG001'}]}]}, {'title': 'Mid-day Post-meal Wk0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '224.22', 'spread': '4.23', 'groupId': 'OG000'}, {'value': '226.11', 'spread': '4.21', 'groupId': 'OG001'}]}]}, {'title': 'Mid-day Post-meal Wk26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '182.32', 'spread': '3.26', 'groupId': 'OG000'}, {'value': '183.88', 'spread': '3.18', 'groupId': 'OG001'}]}]}, {'title': 'Evening Pre-meal Wk0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '176.49', 'spread': '3.80', 'groupId': 'OG000'}, {'value': '172.83', 'spread': '3.75', 'groupId': 'OG001'}]}]}, {'title': 'Evening Pre-meal Wk26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '131.65', 'spread': '3.08', 'groupId': 'OG000'}, {'value': '135.55', 'spread': '2.99', 'groupId': 'OG001'}]}]}, {'title': 'Evening Post-meal Wk0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '219.45', 'spread': '4.20', 'groupId': 'OG000'}, {'value': '219.54', 'spread': '4.16', 'groupId': 'OG001'}]}]}, {'title': 'Evening Post-meal Wk26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '176.23', 'spread': '3.37', 'groupId': 'OG000'}, {'value': '182.80', 'spread': '3.26', 'groupId': 'OG001'}]}]}, {'title': 'Bed Time Wk0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '198.64', 'spread': '3.90', 'groupId': 'OG000'}, {'value': '197.68', 'spread': '3.83', 'groupId': 'OG001'}]}]}, {'title': 'Bed Time Wk26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '153.41', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '161.44', 'spread': '2.87', 'groupId': 'OG001'}]}]}, {'title': '0300 Hours (Hrs) Wk0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '158.82', 'spread': '3.23', 'groupId': 'OG000'}, {'value': '162.13', 'spread': '3.20', 'groupId': 'OG001'}]}]}, {'title': '0300 Hrs Wk26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115.18', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '114.77', 'spread': '2.27', 'groupId': 'OG001'}]}]}, {'title': 'Pre-morning Meal Next Day Wk0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '156.28', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '159.96', 'spread': '2.55', 'groupId': 'OG001'}]}]}, {'title': 'Pre-morning Meal Next Day Wk26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '108.42', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '105.18', 'spread': '1.71', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0 and Week 26', 'description': 'LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction. The 9-point SMBG are measured at: Pre-morning meal, 2 hours(hr) post morning meal, pre-midday meal, 2 hr post midday meal, pre-evening meal, 2 hr post pre-evening meal, bedtime, 0300 hr, and pre-morning meal next day, and should be performed on 2 non-consecutive days.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and had evaluable SMBG data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HbA1c ≤6.5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000'}, {'value': '22.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'Percentage of participants with HbA1c ≤6.5% at Week 26 were made using a logistic regression model for endpoint used last observation carried forward (LOCF) method including treatment, baseline HbA1c value.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and had evaluable HbA1c data.'}, {'type': 'SECONDARY', 'title': 'Insulin Dose Per Kilogram (kg) of Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.01', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide), visit, and treatment-by-visit interaction.', 'unitOfMeasure': 'units per kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and had evaluable insulin dose and body weight data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Steady-State of Basal Insulin Dose at 26 Weeks (Time to Steady State for Basal Insulin [Stable Maximum Dose])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000'}, {'value': '97.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and had evaluable insulin dose data.'}, {'type': 'SECONDARY', 'title': 'Concentration of Triglycerides, Total Cholesterol, Low-Density Lipoprotein (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'title': 'Cholesterol Wk26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '175.76', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '177.90', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'HDL Wk26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.64', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '52.99', 'spread': '0.48', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides Wk26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '132.43', 'spread': '4.71', 'groupId': 'OG000'}, {'value': '122.83', 'spread': '4.65', 'groupId': 'OG001'}]}]}, {'title': 'LDL Wk26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.95', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '101.07', 'spread': '1.46', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit, and treatment-by-visit interaction.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and had evaluable laboratory data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Detectable Anti-Insulin Peglispro Antibodies at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '32.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'For participants with detectable anti-insulin peglispro antibody level, the percentage of participants with positive cross-react with endogenous insulin was summarized.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and had evaluable antibody data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of European Quality of Life-5 Dimensions - 3 Levels (EuroQoL-5D-3L ) Index Score and Visual Analog Scale (VAS) Health State Score at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'title': 'Change from Baseline to Endpoint EQ-5D-3L Score', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline VAS Health State Score', 'categories': [{'measurements': [{'value': '2.29', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '3.66', 'spread': '0.90', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'The EuroQoL-5D-3L questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-level scale of 1 to 3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores ranged from -0.11 to 1.0 where a score of 1.0 indicates perfect health. Overall health state score was self-reported using a VAS marked on a scale of 0 to 100 (0 indicates worst imaginable health state and 100 indicates best imaginable health state. LS means were calculated using analysis of covariance (ANCOVA) for actual measures and changes from baseline at endpoint using LOCF method: adjusting for treatment, stratification factors (region, HbA1c and SU/meglitin.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and had evaluable EQ-5D data. Missing endpoints were imputed with last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Insulin Treatment Satisfaction Questionnaire (ITSQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'title': 'ITSQ Wk4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.13', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '75.94', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'ITSQ Wk26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.73', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '78.29', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 4 and 26', 'description': 'The Insulin Treatment Satisfaction Questionnaire is a validated instrument containing 22 items that assessed treatment satisfaction for participants with diabetes on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means was achieved using a MMRM model for post-baseline measures with stratification factors (country, HbA1c, and SU/meglitinide use) treatment, visit, treatment-by-visit as fixed effects. ITSQ was assessed at Week 4 (baseline) and Week 26.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and have evaluable ITSQ data. Missing endpoints were imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.51', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '0.68', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'LBSS is a validated, participant-reported 33-item questionnaire with items rated on a 5-point Likert scale, where 0 = never and 5 - always. The LBSS measures behaviors to avoid hypoglycemia and its negative consequences (15 items) and worries about hypoglycemia and its negative consequences (18 items). Total score is the sum of all items (range 0 to 132). Higher total scores reflect greater fear of hypoglycemia. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate. LBSS was assessed during screening visit (baseline) and again at Week 26.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and had evaluable LBSS data.'}, {'type': 'SECONDARY', 'title': 'Intra-Participant Variability of the Fasting Blood Glucose (FBG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.97', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '15.12', 'spread': '0.75', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Intra-participant variability of Fasting Blood Glucose (FBG), which was measured by Self Monitored Blood Glucose (SMBG), was assessed by the standard deviation of the FBG measurement at the Week 26 visit. LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C \\[\\< 100 mg/dL and ≥ 100 mg/dL\\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and had at least 1 dose of study drug and had evaluable FBG data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 12 Weeks in Hemoglobin A1c (HbA1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.43', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-1.22', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months.LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C \\[\\< 100 mg/dL and ≥ 100 mg/dL\\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.", 'unitOfMeasure': 'percent of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and had evaluable HbA1c data.'}, {'type': 'SECONDARY', 'title': 'Percent Hemoglobin A1c at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.92', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '7.17', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': "HbA1c is a test that measures a participant's average blood glucose level over the past 2 to 3 months. LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C \\[\\< 100 mg/dL and ≥ 100 mg/dL\\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.", 'unitOfMeasure': 'percent of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and had evaluable HbA1c data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Total and Nocturnal Hypoglycemic Events (HE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'classes': [{'title': 'Nocturnal Hypoglycemia BG 70mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000'}, {'value': '29.6', 'groupId': 'OG001'}]}]}, {'title': 'Total Hypoglycemia BG 70mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.1', 'groupId': 'OG000'}, {'value': '76.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 26', 'description': 'Percentage of participants with hypoglycemic events (total or nocturnal) to Week 26 based on BG Threshold 70mg/dL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized and received at least 1 dose of study drug and had evaluable HE data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks.'}, {'id': 'FG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '196'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '196'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '182'}, {'groupId': 'FG001', 'numSubjects': '186'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol required discontinuation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered SC once daily for 26 weeks.'}, {'id': 'BG001', 'title': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}]}], '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'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '388', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Hemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.59', 'spread': '1.09', 'groupId': 'BG000'}, {'value': '8.48', 'spread': '0.85', 'groupId': 'BG001'}, {'value': '8.53', 'spread': '0.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Serum Glucose (FSG)', 'classes': [{'categories': [{'measurements': [{'value': '165.11', 'spread': '41.25', 'groupId': 'BG000'}, {'value': '166.64', 'spread': '36.81', 'groupId': 'BG001'}, {'value': '165.88', 'spread': '39.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'milligram per deciliter (mg/dL)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'dispFirstSubmitDate': '2015-09-03', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2013-07-03', 'dispFirstSubmitQcDate': '2015-09-03', 'resultsFirstSubmitDate': '2018-03-17', 'studyFirstSubmitQcDate': '2013-07-03', 'dispFirstPostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-13', 'studyFirstPostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline, Week 26', 'description': "Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis adjusting for treatment, stratification factors (region, sulfonylureas/meglitinide use, baseline Low-Density Lipoprotein \\[LDL-C\\], visit, treatment-by-visit interaction, and baseline HbA1c as fixed effects and participants as the random effect. P-value is from MMRM with terms for treatment, visit, treatment-by-visit interaction, stratification, and baseline HbA1C."}], 'secondaryOutcomes': [{'measure': '30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events', 'timeFrame': 'Baseline to Week 26', 'description': 'Hypoglycemia Events (HE) occurs when blood glucose level ≤ 70 milligram per deciliter (mg/dL) (\\<3.9 micromoles per liter \\[mmol/L\\]). Nocturnal HE includes any total HE that occurred between bedtime and waking. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models with treatment, baseline sulfonylurea/meglitinide use, baseline total hypoglycemia event rate, log (exposure/30 days) as the offset in the model. Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.'}, {'measure': 'Fasting Serum Glucose (FSG)', 'timeFrame': 'Weeks 0 and 26', 'description': 'LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and sulfonylurea \\[SU\\]/meglitinide use), visit, and treatment-by-visit interaction.'}, {'measure': 'Fasting Blood Glucose (FBG)', 'timeFrame': 'Weeks 0 and 26', 'description': 'LS Means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction.'}, {'measure': 'Change From Baseline to Week 26 in Body Weight', 'timeFrame': 'Baseline, Week 26', 'description': 'LS Means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction.'}, {'measure': '9-Point Self-Monitored Blood Glucose (SMBG)', 'timeFrame': 'Week 0 and Week 26', 'description': 'LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction. The 9-point SMBG are measured at: Pre-morning meal, 2 hours(hr) post morning meal, pre-midday meal, 2 hr post midday meal, pre-evening meal, 2 hr post pre-evening meal, bedtime, 0300 hr, and pre-morning meal next day, and should be performed on 2 non-consecutive days.'}, {'measure': 'Percentage of Participants With HbA1c ≤6.5%', 'timeFrame': 'Week 26', 'description': 'Percentage of participants with HbA1c ≤6.5% at Week 26 were made using a logistic regression model for endpoint used last observation carried forward (LOCF) method including treatment, baseline HbA1c value.'}, {'measure': 'Insulin Dose Per Kilogram (kg) of Body Weight', 'timeFrame': 'Week 26', 'description': 'LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide), visit, and treatment-by-visit interaction.'}, {'measure': 'Percentage of Participants Achieving Steady-State of Basal Insulin Dose at 26 Weeks (Time to Steady State for Basal Insulin [Stable Maximum Dose])', 'timeFrame': 'Week 26'}, {'measure': 'Concentration of Triglycerides, Total Cholesterol, Low-Density Lipoprotein (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C) at Week 26', 'timeFrame': 'Week 26', 'description': 'LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit, and treatment-by-visit interaction.'}, {'measure': 'Percentage of Participants With Detectable Anti-Insulin Peglispro Antibodies at Week 26', 'timeFrame': 'Week 26', 'description': 'For participants with detectable anti-insulin peglispro antibody level, the percentage of participants with positive cross-react with endogenous insulin was summarized.'}, {'measure': 'Change From Baseline of European Quality of Life-5 Dimensions - 3 Levels (EuroQoL-5D-3L ) Index Score and Visual Analog Scale (VAS) Health State Score at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'The EuroQoL-5D-3L questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-level scale of 1 to 3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores ranged from -0.11 to 1.0 where a score of 1.0 indicates perfect health. Overall health state score was self-reported using a VAS marked on a scale of 0 to 100 (0 indicates worst imaginable health state and 100 indicates best imaginable health state. LS means were calculated using analysis of covariance (ANCOVA) for actual measures and changes from baseline at endpoint using LOCF method: adjusting for treatment, stratification factors (region, HbA1c and SU/meglitin.'}, {'measure': 'Insulin Treatment Satisfaction Questionnaire (ITSQ) Score', 'timeFrame': 'Week 4 and 26', 'description': 'The Insulin Treatment Satisfaction Questionnaire is a validated instrument containing 22 items that assessed treatment satisfaction for participants with diabetes on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means was achieved using a MMRM model for post-baseline measures with stratification factors (country, HbA1c, and SU/meglitinide use) treatment, visit, treatment-by-visit as fixed effects. ITSQ was assessed at Week 4 (baseline) and Week 26.'}, {'measure': 'Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores', 'timeFrame': 'Baseline, Week 26', 'description': 'LBSS is a validated, participant-reported 33-item questionnaire with items rated on a 5-point Likert scale, where 0 = never and 5 - always. The LBSS measures behaviors to avoid hypoglycemia and its negative consequences (15 items) and worries about hypoglycemia and its negative consequences (18 items). Total score is the sum of all items (range 0 to 132). Higher total scores reflect greater fear of hypoglycemia. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate. LBSS was assessed during screening visit (baseline) and again at Week 26.'}, {'measure': 'Intra-Participant Variability of the Fasting Blood Glucose (FBG)', 'timeFrame': 'Week 26', 'description': 'Intra-participant variability of Fasting Blood Glucose (FBG), which was measured by Self Monitored Blood Glucose (SMBG), was assessed by the standard deviation of the FBG measurement at the Week 26 visit. LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C \\[\\< 100 mg/dL and ≥ 100 mg/dL\\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.'}, {'measure': 'Change From Baseline to 12 Weeks in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline, Week 12', 'description': "Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months.LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C \\[\\< 100 mg/dL and ≥ 100 mg/dL\\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects."}, {'measure': 'Percent Hemoglobin A1c at Week 26', 'timeFrame': 'Week 26', 'description': "HbA1c is a test that measures a participant's average blood glucose level over the past 2 to 3 months. LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C \\[\\< 100 mg/dL and ≥ 100 mg/dL\\], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects."}, {'measure': 'Percentage of Participants With Total and Nocturnal Hypoglycemic Events (HE)', 'timeFrame': 'Baseline to Week 26', 'description': 'Percentage of participants with hypoglycemic events (total or nocturnal) to Week 26 based on BG Threshold 70mg/dL.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare insulin peglispro (LY2605541) to insulin glargine in Asian insulin naïve participants who have been treated with oral anti hyperglycemia medications. Participants will receive 26 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have Type 2 Diabetes Mellitus (T2DM) for at least 1 year not treated with insulin\n* Have been receiving at least two oral antihyperglycemic medications (OAMs) for at least 3 months prior to screening\n* Have Hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, according to central laboratory at screening\n* Body mass index (BMI) ≤35.0 kilogram per square meter (kg/m\\^2)\n* Inject insulin with a pre-filled insulin pen and perform Self-Monitored Blood Glucose (SMBG)\n* Record keeping as required by this protocol\n* Women of childbearing potential are not breastfeeding, have a negative pregnancy test at screening, do not plan to become pregnant during the study, have practiced reliable birth control during the study and 2 weeks following the last dose of investigational product\n\nExclusion Criteria:\n\n* Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short term treatment of acute conditions\n* Have been treated with rosiglitazone, pramlintide, glucagon-like peptide-1 (GLP-1) receptor agonist within 3 months prior to screening\n* Are using or have used any of the following lipid-lowering medications: niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening\n* Local OAM restrictions: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations\n* Are taking, or have taken within 3 months before screening, prescription or over-the-counter medications to promote weight loss\n* Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma within 6 months prior to screening\n* Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the past 6 months\n* Have cardiac disease with functional status that is New York Heart Association Class III or IV\n* Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine ≥2.0 milligram per deciliter (mg/dL) (177 micromole per liter \\[μmol/L\\]). Participants taking metformin should not exceed the creatinine level specified in the local label\n* Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease \\[NAFLD\\]), acute or any chronic hepatitis, non alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements\n* Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c\n* Have active or untreated cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator\n* Have known hypersensitivity or allergy to any of LY2605541 and insulin glargine or their excipients\n* Have pre proliferative and proliferative retinopathy, maculopathy requiring treatment or not clinically stable in the last 6 months, or participants with active changes in subjective eye symptoms as determined by the investigator if an eye exam has not been performed in the last 6 months\n* Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening\n* Have fasting triglycerides greater than 400 mg/dL (4.5 mmol/L) at screening as determined by the central laboratory\n* Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion"}, 'identificationModule': {'nctId': 'NCT01894568', 'briefTitle': 'A Study Comparing Insulin Peglispro With Insulin Glargine as Basal Insulin Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Open Label, Randomized, Parallel, 26 Week Treatment Study Comparing LY2605541 With Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti Hyperglycemia Medications in Asian Insulin Naïve Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '13422'}, 'secondaryIdInfos': [{'id': 'I2R-JE-BIAQ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin Peglispro', 'description': 'Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks in combination with Oral Antihyperglycemic Medications (OAMs).', 'interventionNames': ['Drug: Insulin Peglispro', 'Drug: Oral Antihyperglycemic Medications (OAMs)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Glargine', 'description': 'Insulin Glargine administered SC once daily for 26 weeks in combination with OAMs.', 'interventionNames': ['Drug: Insulin Glargine', 'Drug: Oral Antihyperglycemic Medications (OAMs)']}], 'interventions': [{'name': 'Insulin Peglispro', 'type': 'DRUG', 'otherNames': ['LY2605541'], 'description': 'Administered SC using a prefilled pen.', 'armGroupLabels': ['Insulin Peglispro']}, {'name': 'Insulin Glargine', 'type': 'DRUG', 'description': 'Administered SC using a prefilled pen', 'armGroupLabels': ['Insulin Glargine']}, {'name': 'Oral Antihyperglycemic Medications (OAMs)', 'type': 'DRUG', 'otherNames': ['Sulfonylureas', 'Meglitinides', 'Dipeptidyl Peptidase-4 (DPP-IV) Inhibitors', 'Biguanides', 'α-Glucosidase Inhibitors', 'Pioglitazone'], 'description': 'Administered orally', 'armGroupLabels': ['Insulin Glargine', 'Insulin Peglispro']}]}, 'contactsLocationsModule': {'locations': [{'zip': '455-8530', 'city': 'Aichi', 'country': 'Japan', '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': 32.51879, 'lon': 130.62158}}, {'zip': '277-0825', 'city': 'Chiba', 'country': 'Japan', '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': 35.6, 'lon': 140.11667}}, {'zip': '807-0857', 'city': 'Fukuoka', 'country': 'Japan', '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': 33.6, 'lon': 130.41667}}, {'zip': '060-0062', 'city': 'Hokkaido', 'country': 'Japan', '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.'}, {'zip': '662-0971', 'city': 'Hyōgo', 'country': 'Japan', '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': 43.36667, 'lon': 144.43333}}, {'zip': '311-0113', 'city': 'Ibaraki', 'country': 'Japan', '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': 34.81641, 'lon': 135.56828}}, {'zip': '765-0071', 'city': 'Kagawa', 'country': 'Japan', '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': 34.06667, 'lon': 131.03333}}, {'zip': '247-0056', 'city': 'Kanagawa', 'country': 'Japan', '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': 37.58333, 'lon': 139.91667}}, {'zip': '862-0976', 'city': 'Kumamoto', 'country': 'Japan', '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': 32.80589, 'lon': 130.69181}}, {'zip': '6150035', 'city': 'Kyoto', 'country': 'Japan', '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': 35.02107, 'lon': 135.75385}}, {'zip': '980-0021', 'city': 'Miyagi', 'country': 'Japan', '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': 26.62566, 'lon': 128.18236}}, {'zip': '880-0034', 'city': 'Miyazaki', 'country': 'Japan', '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': 31.91667, 'lon': 131.41667}}, {'zip': '399-0006', 'city': 'Nagano', 'country': 'Japan', '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': 36.65, 'lon': 138.18333}}, {'zip': '569-1096', 'city': 'Osaka', 'country': 'Japan', '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': 34.69379, 'lon': 135.50107}}, {'zip': '8700039', 'city': 'Ōita', 'country': 'Japan', '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': 33.23333, 'lon': 131.6}}, {'zip': '323-0022', 'city': 'Tochigi', 'country': 'Japan', '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': 36.38333, 'lon': 139.73333}}, {'zip': '143-8541', 'city': 'Tokyo', 'country': 'Japan', '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': 35.6895, 'lon': 139.69171}}, {'zip': '751-0815', 'city': 'Yamaguchi', 'country': 'Japan', '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': 34.18333, 'lon': 131.46667}}, {'zip': '700-712', 'city': 'Daegu', 'country': 'South Korea', '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': 35.87028, 'lon': 128.59111}}, {'zip': '405-760', 'city': 'Incheon', 'country': 'South Korea', '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': 37.45646, 'lon': 126.70515}}, {'zip': '602-739', 'city': 'Pusan', 'country': 'South Korea', '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': 36.3809, 'lon': 128.3681}}, {'zip': '158-710', 'city': 'Seoul', 'country': 'South Korea', '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': 37.566, 'lon': 126.9784}}, {'zip': '682-714', 'city': 'Ulsan', 'country': 'South Korea', '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': 35.53722, 'lon': 129.31667}}, {'zip': '220-701', 'city': 'Wŏnju', 'country': 'South Korea', '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': 37.35139, 'lon': 127.94528}}, {'zip': '23148', 'city': 'Sindian City', 'country': 'Taiwan', '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': 24.94062, 'lon': 121.53111}}, {'zip': '404', 'city': 'Taichung', 'country': 'Taiwan', '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': 24.1469, 'lon': 120.6839}}, {'zip': '433', 'city': 'Taichung County', 'country': 'Taiwan', '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.'}, {'zip': '70403', 'city': 'Tainan', 'country': 'Taiwan', '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': 22.99083, 'lon': 120.21333}}, {'zip': '220', 'city': 'Taipei', 'country': 'Taiwan', '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': 25.05306, 'lon': 121.52639}}, {'zip': '71004', 'city': 'Yongkang District', 'country': 'Taiwan', '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': 23.02444, 'lon': 120.25556}}, {'zip': '235', 'city': 'Zhonghe', 'country': 'Taiwan', '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': 24.99298, 'lon': 121.49385}}], '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'}}}}