Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-25 @ 9:46 PM
Study NCT ID:
NCT02962492
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2016-11-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007662', 'term': 'Ketosis'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077270', 'term': 'Exenatide'}, {'id': 'C529054', 'term': 'dapagliflozin'}], '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': 'dandona@buffalo.edu', 'phone': '7165351850', 'title': 'Dr. Paresh Dandona', 'organization': 'State University of NY at Buffalo'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Patients were mainly monitored for 2 adverse events (also considered serious adverse events) throughout the study (12 weeks) related to:\n\n1. severe hypoglycemia (blood sugar \\<35mg/dl and requiring assistance)\n2. diagnosis of diabetic ketoacidosis', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Arm:', 'description': 'dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)\n\nPlacebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dapagliflozin Arm:', 'description': 'dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)\n\nDapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Exenatide Extended Release Arm:', 'description': 'subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo\n\nExenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Exenatide Extended Release & Dapagliflozin Arm:', 'description': 'Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg\n\nExenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks\n\nDapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Severe Hypoglycemia', 'notes': 'severe hypoglycemia (blood sugar \\<35mg/dl and requiring assistance)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic Ketoacidosis', 'notes': 'Diagnosis or hospitalization due to diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Beta-hydroxybutyrate Levels in Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm:', 'description': 'dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)\n\nPlacebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'OG001', 'title': 'Dapagliflozin Arm:', 'description': 'dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)\n\nDapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'OG002', 'title': 'Exenatide Extended Release Arm:', 'description': 'subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo\n\nExenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'OG003', 'title': 'Exenatide Extended Release & Dapagliflozin Arm:', 'description': 'Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg\n\nExenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks\n\nDapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '0.24', 'spread': '0.21', 'groupId': 'OG002'}, {'value': '0.31', 'spread': '0.19', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Beta-hydroxybutyrate (BHB) was measured in blood during the acute stress conditions in all the groups after single dose intervention at baseline (0 Week) and at 12 weeks of treatment. The magnitude of change at each of these visits was calculated from each visit baseline (0 hr) and the difference between the change at 12 weeks was compared to the change at 0 week and reported as: Change at week 12 - change at week 0.', 'unitOfMeasure': 'mM', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c Following Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapagliflozin Arm:', 'description': 'dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)\n\nDapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'OG001', 'title': 'Exenatide Extended Release Arm:', 'description': 'subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo\n\nExenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'OG002', 'title': 'Placebo Arm:', 'description': 'dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)\n\nPlacebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'OG003', 'title': 'Exenatide Extended Release & Dapagliflozin Arm:', 'description': 'Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg\n\nExenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks\n\nDapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '0.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Hemoglobin A1c (HbA1c) was measured in basal conditions in all the groups at week 0 and week 12 of treatment. The change in HbA1c from baseline at 12 weeks is calculated as: HbA1c at week 12 - HbA1c at week 0.', 'unitOfMeasure': 'Percent of Hemoglobin (%)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Urinary Beta-hydroxybutyrate (BHB) After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm:', 'description': 'dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)\n\nPlacebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'OG001', 'title': 'Dapagliflozin Arm:', 'description': 'dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)\n\nDapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'OG002', 'title': 'Exenatide Extended Release Arm:', 'description': 'subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo\n\nExenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'OG003', 'title': 'Exenatide Extended Release & Dapagliflozin Arm:', 'description': 'Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg\n\nExenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks\n\nDapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '0.6', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '0.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Beta-hydroxybutyrate (BHB) was measured in urine during the acute stress conditions in all the groups after single dose intervention at baseline (0 Week) and at 12 weeks of treatment. The magnitude of change at each of these visits was calculated from each visit baseline (0 hr) and the difference between the change at 12 weeks was compared to the change at 0 week and reported as: Change at week 12 - change at week 0.', 'unitOfMeasure': 'mM', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Glucagon', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm:', 'description': 'dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)\n\nPlacebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'OG001', 'title': 'Dapagliflozin Arm:', 'description': 'dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)\n\nDapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'OG002', 'title': 'Exenatide Extended Release Arm:', 'description': 'subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo\n\nExenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'OG003', 'title': 'Exenatide Extended Release & Dapagliflozin Arm:', 'description': 'Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg\n\nExenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks\n\nDapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '2', 'groupId': 'OG000'}, {'value': '16', 'spread': '10', 'groupId': 'OG001'}, {'value': '-15', 'spread': '8', 'groupId': 'OG002'}, {'value': '-10', 'spread': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'change in basal plasma glucagon after 12 weeks of dapagliflozin and Bydureon or combination of both treatments compared to baseline', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm:', 'description': 'dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)\n\nPlacebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'OG001', 'title': 'Dapagliflozin Arm:', 'description': 'dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)\n\nDapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'OG002', 'title': 'Exenatide Extended Release Arm:', 'description': 'subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo\n\nExenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'OG003', 'title': 'Exenatide Extended Release & Dapagliflozin Arm:', 'description': 'Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg\n\nExenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks\n\nDapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '-0.05', 'spread': '0.02', 'groupId': 'OG002'}, {'value': '-0.04', 'spread': '0.02', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'change in total (basal or long acting and short acting) insulin daily dose calculated as daily units/Kg body weight at 12 weeks from baseline (0 week). Long acting or basal insulin dose (in units of insulin) plus short acting (meal) insulin doses administered through the day and reported by patients in patients logs or from insulin pumps are added and divided by body weight in Kg. The reported total insulin dose/Kg represents the average of last 3-7 days before the visit.', 'unitOfMeasure': 'Units/Kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dapagliflozin Arm:', 'description': 'dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)\n\nDapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'FG001', 'title': 'Exenatide Extended Release Arm:', 'description': 'subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo\n\nExenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'FG002', 'title': 'Placebo Arm:', 'description': 'dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)\n\nPlacebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'FG003', 'title': 'Exenatide Extended Release & Dapagliflozin Arm:', 'description': 'Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg\n\nExenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks\n\nDapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Arm:', 'description': 'dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)\n\nPlacebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'BG001', 'title': 'Dapagliflozin Arm:', 'description': 'dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)\n\nDapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'BG002', 'title': 'Exenatide Extended Release Arm:', 'description': 'subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo\n\nExenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'BG003', 'title': 'Exenatide Extended Release & Dapagliflozin Arm:', 'description': 'Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg\n\nExenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks\n\nDapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '46.2', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '50.5', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '46.5', 'spread': '3.1', 'groupId': 'BG002'}, {'value': '44.1', 'spread': '2.6', 'groupId': 'BG003'}, {'value': '46.6', 'spread': '3.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '30.8', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '28.1', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '31.4', 'spread': '1.8', 'groupId': 'BG002'}, {'value': '30.7', 'spread': '1.8', 'groupId': 'BG003'}, {'value': '30.3', 'spread': '1.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '85.3', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '82.6', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '91.0', 'spread': '3.3', 'groupId': 'BG002'}, {'value': '91.0', 'spread': '6.0', 'groupId': 'BG003'}, {'value': '87.9', 'spread': '5.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '7.6', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '7.5', 'spread': '0.2', 'groupId': 'BG002'}, {'value': '7.9', 'spread': '0.2', 'groupId': 'BG003'}, {'value': '7.7', 'spread': '0.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'daily Basal Insulin Dose/Kg', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.08', 'groupId': 'BG000'}, {'value': '0.40', 'spread': '0.06', 'groupId': 'BG001'}, {'value': '0.41', 'spread': '0.05', 'groupId': 'BG002'}, {'value': '0.37', 'spread': '0.03', 'groupId': 'BG003'}, {'value': '0.40', 'spread': '0.06', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Basal insulin dose per kg body weight is calculated as number of units of long-acting (basal) insulin treatment needed per day divided by patient weight in kg.', 'unitOfMeasure': 'insulin units/kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-03', 'size': 787545, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-01T13:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-03', 'studyFirstSubmitDate': '2016-11-09', 'resultsFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2016-11-09', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-03', 'studyFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Beta-hydroxybutyrate Levels in Blood', 'timeFrame': '12 weeks', 'description': 'Beta-hydroxybutyrate (BHB) was measured in blood during the acute stress conditions in all the groups after single dose intervention at baseline (0 Week) and at 12 weeks of treatment. The magnitude of change at each of these visits was calculated from each visit baseline (0 hr) and the difference between the change at 12 weeks was compared to the change at 0 week and reported as: Change at week 12 - change at week 0.'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c Following Treatment', 'timeFrame': '12 weeks', 'description': 'Hemoglobin A1c (HbA1c) was measured in basal conditions in all the groups at week 0 and week 12 of treatment. The change in HbA1c from baseline at 12 weeks is calculated as: HbA1c at week 12 - HbA1c at week 0.'}, {'measure': 'Change in Urinary Beta-hydroxybutyrate (BHB) After 12 Weeks of Treatment', 'timeFrame': '12 weeks', 'description': 'Beta-hydroxybutyrate (BHB) was measured in urine during the acute stress conditions in all the groups after single dose intervention at baseline (0 Week) and at 12 weeks of treatment. The magnitude of change at each of these visits was calculated from each visit baseline (0 hr) and the difference between the change at 12 weeks was compared to the change at 0 week and reported as: Change at week 12 - change at week 0.'}, {'measure': 'Change in Plasma Glucagon', 'timeFrame': '12 weeks', 'description': 'change in basal plasma glucagon after 12 weeks of dapagliflozin and Bydureon or combination of both treatments compared to baseline'}, {'measure': 'Change in Total Insulin Dose', 'timeFrame': '12 weeks', 'description': 'change in total (basal or long acting and short acting) insulin daily dose calculated as daily units/Kg body weight at 12 weeks from baseline (0 week). Long acting or basal insulin dose (in units of insulin) plus short acting (meal) insulin doses administered through the day and reported by patients in patients logs or from insulin pumps are added and divided by body weight in Kg. The reported total insulin dose/Kg represents the average of last 3-7 days before the visit.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dapagliflozin', 'Ketogenesis', 'Type 1 Diabetes', 'DKA', 'ketones', 'exenatide/Bydureon'], 'conditions': ['Evaluate Ketogenic Stress']}, 'descriptionModule': {'briefSummary': 'The study investigations include evaluation of the acute effects of a single dose of dapagliflozin (10mg), exenatide (5µg), a combination of exenatide and dapagliflozin or placebo under insulinopenic condition and the long term effect under basal conditions before and after 12 weeks treatment with dapagliflozin, Exenatide extended release, a combination of Exenatide extended release and dapagliflozin or placebo on ketogenesis, glucagon and lipolysis.', 'detailedDescription': 'The study investigations include evaluation of the acute effects of a single dose of dapagliflozin (10mg), exenatide (5µg), a combination of exenatide and dapagliflozin or placebo under insulinopenic condition and the long term effect under basal conditions before and after 12 weeks treatment with dapagliflozin, Exenatide extended release, a combination of Exenatide extended release and dapagliflozin or placebo on ketogenesis, glucagon and lipolysis.\n\nIn the acute effects study, qualified patients will come fasting to the research center. Review of study procedures and vitals will be performed. Insulin infusion (pump) will be stopped and basal blood, urine and adipose tissue biopsy samples will be obtained. Placebos, exenatide (5µg) or dapagliflozin (10mg) (with appropriate placebos) or combination of exenatide and dapagliflozin will be administered, according to a randomized fashion, and blood samples will be collected every 30 min for up to 8 hours after starting the treatment. Urine will be collected every hour up to 8 hours and a second adipose tissue biopsy will be collected at 6 hours after the start of the treatment. Additional blood samples will be collected at 1, 2, 4 and 6 and 8 hour marks for MNC isolation. Plasma and mononuclear cell (MNC) fractions will be prepared from the blood samples. The patient will then come back at the 24 hour mark for a fasting blood and urine collection. The long term study will then commence. Exenatide extended release or dapagliflozin (along with appropriate placebos) or a combination of both drugs will be started and continued for 12 weeks according to original randomization of day 0. In the long term study, dapagliflozin (or the appropriate placebo) will be started at 5mg dose and will be titrated to 10mg/day after 5 days. Fasting blood and 24hr urine samples will be collected at 1, 4 and 8 weeks. At 12 weeks, the 2nd acute effects testing study will be repeated as described above.\n\nMeasurements of beta-hydroxybutyrate, acetoacetic acid, glucose, FFA and glucagon, will be measured from all blood samples collected. HSL, GLP-1, glycerol, electrolytes, serum bicarbonate, cortisol and catecholamines will be measured at 0, 60, 120, 240, 360, 480 min and at 24hr following single dose studies at 0 and 12 weeks visits and at baseline on the 1, 4 and 8 weeks visits. Ketone bodies will be measured in all urine samples. All MNC and adipose tissue samples will be tested for HSL and SGLT2 expression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 1 Diabetes for at least 1 year on continuous subcutaneous insulin infusion (CSII; also known as insulin pump)\n* HbA1c of 7-10% (inclusive)\n* Ages 18-65 years (inclusive of ages 18 and 65)\n* BMI 20-30 kg/m2\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Inability or refusal to comply with protocol\n* Use of GLP-1 Receptor Agonists in the last 3 months or DPP-IV and SGLT-2 inhibitors therapy in the last 1 month.\n* Risk for pancreatitis (e.g., history of gallstones, alcohol abuse, and hypertriglyceridemia)\n* History of pancreatitis and or chronic pancreatitis\n* Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) or stroke in the previous 3 months.\n* Congestive Heart Failure class III or IV or tachyarrhythmia.\n* Hepatic disease: Severe hepatic insufficiency and/or significant abnormal liver function defined as:\n\n 1. Aspartate aminotransferase (AST) \\>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \\>3x ULN\n 2. Total bilirubin \\>2.0 mg/dL (34.2 µmol/L)\n 3. Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody\n 4. Liver function tests more than 3 times the upper limit of normal\n* Renal impairment (e.g., serum creatinine levels ≥1.4 mg/dL for women, or eGFR \\<60 mL/min/1.73 m2) or history of unstable or rapidly progressing renal disease or end stage renal disease.\n* History of unexplained microscopic or gross hematuria, or microscopic hematuria at visit 1, confirmed by a follow-up sample at next scheduled visit.\n* HIV positive\n* History of gastroparesis\n* History of medullary thyroid carcinoma or MEN 2 syndrome\n* History of recurring UTI\n* Uncontrolled thyroid disease (documented normal TSH), Cushing's syndrome, congenital adrenal hyperplasia or hyperprolactinemia.\n* Prior history of a malignant disease requiring chemotherapy or patients with a prior history of bladder cancer regardless of treatment\n* Alcoholism or drug addiction.\n* Hypertriglyceridemia (\\>400 mg/dl).\n* Any other life-threatening, non-cardiac disease\n* Uncontrolled hypertension (BP \\> 160/95 mm of Hg)\n* Patients with hypotension or at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics or recently donated \\>500ml of blood should have careful monitoring of their volume status\n* Pregnant or breastfeeding patients or patient not willing to use two barrier method contraception during study period (unless sterilized or have an IUD)\n* Use of hormonal medications, 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\n* Presence of hypersensitivity to dapagliflozin or other SGLT2 inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions\n* Known hypersensitivity or contraindications to use GLP1 receptor agonists (exenatide, liraglutide)\n* Known hypersensitivity to heparin/ IV catheter equipment.\n* Eating disorders (anorexia, bulimia) or gastrointestinal disorders\n* Having a history of bariatric surgery\n* Debilitating psychiatric disorder such as psychosis or neurological condition that might confound outcome variables\n* Use of an investigational agent or therapeutic regimen within 30 days of study\n* Participation in any other concurrent clinical trial"}, 'identificationModule': {'nctId': 'NCT02962492', 'briefTitle': 'An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University at Buffalo'}, 'officialTitle': 'An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes', 'orgStudyIdInfo': {'id': '1973'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dapagliflozin Arm:', 'description': 'dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exenatide extended release Arm:', 'description': 'subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo', 'interventionNames': ['Drug: Exenatide/Exenatide extended release']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm:', 'description': 'dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exenatide extended release & dapagliflozin Arm:', 'description': 'Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg', 'interventionNames': ['Drug: Exenatide/Exenatide extended release', 'Drug: Dapagliflozin']}], 'interventions': [{'name': 'Exenatide/Exenatide extended release', 'type': 'DRUG', 'otherNames': ['Bydureon'], 'description': 'Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks', 'armGroupLabels': ['Exenatide extended release & dapagliflozin Arm:', 'Exenatide extended release Arm:']}, {'name': 'Dapagliflozin', 'type': 'DRUG', 'otherNames': ['Farxiga'], 'description': 'Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks', 'armGroupLabels': ['Dapagliflozin Arm:', 'Exenatide extended release & dapagliflozin Arm:']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo for both active drugs'], 'description': 'Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks', 'armGroupLabels': ['Placebo Arm:']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14221', 'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'facility': 'Diabetes and Endocrinology Research Center of WNY', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'SUNY Distinguished Professor', 'investigatorFullName': 'Paresh Dandona', 'investigatorAffiliation': 'University at Buffalo'}}}}