Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-01 @ 10:23 AM
Study NCT ID:
NCT02981069
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2016-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Chronic Exenatide Therapy on Beta Cell Function and Insulin Sensitivity in T2DM
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}}}}, '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': 'C529054', 'term': 'dapagliflozin'}, {'id': 'D000077270', 'term': 'Exenatide'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cersosimo@uthscsa.edu', 'phone': '12103587200', 'title': 'Professor', 'organization': 'University of Texas Health San Antonio'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline to 6 months', 'description': 'Patient reporting and physical exam by principal investigator/nurse coordinator', 'eventGroups': [{'id': 'EG000', 'title': 'Byetta / Bydureon', 'description': 'Exenatide:\n\n4 weeks of exenatide 5 mcg twice daily followed by Bydureon 2mg sc weekly\n\nExenatide: Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly)', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 6, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dapagliflozin', 'description': '16 weeks Dapagliflozin, Farxiga, 10mg\n\nDapagliflozin: 10mg', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 4, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Byetta/Bydureon Plus Dapagliflozin', 'description': 'Exenatide:\n\n4 weeks of exenatide followed by 12 weeks of Bydureon 2mg sc once weekly PLUS\n\nDapagliflozin:\n\n16 weeks Dapagliflozin, Farxiga, 10mg\n\nDapagliflozin: 10mg\n\nExenatide: Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly)', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 7, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': '16 weeks of placebo administration', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Genital Mycosis', 'notes': 'Nausea and Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea and Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Endogenous Glucose Production (EGP) After Acute Exposure to a Single Dose and Again After 16 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EXENATIDE', 'description': 'Exenatide:\n\nAfter acute exposure to a single dose of Exenatide, 5 mcg.'}, {'id': 'OG001', 'title': 'Dapagliflozin', 'description': 'After acute single dose exposure of Dapagliflozin, Farxiga, 10mg'}, {'id': 'OG002', 'title': 'Exenatide Plus Dapagliflozin', 'description': 'After acute exposure to both dapagliflozin, farxiga 10 mg orally and a single subcutaneous injection of Exenatide'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'After a single dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.03', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '0.02', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'ACUTE [after a single dose of each study drug or placebo]', 'description': 'After screening, eligible subjects will receive a measurement of endogenous glucose production (EGP) with a prime-continuous infusion of 3-3H-glucose. The EGP measurement will be performed in the morning after a 10-12 hour overnight fast and will last 8.5 hours (from 6 AM to 2:30 PM). After a 3.5-hour tracer equilibration period, subjects (20 per group) will receive one of the following medications: (i) placebo; (ii) exenatide 5 ug subcutaneously; (iii) dapagliflozin (10 mg); and (iv) dapagliflozin 10 mg + exenatide 5 ug \\[ACUTE STUDY\\].', 'unitOfMeasure': 'mg/kg.min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Type 2 diabetes'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (FPG) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Byetta / Bydureon', 'description': 'Exenatide:\n\n4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc\n\nExenatide: Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly)'}, {'id': 'OG001', 'title': 'Dapagliflozin', 'description': '4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg\n\nDapagliflozin: 10mg'}, {'id': 'OG002', 'title': 'Byetta/Bydureon Plus Dapagliflozin', 'description': 'Exenatide:\n\n4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc PLUS\n\nDapagliflozin:\n\n4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg\n\nDapagliflozin: 10mg\n\nExenatide: Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly)'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'spread': '1', 'groupId': 'OG000'}, {'value': '72', 'spread': '3', 'groupId': 'OG001'}, {'value': '11', 'spread': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'The change in (FPG) above baseline following administration of study interventions after 16 weeks of treatment with each study drug(s) compared to data obtained during the acute exposure. Placebo arm was not included in this 16 week portion of the study, since subjects are diabetic. Only 3 arms of the study were conducted: (i) Byetta/Bydureon, (ii) Dapagliflozin (iii) Byetta/Bydureon plus Dapagliflozin.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'type 2 diabetes'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Glucagon Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapa+Exe', 'description': 'Combination dapagliflozin plus exenatide therapy'}, {'id': 'OG001', 'title': 'Dapa', 'description': 'Dapagliflozin therapy for 16 weeks'}, {'id': 'OG002', 'title': 'Exenatide', 'description': 'Exenatide therapy for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '2', 'groupId': 'OG000'}, {'value': '5', 'spread': '2', 'groupId': 'OG001'}, {'value': '-6', 'spread': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 16 weeks', 'description': 'Measurement of change in plasma glucagon concentration after 16 weeks of treatment with each study drug(s) compared to acute exposure at baseline. Placebo arm was not included in this 16 week portion of the study, since subjects are diabetic. Only 3 arms of the study were conducted: (i) Byetta/Bydureon, (ii) Dapagliflozin (iii) Byetta/Bydureon plus Dapagliflozin.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'type 2 diabetes'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Insulin Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapa+Exe', 'description': 'Therapy for 16 weeks with combination exenatide plus dapagliflozin'}, {'id': 'OG001', 'title': 'Dapa', 'description': 'Dapagliflozin therapy for 16 weeks'}, {'id': 'OG002', 'title': 'Exenatide', 'description': 'Exenatide therapy for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2', 'spread': '1', 'groupId': 'OG000'}, {'value': '-2', 'spread': '2', 'groupId': 'OG001'}, {'value': '3', 'spread': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 16 weeks', 'description': 'Measurement of change in plasma insulin concentration from baseline to 16 weeks following treatment with each study drug(s). Placebo arm was not included in this 16 week portion of the study, since subjects are diabetic. Only 3 arms of the study were conducted: (i) Byetta/Bydureon, (ii) Dapagliflozin (iii) Byetta/Bydureon plus Dapagliflozin.', 'unitOfMeasure': 'microUnits/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Type 2 diabetes'}, {'type': 'PRIMARY', 'title': 'Change in Endogenous Glucose Production (EGP) After 16 Weeks of Treatment With Each Study Drug.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EXENATIDE', 'description': 'Exenatide:\n\nAfter 16 weeks of treatment with Exenatide, starting with 5 mcg twice daily and at 4 weeks changed to 2 mg once weekly subcutaneously.'}, {'id': 'OG001', 'title': 'Dapagliflozin', 'description': 'After 16 weeks of treatment with Dapagliflozin, Farxiga, 10mg'}, {'id': 'OG002', 'title': 'Exenatide Plus Dapagliflozin', 'description': 'After 16 weeks of therapy with both drugs in combination.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '-0.12', 'spread': '0.03', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'After screening, eligible subjects will receive a measurement of endogenous glucose production (EGP) with a prime-continuous infusion of 3-3H-glucose. The EGP measurement will be performed in the morning after a 10-12 hour overnight fast and will last 8.5 hours (from 6 AM to 2:30 PM). After a 3.5-hour tracer equilibration period, subjects (20 per group) will receive one of the following medications: (i) exenatide 5 ug subcutaneously; (ii) dapagliflozin (10 mg); and (iii) dapagliflozin 10 mg + exenatide 5 ug. Only three groups will be followed for 16 weeks since subjects are diabetic and placebo is not appropriate to use for this period. Again, subjects will be randomized to treatment with either exenatide, dapagliflozin or both drugs in combination. Repeat EGP will be measured again at 16 weeks as described above and data will be compared to respective "acute" studies.', 'unitOfMeasure': 'mg/kg.min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Type 2 diabetes'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Byetta / Bydureon', 'description': 'Exenatide:\n\n4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc\n\nExenatide: Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly)'}, {'id': 'FG001', 'title': 'Dapagliflozin', 'description': '4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg\n\nDapagliflozin: 10mg'}, {'id': 'FG002', 'title': 'Byetta/Bydureon Plus Dapagliflozin', 'description': 'Exenatide:\n\n4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc PLUS\n\nDapagliflozin:\n\n4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg\n\nDapagliflozin: 10mg\n\nExenatide: Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly)'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo group (4 weeks and 12 weeks)\n\nPlacebo: Placebo for Dapagliflozin'}], 'periods': [{'title': 'Acute Portion of Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': '16 Week Drug Administration Period', 'milestones': [{'type': 'STARTED', 'comment': 'Since subjects are Type 2 diabetics, there was no placebo arm for this portion of the study. Only 3 arms of the study were conducted: (i) Byetta/Bydureon, (ii) Dapagliflozin (iii) Byetta/Bydureon plus Dapagliflozin.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Type 2 diabetes with significant clinical complications were excluded'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Byetta / Bydureon', 'description': 'Exenatide:\n\n4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc\n\nExenatide: Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly)'}, {'id': 'BG001', 'title': 'Dapagliflozin', 'description': '4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg\n\nDapagliflozin: 10mg'}, {'id': 'BG002', 'title': 'Byetta/Bydureon Plus Dapagliflozin', 'description': 'Exenatide:\n\n4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc PLUS\n\nDapagliflozin:\n\n4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg\n\nDapagliflozin: 10mg\n\nExenatide: Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly)'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo group (4 weeks and 12 weeks)\n\nPlacebo: Placebo for Dapagliflozin'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '3', 'groupId': 'BG000'}, {'value': '51', 'spread': '2', 'groupId': 'BG001'}, {'value': '49', 'spread': '4', 'groupId': 'BG002'}, {'value': '54', 'spread': '3', 'groupId': 'BG003'}, {'value': '52', 'spread': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', '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': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-08', 'size': 424091, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-13T10:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-28', 'studyFirstSubmitDate': '2016-11-30', 'resultsFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2016-11-30', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-28', 'studyFirstPostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Endogenous Glucose Production (EGP) After Acute Exposure to a Single Dose and Again After 16 Weeks of Treatment', 'timeFrame': 'ACUTE [after a single dose of each study drug or placebo]', 'description': 'After screening, eligible subjects will receive a measurement of endogenous glucose production (EGP) with a prime-continuous infusion of 3-3H-glucose. The EGP measurement will be performed in the morning after a 10-12 hour overnight fast and will last 8.5 hours (from 6 AM to 2:30 PM). After a 3.5-hour tracer equilibration period, subjects (20 per group) will receive one of the following medications: (i) placebo; (ii) exenatide 5 ug subcutaneously; (iii) dapagliflozin (10 mg); and (iv) dapagliflozin 10 mg + exenatide 5 ug \\[ACUTE STUDY\\].'}, {'measure': 'Change in Endogenous Glucose Production (EGP) After 16 Weeks of Treatment With Each Study Drug.', 'timeFrame': '16 weeks', 'description': 'After screening, eligible subjects will receive a measurement of endogenous glucose production (EGP) with a prime-continuous infusion of 3-3H-glucose. The EGP measurement will be performed in the morning after a 10-12 hour overnight fast and will last 8.5 hours (from 6 AM to 2:30 PM). After a 3.5-hour tracer equilibration period, subjects (20 per group) will receive one of the following medications: (i) exenatide 5 ug subcutaneously; (ii) dapagliflozin (10 mg); and (iii) dapagliflozin 10 mg + exenatide 5 ug. Only three groups will be followed for 16 weeks since subjects are diabetic and placebo is not appropriate to use for this period. Again, subjects will be randomized to treatment with either exenatide, dapagliflozin or both drugs in combination. Repeat EGP will be measured again at 16 weeks as described above and data will be compared to respective "acute" studies.'}], 'secondaryOutcomes': [{'measure': 'Change in Fasting Plasma Glucose (FPG) Concentration', 'timeFrame': '16 weeks', 'description': 'The change in (FPG) above baseline following administration of study interventions after 16 weeks of treatment with each study drug(s) compared to data obtained during the acute exposure. Placebo arm was not included in this 16 week portion of the study, since subjects are diabetic. Only 3 arms of the study were conducted: (i) Byetta/Bydureon, (ii) Dapagliflozin (iii) Byetta/Bydureon plus Dapagliflozin.'}, {'measure': 'Change in Plasma Glucagon Concentration', 'timeFrame': 'Baseline to 16 weeks', 'description': 'Measurement of change in plasma glucagon concentration after 16 weeks of treatment with each study drug(s) compared to acute exposure at baseline. Placebo arm was not included in this 16 week portion of the study, since subjects are diabetic. Only 3 arms of the study were conducted: (i) Byetta/Bydureon, (ii) Dapagliflozin (iii) Byetta/Bydureon plus Dapagliflozin.'}, {'measure': 'Change in Plasma Insulin Concentration', 'timeFrame': 'Baseline to 16 weeks', 'description': 'Measurement of change in plasma insulin concentration from baseline to 16 weeks following treatment with each study drug(s). Placebo arm was not included in this 16 week portion of the study, since subjects are diabetic. Only 3 arms of the study were conducted: (i) Byetta/Bydureon, (ii) Dapagliflozin (iii) Byetta/Bydureon plus Dapagliflozin.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'In this study, the researchers hope to learn about SGLT2 inhibition on EGP (endogenous glucose production) and plasma glucose concentration in diabetic subjects. Researchers will examine diabetes and the role of increased plasma glucagon, decline in plasma insulin, and fall in plasma glucose concentration.', 'detailedDescription': 'This study will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose concentration compared to each agent alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. BMI = 25-35 kg/m\\^2\n2. must be drug naïve and/or on a stable dose (more than 3 months) of metformin and/or sulfonylurea\n3. HbA1c \\>7.0% and \\<10.0%\n4. Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, EKG and urinanalysis.\n5. Only subjects whose body weight has been stable (± 3 lbs) over the preceding three months and who do not participate in an excessively heavy exercise program will be included.\n\nExclusion Criteria:\n\n1. Presence of significant systemic disease, heart problems including congestive heart failure, unstable angina or acute myocardial infarction, current infectious liver disease, acute stroke or transient ischemic attacks, history of pancreatitis, urosepsis and pyelonephritis, genital mycotic infections, or Type 1 diabetes mellitus\n2. Any hepatic diseases in the past (infectious liver disease, viral hepatitis, toxic hepatic damage, jaundice of unknown etiology) or severe hepatic insufficiency and/or significant abnormal liver function tests defined as aspartate aminotransferase (AST) \\>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \\>3x ULN\n3. Renal impairment (e.g., serum creatinine levels ≥1.4 mg/dL for women or ≥1.5 mg/dl for men, or eGFR \\<60 mL/min/1.73 m2) or history of unstable or rapidly progressing renal disease or end stage renal disease.\n4. Uncontrolled thyroid disease , Cushing's syndrome, congenital adrenal hyperplasia or hyperprolactinemia\n5. Significantly elevated triglyceride levels (fasting triglyceride \\> 400 mg/dl), uncontrolled increased LDL-C\n6. Untreated or poorly controlled hypertension (sitting blood pressure \\> 160/95 mm Hg)\n7. Use of anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, , GnRH agonists, glucocorticoids, anabolic steroids, C-19 progestins) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors (finesteride, spironolactone, flutamide) stopped for at least 4 weeks\n8. Prior history of a malignant disease requiring chemotherapy, prior history of bladder cancer regardless treatment\n9. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status\n10. History of unexplained microscopic or gross hematuria, or microscopic hematuria at visit 1, confirmed by a follow-up sample at next scheduled visit.\n11. Presence of hypersensitivity to dapagliflozin or other SGLT2 inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions\n12. Known hypersensitivity or contraindications to use GLP1 receptor agonists (exenatide, liraglutide)\n13. Use of , thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors stopped for at least 8 weeks.\n14. Eating disorders (anorexia, bulimia) or gastrointestinal disorders\n15. Suspected pregnancy (documented negative serum β-hCG test), desiring pregnancy in next 6 months, breastfeeding, or known pregnancy in last 2 months\n16. Active history of illicit substance abuse or significant intake of alcohol\n17. Having a history of bariatric surgery\n18. Patient not willing to use two barrier method contraception during study period (unless sterilized or have an IUD)\n19. Debilitating uncontrolled psychiatric disorder such as psychosis or neurological condition that might confound outcome variables\n20. Inability or refusal to comply with protocol\n21. Current participation or participation in an experimental drug study in previous three months"}, 'identificationModule': {'nctId': 'NCT02981069', 'briefTitle': 'Effect of Chronic Exenatide Therapy on Beta Cell Function and Insulin Sensitivity in T2DM', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Effect of Chronic Exenatide Therapy on Beta Cell Function and Insulin Sensitivity in Type 2 Diabetes Mellitus (T2DM)', 'orgStudyIdInfo': {'id': 'HSC20160597H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Byetta / Bydureon', 'description': 'Exenatide:\n\n4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc', 'interventionNames': ['Drug: Exenatide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dapagliflozin', 'description': '4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Byetta/Bydureon plus Dapagliflozin', 'description': 'Exenatide:\n\n4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc PLUS\n\nDapagliflozin:\n\n4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg', 'interventionNames': ['Drug: Dapagliflozin', 'Drug: Exenatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo group (4 weeks and 12 weeks)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'otherNames': ['Farxiga'], 'description': '10mg', 'armGroupLabels': ['Byetta/Bydureon plus Dapagliflozin', 'Dapagliflozin']}, {'name': 'Exenatide', 'type': 'DRUG', 'otherNames': ['Byetta, Bydureon'], 'description': 'Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly)', 'armGroupLabels': ['Byetta / Bydureon', 'Byetta/Bydureon plus Dapagliflozin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for Dapagliflozin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Eugenio Cersosimo, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}