Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-02-20 @ 1:33 PM
Study NCT ID:
NCT02390050
Status:
COMPLETED
Last Update Posted:
2021-06-29
First Post:
2015-03-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets in Subjects With Type 2 Diabetes Mellitus
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': 'C000705992', 'term': 'bexagliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'acollinson@theracos.com', 'phone': '(508) 630-2129', 'title': 'Albert Collinson', 'organization': 'Theracos Sub, LLC'}, 'certainAgreement': {'otherDetails': 'Investigator has no publication right.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from Week -12 (S2, Washout period) to Week 14 (V5, Follow up period)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo tablet once daily before breakfast\n\nPlacebo tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 12, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bexagliflozin 5 mg', 'description': 'Bexagliflozin tablet, 5 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 15, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Bexagliflozin 10 mg', 'description': 'Bexagliflozin tablet, 10 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 18, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Bexagliflozin 20 mg', 'description': 'Bexagliflozin tablet, 20 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 17, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Balanoposthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastroesophageal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1c After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once daily before breakfast\n\nPlacebo tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG001', 'title': 'Bexagliflozin 5 mg', 'description': 'Bexagliflozin tablet, 5 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG002', 'title': 'Bexagliflozin 10 mg', 'description': 'Bexagliflozin tablet, 10 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG003', 'title': 'Bexagliflozin 20 mg', 'description': 'Bexagliflozin tablet, 20 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.24', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '-0.44', 'spread': '0.08', 'groupId': 'OG002'}, {'value': '-0.56', 'spread': '0.08', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '-0.34', 'pValueComment': 'P-value from Type III F-test', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.68', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '-0.47', 'pValueComment': 'P-value from Type III F-test', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-1.01', 'ciUpperLimit': '-0.59', 'pValueComment': 'P-value from Type III F-test', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': 'Mixed model repeated measures (MMRM) analysis of covariance model (ANCOVA) with baseline HbA1c as a covariate will be fit to the available data, incorporating all visits at which HbA1c was measured for each subject including scheduled visits at Weeks 2, 6, and 12 as well as unscheduled visits for measurements of HbA1c. Treatment (placebo, 5 mg, 10 mg, 20 mg), study center, prior anti-diabetic treatment status, study visit and treatment-by-visit interaction will be applied as fixed effects and subject as a random effect. The least square mean (LSM) change from baseline to Week 12 was analyzed using the Mixed-Effect Model Repeated Measure (MMRM) Analysis of Covariance (ANCOVA) model using 95% Confidence Intervals (CIs) for the between-group mean changes.', 'unitOfMeasure': 'percentage of glycated hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who were randomized, took at least one dose of double-blind study medication, and had at least one post-randomization HbA1c measurement were included in the full analysis dataset (FAS). TheHbA1c change from baseline through 12 weeks, and the primary analysis is based on the available data and data obtained after rescue will be excluded and considered missing.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With HbA1c < 7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once daily before breakfast\n\nPlacebo tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG001', 'title': 'Bexagliflozin 5 mg', 'description': 'Bexagliflozin tablet, 5 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG002', 'title': 'Bexagliflozin 10 mg', 'description': 'Bexagliflozin tablet, 10 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG003', 'title': 'Bexagliflozin 20 mg', 'description': 'Bexagliflozin tablet, 20 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1308', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '0.8', 'ciUpperLimit': '5.3', 'groupDescription': 'Odds ratio of having at least 1 post-baseline HbA1c value \\<7% in the 5 mg bexagliflozin group was compared to placebo group.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\\<7%) or 0 (\\>7%).'}, {'pValue': '0.1294', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '0.8', 'ciUpperLimit': '5.1', 'groupDescription': 'Odds ratio of having at least 1 post-baseline HbA1c value \\<7% in the 10 mg bexagliflozin group was compared to placebo group.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\\<7%) or 0 (\\>7%).'}, {'pValue': '0.0015', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '1.7', 'ciUpperLimit': '10.3', 'groupDescription': 'Odds ratio of having at least 1 post-baseline HbA1c value \\<7% in the 20 mg bexagliflozin group was compared to placebo group.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\\<7%) or 0 (\\>7%).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to up to 12 weeks', 'description': 'To assess the efficacy of bexagliflozin based on the proportion of subjects who reach the American Diabetes Associate (ADA) and the Japan Diabetes Society target HbA1c of \\<7%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with at least one post-baseline HbA1c value \\<7% met this endpoint. HbA1c values obtained after start of rescue medication were excluded from this analysis. The number and percentage of subjects with at least one HbA1c value \\<7% were summarized by treatment group for the FAS.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once daily before breakfast\n\nPlacebo tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG001', 'title': 'Bexagliflozin 5 mg', 'description': 'Bexagliflozin tablet, 5 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG002', 'title': 'Bexagliflozin 10 mg', 'description': 'Bexagliflozin tablet, 10 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG003', 'title': 'Bexagliflozin 20 mg', 'description': 'Bexagliflozin tablet, 20 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '-0.76', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '-0.99', 'spread': '0.15', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '-1.42', 'spread': '0.19', 'groupId': 'OG002'}, {'value': '-1.49', 'spread': '0.19', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-1.58', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '-1.72', 'spread': '0.25', 'groupId': 'OG002'}, {'value': '-1.89', 'spread': '0.25', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.74', 'ciLowerLimit': '-1.13', 'ciUpperLimit': '-0.36', 'groupDescription': 'Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.76', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '-0.38', 'groupDescription': 'Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.99', 'ciLowerLimit': '-1.38', 'ciUpperLimit': '-0.61', 'groupDescription': 'Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.02', 'ciLowerLimit': '-1.53', 'ciUpperLimit': '-0.52', 'groupDescription': 'Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.45', 'ciLowerLimit': '-1.95', 'ciUpperLimit': '-0.94', 'groupDescription': 'Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.51', 'ciLowerLimit': '-2.01', 'ciUpperLimit': '-1.01', 'groupDescription': 'Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.44', 'ciLowerLimit': '-2.12', 'ciUpperLimit': '-0.76', 'pValueComment': 'P-value from Type III F-test', 'groupDescription': 'Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.59', 'ciLowerLimit': '-2.26', 'ciUpperLimit': '-0.91', 'pValueComment': 'P-value from Type III F-test', 'groupDescription': 'Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.75', 'ciLowerLimit': '-2.43', 'ciUpperLimit': '-1.08', 'pValueComment': 'P-value from Type III F-test', 'groupDescription': 'Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 2, Week 6 and Week 12', 'description': 'The body weight was analyzed on the full analysis set using the MMRM ANCOVA model used for the primary efficacy analysis.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subject with a value at the specified time is included'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (FPG) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once daily before breakfast\n\nPlacebo tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG001', 'title': 'Bexagliflozin 5 mg', 'description': 'Bexagliflozin tablet, 5 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG002', 'title': 'Bexagliflozin 10 mg', 'description': 'Bexagliflozin tablet, 10 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG003', 'title': 'Bexagliflozin 20 mg', 'description': 'Bexagliflozin tablet, 20 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '-0.97', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '-1.11', 'spread': '0.15', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-1.06', 'spread': '0.17', 'groupId': 'OG002'}, {'value': '-0.99', 'spread': '0.17', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-0.96', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-1.16', 'spread': '0.17', 'groupId': 'OG002'}, {'value': '-1.18', 'spread': '0.17', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '-0.06', 'groupDescription': 'Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.90', 'ciLowerLimit': '-1.31', 'ciUpperLimit': '-0.48', 'groupDescription': 'Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.04', 'ciLowerLimit': '-1.45', 'ciUpperLimit': '-0.62', 'groupDescription': 'Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.93', 'ciLowerLimit': '-1.39', 'ciUpperLimit': '-0.48', 'groupDescription': 'Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.17', 'ciLowerLimit': '-1.62', 'ciUpperLimit': '-0.72', 'groupDescription': 'Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.10', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '-0.65', 'groupDescription': 'Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.85', 'ciLowerLimit': '-1.29', 'ciUpperLimit': '-0.41', 'pValueComment': 'P-value from Type III F-test', 'groupDescription': 'Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.05', 'ciLowerLimit': '-1.49', 'ciUpperLimit': '-0.60', 'pValueComment': 'P-value from Type III F-test', 'groupDescription': 'Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.07', 'ciLowerLimit': '-1.52', 'ciUpperLimit': '-0.63', 'pValueComment': 'P-value from Type III F-test', 'groupDescription': 'Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 2, Week 6 and Week 12', 'description': 'The fasting plasma glucose (FPG) was analyzed on the full analysis set using the same MMRM ANCOVA model used in the primary efficacy analysis.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subject with a value at the specified time is included'}, {'type': 'SECONDARY', 'title': 'Change in Systolic and Diastolic Blood Pressure Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once daily before breakfast\n\nPlacebo tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG001', 'title': 'Bexagliflozin 5 mg', 'description': 'Bexagliflozin tablet, 5 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG002', 'title': 'Bexagliflozin 10 mg', 'description': 'Bexagliflozin tablet, 10 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG003', 'title': 'Bexagliflozin 20 mg', 'description': 'Bexagliflozin tablet, 20 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}], 'classes': [{'title': 'Week 2 SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '1.43', 'groupId': 'OG001'}, {'value': '-2.55', 'spread': '1.42', 'groupId': 'OG002'}, {'value': '-4.39', 'spread': '1.38', 'groupId': 'OG003'}]}]}, {'title': 'Week 2 DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '-1.59', 'spread': '0.88', 'groupId': 'OG002'}, {'value': '-2.00', 'spread': '0.86', 'groupId': 'OG003'}]}]}, {'title': 'Week 6 SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.57', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '-1.40', 'spread': '1.45', 'groupId': 'OG001'}, {'value': '-3.96', 'spread': '1.44', 'groupId': 'OG002'}, {'value': '-3.07', 'spread': '1.39', 'groupId': 'OG003'}]}]}, {'title': 'Week 6 DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.93', 'groupId': 'OG001'}, {'value': '-1.54', 'spread': '0.92', 'groupId': 'OG002'}, {'value': '-0.36', 'spread': '0.89', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.10', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '1.57', 'groupId': 'OG001'}, {'value': '-3.30', 'spread': '1.55', 'groupId': 'OG002'}, {'value': '-2.73', 'spread': '1.55', 'groupId': 'OG003'}]}]}, {'title': 'Week 12 DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '-1.43', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '-0.66', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '-1.23', 'spread': '0.94', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-3.90', 'ciUpperLimit': '3.51', 'groupDescription': 'Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.41', 'ciLowerLimit': '-6.09', 'ciUpperLimit': '1.28', 'groupDescription': 'Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.25', 'ciLowerLimit': '-7.93', 'ciUpperLimit': '-0.58', 'groupDescription': 'Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-2.50', 'ciUpperLimit': '2.13', 'groupDescription': 'Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.74', 'ciLowerLimit': '-4.03', 'ciUpperLimit': '0.56', 'groupDescription': 'Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.15', 'ciLowerLimit': '-4.45', 'ciUpperLimit': '0.14', 'groupDescription': 'Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.84', 'ciLowerLimit': '-4.57', 'ciUpperLimit': '2.90', 'groupDescription': 'Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.39', 'ciLowerLimit': '-7.12', 'ciUpperLimit': '0.34', 'groupDescription': 'Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.51', 'ciLowerLimit': '-6.21', 'ciUpperLimit': '1.20', 'groupDescription': 'Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-2.15', 'ciUpperLimit': '2.66', 'groupDescription': 'Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.02', 'ciLowerLimit': '-3.42', 'ciUpperLimit': '1.38', 'groupDescription': 'Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.84', 'ciLowerLimit': '-3.22', 'ciUpperLimit': '1.54', 'groupDescription': 'Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.16', 'ciLowerLimit': '-6.26', 'ciUpperLimit': '1.94', 'pValueComment': 'P-value from Type III F-test', 'groupDescription': 'Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates'}, {'pValue': '0.0343', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.41', 'ciLowerLimit': '-8.49', 'ciUpperLimit': '-0.33', 'pValueComment': 'P-value from Type III F-test', 'groupDescription': 'Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates'}, {'pValue': '0.0679', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.83', 'ciLowerLimit': '-7.95', 'ciUpperLimit': '0.28', 'groupDescription': 'Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates'}, {'pValue': '0.0776', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.24', 'ciLowerLimit': '-4.73', 'ciUpperLimit': '0.25', 'pValueComment': 'P-value from Type III F-test', 'groupDescription': 'Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates'}, {'pValue': '0.2415', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.47', 'ciLowerLimit': '-3.95', 'ciUpperLimit': '1.00', 'pValueComment': 'P-value from Type III F-test', 'groupDescription': 'Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates'}, {'pValue': '0.1086', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.04', 'ciLowerLimit': '-4.54', 'ciUpperLimit': '0.46', 'pValueComment': 'P-value from Type III F-test', 'groupDescription': 'Week 12: Difference in LS mean change in DBP from baseline to week 12 was 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{'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablet once daily before breakfast\n\nPlacebo tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG001', 'title': 'Bexagliflozin 5 mg', 'description': 'Bexagliflozin tablet, 5 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG002', 'title': 'Bexagliflozin 10 mg', 'description': 'Bexagliflozin tablet, 10 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'OG003', 'title': 'Bexagliflozin 20 mg', 'description': 'Bexagliflozin tablet, 20 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for 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'0.06', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '-0.44', 'spread': '0.08', 'groupId': 'OG002'}, {'value': '-0.56', 'spread': '0.08', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.03', 'groupDescription': 'Week 2: Difference in LS Mean change in HbA1c (%) from baseline to Week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS 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'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '-0.34', 'pValueComment': 'P-value from Type III F-test', 'groupDescription': 'Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.68', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '-0.47', 'pValueComment': 'P-value from Type III F-test', 'groupDescription': 'Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-1.01', 'ciUpperLimit': '-0.59', 'pValueComment': 'P-value from Type III F-test', 'groupDescription': 'Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 2, Week 6 and Week 12', 'description': 'The least square mean (LSM) change from baseline to Week 2, Week 6 and Week 12 was analyzed using the Mixed-Effect Model Repeated Measure (MMRM) Analysis of Covariance (ANCOVA) model using 95% Confidence Intervals (CIs) for the between-group mean changes. The LSM change was calculated by excluding HbA1c data obtained after rescue medication.', 'unitOfMeasure': 'percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subject with a value at the specified time is included'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo tablet once daily before breakfast\n\nPlacebo tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'FG001', 'title': 'Bexagliflozin 5 mg', 'description': 'Bexagliflozin tablet, 5 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'FG002', 'title': 'Bexagliflozin 10 mg', 'description': 'Bexagliflozin tablet, 10 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that 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'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '292', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo tablet once daily before breakfast\n\nPlacebo tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'BG001', 'title': 'Bexagliflozin 5 mg', 'description': 'Bexagliflozin tablet, 5 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.'}, {'id': 'BG002', 'title': 'Bexagliflozin 10 mg', 'description': 'Bexagliflozin tablet, 10 mg, once daily before breakfast\n\nBexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for 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'25', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '112', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '180', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '231', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '155', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '103', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '142', 'groupId': 'BG004'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '150', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '165.6', 'spread': '10.63', 'groupId': 'BG000'}, {'value': '165.7', 'spread': '9.25', 'groupId': 'BG001'}, {'value': '165.8', 'spread': '9.03', 'groupId': 'BG002'}, {'value': '166.0', 'spread': '10.33', 'groupId': 'BG003'}, {'value': '165.8', 'spread': '9.79', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '78.72', 'spread': '19.747', 'groupId': 'BG000'}, {'value': '80.52', 'spread': '18.977', 'groupId': 'BG001'}, {'value': '78.39', 'spread': '17.589', 'groupId': 'BG002'}, {'value': '78.84', 'spread': '16.740', 'groupId': 'BG003'}, {'value': '79.11', 'spread': '18.204', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '28.54', 'spread': '5.535', 'groupId': 'BG000'}, {'value': '29.10', 'spread': '5.211', 'groupId': 'BG001'}, {'value': '28.35', 'spread': '4.978', 'groupId': 'BG002'}, {'value': '28.49', 'spread': '5.010', 'groupId': 'BG003'}, {'value': '28.62', 'spread': '5.167', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-02-16', 'size': 1095589, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-01T14:22', 'hasProtocol': True}, {'date': '2015-10-21', 'size': 684105, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-01T14:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'dispFirstSubmitDate': '2016-07-11', 'completionDateStruct': {'date': '2016-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-11', 'studyFirstSubmitDate': '2015-03-11', 'dispFirstSubmitQcDate': '2016-07-12', 'resultsFirstSubmitDate': '2021-03-25', 'studyFirstSubmitQcDate': '2015-03-16', 'dispFirstPostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-25', 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c After 12 Weeks of Treatment', 'timeFrame': '12 weeks', 'description': 'Mixed model repeated measures (MMRM) analysis of covariance model (ANCOVA) with baseline HbA1c as a covariate will be fit to the available data, incorporating all visits at which HbA1c was measured for each subject including scheduled visits at Weeks 2, 6, and 12 as well as unscheduled visits for measurements of HbA1c. Treatment (placebo, 5 mg, 10 mg, 20 mg), study center, prior anti-diabetic treatment status, study visit and treatment-by-visit interaction will be applied as fixed effects and subject as a random effect. The least square mean (LSM) change from baseline to Week 12 was analyzed using the Mixed-Effect Model Repeated Measure (MMRM) Analysis of Covariance (ANCOVA) model using 95% Confidence Intervals (CIs) for the between-group mean changes.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects With HbA1c < 7%', 'timeFrame': 'Baseline to up to 12 weeks', 'description': 'To assess the efficacy of bexagliflozin based on the proportion of subjects who reach the American Diabetes Associate (ADA) and the Japan Diabetes Society target HbA1c of \\<7%.'}, {'measure': 'Change in Body Weight Over Time', 'timeFrame': 'Baseline to Week 2, Week 6 and Week 12', 'description': 'The body weight was analyzed on the full analysis set using the MMRM ANCOVA model used for the primary efficacy analysis.'}, {'measure': 'Change in Fasting Plasma Glucose (FPG) Over Time', 'timeFrame': 'Baseline to Week 2, Week 6 and Week 12', 'description': 'The fasting plasma glucose (FPG) was analyzed on the full analysis set using the same MMRM ANCOVA model used in the primary efficacy analysis.'}, {'measure': 'Change in Systolic and Diastolic Blood Pressure Over Time', 'timeFrame': 'Baseline to Week 2, Week 6 and Week 12', 'description': 'The systolic blood pressure (SBP) and diastolic blood pressure (DBP) were analyzed on the full analysis set using the same MMRM ANCOVA model used in the primary efficacy analysis.'}, {'measure': 'Change in HbA1c Over Time', 'timeFrame': 'Baseline to Week 2, Week 6 and Week 12', 'description': 'The least square mean (LSM) change from baseline to Week 2, Week 6 and Week 12 was analyzed using the Mixed-Effect Model Repeated Measure (MMRM) Analysis of Covariance (ANCOVA) model using 95% Confidence Intervals (CIs) for the between-group mean changes. The LSM change was calculated by excluding HbA1c data obtained after rescue medication.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '24357209', 'type': 'BACKGROUND', 'citation': 'American Diabetes Association. Standards of medical care in diabetes--2014. Diabetes Care. 2014 Jan;37 Suppl 1:S14-80. doi: 10.2337/dc14-S014. No abstract available.'}, {'pmid': '23796131', 'type': 'BACKGROUND', 'citation': 'Look AHEAD Research Group; Wing RR, Bolin P, Brancati FL, Bray GA, Clark JM, Coday M, Crow RS, Curtis JM, Egan CM, Espeland MA, Evans M, Foreyt JP, Ghazarian S, Gregg EW, Harrison B, Hazuda HP, Hill JO, Horton ES, Hubbard VS, Jakicic JM, Jeffery RW, Johnson KC, Kahn SE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montez MG, Murillo A, Nathan DM, Patricio J, Peters A, Pi-Sunyer X, Pownall H, Reboussin D, Regensteiner JG, Rickman AD, Ryan DH, Safford M, Wadden TA, Wagenknecht LE, West DS, Williamson DF, Yanovski SZ. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med. 2013 Jul 11;369(2):145-54. doi: 10.1056/NEJMoa1212914. Epub 2013 Jun 24.'}, {'pmid': '19339088', 'type': 'BACKGROUND', 'citation': 'Matsuo S, Imai E, Horio M, Yasuda Y, Tomita K, Nitta K, Yamagata K, Tomino Y, Yokoyama H, Hishida A; Collaborators developing the Japanese equation for estimated GFR. Revised equations for estimated GFR from serum creatinine in Japan. Am J Kidney Dis. 2009 Jun;53(6):982-92. doi: 10.1053/j.ajkd.2008.12.034. Epub 2009 Apr 1.'}, {'pmid': '24983040', 'type': 'BACKGROUND', 'citation': 'National Research Council (US) Panel on Handling Missing Data in Clinical Trials. The Prevention and Treatment of Missing Data in Clinical Trials. Washington (DC): National Academies Press (US); 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK209904/'}, {'pmid': '20680014', 'type': 'BACKGROUND', 'citation': 'Palaniappan LP, Wong EC, Shin JJ, Fortmann SP, Lauderdale DS. Asian Americans have greater prevalence of metabolic syndrome despite lower body mass index. Int J Obes (Lond). 2011 Mar;35(3):393-400. doi: 10.1038/ijo.2010.152. Epub 2010 Aug 3.'}, {'pmid': '14569097', 'type': 'BACKGROUND', 'citation': 'Santer R, Kinner M, Lassen CL, Schneppenheim R, Eggert P, Bald M, Brodehl J, Daschner M, Ehrich JH, Kemper M, Li Volti S, Neuhaus T, Skovby F, Swift PG, Schaub J, Klaerke D. Molecular analysis of the SGLT2 gene in patients with renal glucosuria. J Am Soc Nephrol. 2003 Nov;14(11):2873-82. doi: 10.1097/01.asn.0000092790.89332.d2.'}, {'pmid': '24731666', 'type': 'BACKGROUND', 'citation': 'Scheen AJ, Van Gaal LF. Combating the dual burden: therapeutic targeting of common pathways in obesity and type 2 diabetes. Lancet Diabetes Endocrinol. 2014 Nov;2(11):911-22. doi: 10.1016/S2213-8587(14)70004-X. Epub 2014 Feb 19.'}, {'pmid': '23393695', 'type': 'BACKGROUND', 'citation': 'Schwartz S, Fabricatore AN, Diamond A. Weight reduction in diabetes. Adv Exp Med Biol. 2012;771:438-58. doi: 10.1007/978-1-4614-5441-0_31.'}, {'pmid': '12436245', 'type': 'BACKGROUND', 'citation': 'van den Heuvel LP, Assink K, Willemsen M, Monnens L. Autosomal recessive renal glucosuria attributable to a mutation in the sodium glucose cotransporter (SGLT2). Hum Genet. 2002 Dec;111(6):544-7. doi: 10.1007/s00439-002-0820-5. Epub 2002 Sep 27.'}, {'type': 'BACKGROUND', 'citation': 'Japan Diabetes Society (2012). Treatment Guidance for Diabetes 2012-2013.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM). Bexagliflozin is an orally administered drug for the treatment of T2DM and is classified as a Sodium Glucose co-Transporter 2 (SGLT2) Inhibitor. This study was to enroll both treatment naive and those subjects previously treated with one oral hypoglycemic agent (OHA). Approximately 320 subjects eligible for randomization was to receive bexagliflozin tablets, 5, 10, 20 mg or placebo, once daily for 12 weeks in an outpatient setting.', 'detailedDescription': 'The study was a phase 2b multicenter, double-blind, placebo-controlled parallel group study to assess the effect of once daily bexagliflozin tablets on HbA1c in either treatment-naïve T2DM subjects or in subjects who were treated with one oral anti-diabetic agent. Treatment naïve subjects were eligible if their HbA1c values were between 7% and 8.5% at the screening visit while subjects who were treated with one oral hypoglycemic agent (OHA) were eligible if their HbA1c value was between 6.5% and 8.5% at screening and underwent a 6 or 10 week washout period. In addition, all eligible subjects underwent a two week placebo run-in period and those who showed good compliance in taking study medication (i.e., missed no more than one dose during the run-in period) during this period and whose HbA1c values were between 7 and 8.5% at the end of the run-in period were eligible for randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "The following subjects were eligible for randomization:\n\n1. men or women ≥ 20 years of age at screening. Women of childbearing potential must test negative by urine pregnancy test.\n2. were treatment naïve or taking one oral anti-diabetic medication in combination with diet and exercise\n3. were diagnosed with T2DM with HbA1c levels at screening between 7.0% and 8.5% (inclusive) if treatment naïve or with HbA1c levels between 6.5 and 8.5% (inclusive) if on one oral anti-diabetic medication\n4. had a body mass index (BMI) ≤ 40 kg/m2\n5. were taking stable doses of medication for hypertension or hyperlipidemia that has not changed for at least 30 days prior to screening (if applicable)\n6. were able to comprehend the study participation requirements and willing to provide written informed consent in accordance with institutional and regulatory guidelines\n7. were able to maintain adequate glycemic control at the run-in visit (for subjects who complete the washout)\n8. had an HbA1c between 7.0 and 8.5% (inclusive) prior to randomization (day -3 to -5)\n9. were capable of adhering to the investigational product administration requirements as evidenced by omission of no more than one dose of run-in medication\n\nSubjects who exhibited any of the following characteristics were to be ineligible for randomization:\n\n1. Diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young\n2. Used parenteral therapy for treatment of diabetes\n3. Pregnancy or current breastfeeding status\n4. Hemoglobinopathy or carrier status for hemoglobin alleles that affect HbA1c measurement\n5. Genitourinary tract infection within 6 weeks of screening or history of ≥3 genitourinary infections requiring treatment within 6 months of screening\n6. Estimated glomerular filtration rate (eGFR) \\< 60 mL/min/1.73 m2 at screening.\n7. Uncontrolled hypertension at screening\n8. A positive result on hepatitis B surface antigen, hepatitis C, or positive result from screen for drugs of abuse\n9. History of human immunodeficiency virus infection\n10. Life expectancy \\< 2 years\n11. History of New York Heart Association Class 4 heart failure within 3 months of screening\n12. History of myocardial infarction, unstable angina, stroke, or hospitalization for heart failure within 3 months of screening\n13. History of treatment with an investigational drug within 30 days or within 7 half lives of the investigational drug, whichever is longer\n14. Previous treatment with bexagliflozin\n15. Had taken or within 6 months of taking any Sodium Glucose Transporter 2 (SGLT2) inhibitors prior to screening\n16. Participation of another interventional trial\n17. Not able to comply with the study scheduled visits\n18. Affected by any condition, disease, disorder, or clinically relevant abnormality that, in the opinion of the investigator, would jeopardize the subject's appropriate participation in this study.\n19. Liver function tests resulting in Alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 2.5 x upper limit of normal (ULN) or total bilirubin ≥ 1.5 x ULN, with the exception of isolated Gilbert's syndrome ,at screening\n20. Exhibited fasting plasma glucose ≥ 250 mg/dL (13.9 mmol/L) on two or more consecutive days prior to randomization or exhibited severe clinical signs or symptoms of hyperglycemia during the washout or run-in periods, including weight loss, blurred vision, increased thirst, or increased urination, or fatigue\n21. Fasting Plasma Glucose ≥ 250 mg/dL at randomization\n22. Prior renal transplantation or evidence of nephrotic syndrome, defined as a urine albumin-to-creatinine ratio (UACR) \\> 2000 mg/g at screening"}, 'identificationModule': {'nctId': 'NCT02390050', 'briefTitle': 'A Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets in Subjects With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theracos'}, 'officialTitle': 'A Phase 2b, Multi-center, Double-blind, Placebo-controlled, Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets on HbA1c in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'THR-1442-C-449'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bexagliflozin tablets, 5 mg', 'description': 'Bexagliflozin tablets, 5 mg, once daily by mouth before breakfast', 'interventionNames': ['Drug: Bexagliflozin tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bexagliflozin tablets, 10 mg', 'description': 'Bexagliflozin tablets, 10 mg, once daily by mouth before breakfast', 'interventionNames': ['Drug: Bexagliflozin tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bexagliflozin tablets, 20 mg', 'description': 'Bexagliflozin tablets, 20 mg, once daily by mouth before breakfast', 'interventionNames': ['Drug: Bexagliflozin tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Bexagliflozin tablets, placebo', 'description': 'Bexagliflozin tablets, placebo, once daily by mouth before breakfast', 'interventionNames': ['Drug: Bexagliflozin tablets, placebo']}], 'interventions': [{'name': 'Bexagliflozin tablets', 'type': 'DRUG', 'otherNames': ['Code name: EGT0001442'], 'description': 'Bexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.', 'armGroupLabels': ['Bexagliflozin tablets, 10 mg', 'Bexagliflozin tablets, 20 mg', 'Bexagliflozin tablets, 5 mg']}, {'name': 'Bexagliflozin tablets, placebo', 'type': 'DRUG', 'description': 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