Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-02-03 @ 6:38 AM
Study NCT ID:
NCT02182895
Status:
COMPLETED
Last Update Posted:
2017-06-23
First Post:
2014-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'C502994', 'term': 'saxagliptin'}, {'id': 'D054873', 'term': 'Dipeptidyl-Peptidase IV Inhibitors'}], 'ancestors': [{'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rgarg@partners.org', 'phone': '617-732-5584', 'title': 'Dr. Rajesh Garg, MD', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the study period.', 'eventGroups': [{'id': 'EG000', 'title': 'Saxagliptin Group', 'description': 'saxagliptin 2.5-5 mg daily', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 2, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Therapy Group', 'description': 'No saxagliptin treatment', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Failure to control hyperglucycemia', 'notes': 'Study drug stopped', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Daily Blood Glucose Levels During Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin Group', 'description': 'saxagliptin 2.5-5 mg daily'}, {'id': 'OG001', 'title': 'Standard Therapy Group', 'description': 'No saxagliptin treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '154.8', 'spread': '28.2', 'groupId': 'OG000'}, {'value': '156.0', 'spread': '32.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hospital days 2-5', 'description': 'mean of average daily blood blood glucose for each patient day', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Inpatients with diabetes'}, {'type': 'SECONDARY', 'title': 'Percentage of Blood Glucose Readings in 70-140 mg/dL Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin Group', 'description': 'saxagliptin 2.5-5 mg daily'}, {'id': 'OG001', 'title': 'Standard Therapy Group', 'description': 'No saxagliptin treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 2 to 5', 'description': 'Percentage of BG readings in the desired range of 70-140 mg/dl out of all avaialble BG readings.', 'unitOfMeasure': '% of blood glucose readings', 'reportingStatus': 'POSTED', 'populationDescription': 'completed subjects'}, {'type': 'SECONDARY', 'title': 'Dose of Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin Group', 'description': 'saxagliptin 2.5-5 mg daily'}, {'id': 'OG001', 'title': 'Standard Therapy Group', 'description': 'No saxagliptin treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '12.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 2 to 5', 'description': 'Average daily amount of insulin used', 'unitOfMeasure': 'Units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'completed subjects'}, {'type': 'SECONDARY', 'title': 'Incidence of Hypoglycemia (BG <70 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin Group', 'description': 'saxagliptin 2.5-5 mg daily'}, {'id': 'OG001', 'title': 'Standard Therapy Group', 'description': 'No saxagliptin treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 2 to 5', 'description': 'Number of BG readings \\<70 mg/dL in each group', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED', 'populationDescription': 'completed'}, {'type': 'SECONDARY', 'title': 'Incidence of Hyperglycemia (Blood Glucose >200 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin Group', 'description': 'saxagliptin 2.5-5 mg daily'}, {'id': 'OG001', 'title': 'Standard Therapy Group', 'description': 'No saxagliptin treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 2 to 5', 'description': 'Proportion of BG readings in the severe hyperglycemic range.', 'unitOfMeasure': '% of blood glucose readings >200', 'reportingStatus': 'POSTED', 'populationDescription': 'completed'}, {'type': 'SECONDARY', 'title': 'Variability in Glucose Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin Group', 'description': 'saxagliptin 2.5-5 mg daily'}, {'id': 'OG001', 'title': 'Standard Therapy Group', 'description': 'No saxagliptin treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '2.72', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '3.93', 'spread': '2.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 2 to 5', 'description': 'Mean amplitude of glycemic excursions', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who allowed a CGMS.'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin Group', 'description': 'saxagliptin 2.5-5 mg daily'}, {'id': 'OG001', 'title': 'Standard Therapy Group', 'description': 'No saxagliptin treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Admission to discharge, an expected average of 5 days', 'description': 'Number of days in hospital', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'completed'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Saxagliptin Group', 'description': 'saxagliptin 2.5-5 mg daily'}, {'id': 'OG001', 'title': 'Standard Therapy Group', 'description': 'No saxagliptin treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '12', 'groupId': 'OG000'}, {'value': '75', 'spread': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the time of discharge or Day 5', 'description': 'Diabetes Treatment Satisfaction Questionnaire - InPatient (DTSQ-IP). This questionnaire had 14 items that were scored on a scale of 0 to 6. Total score for each subjects could range from 0-84. Higher score means better satisfaction.', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Saxagliptin Group', 'description': 'saxagliptin 2.5-5 mg daily'}, {'id': 'FG001', 'title': 'Standard Therapy Group', 'description': 'No saxagliptin treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Discharged from hospital within 24 hours', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Saxagliptin Group', 'description': 'DPP4 inhibitor therapy group will receive saxagliptin 2.5 to 5 mg daily in addition to correctional sliding scale insulin therapy before each meal and bedtime.\n\nSaxagliptin: 2.5-5 mg daily'}, {'id': 'BG001', 'title': 'Standard Therapy Group', 'description': 'Standard therapy group will receive basal-bolus insulin starting at a dose of 0.5 units/kg/day; given half as insulin glargine and half as insulin aspart. In addition, the standard therapy group will receive the correctional sliding scale insulin therapy before each meal and bedtime.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '10', 'groupId': 'BG000'}, {'value': '67', 'spread': '10', 'groupId': 'BG001'}, {'value': '68', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'white', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '32.6', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '33.6', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-31', 'studyFirstSubmitDate': '2014-06-30', 'resultsFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2014-07-02', 'lastUpdatePostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-01', 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Daily Blood Glucose Levels During Hospital', 'timeFrame': 'Hospital days 2-5', 'description': 'mean of average daily blood blood glucose for each patient day'}], 'secondaryOutcomes': [{'measure': 'Percentage of Blood Glucose Readings in 70-140 mg/dL Range', 'timeFrame': 'Days 2 to 5', 'description': 'Percentage of BG readings in the desired range of 70-140 mg/dl out of all avaialble BG readings.'}, {'measure': 'Dose of Insulin', 'timeFrame': 'Days 2 to 5', 'description': 'Average daily amount of insulin used'}, {'measure': 'Incidence of Hypoglycemia (BG <70 mg/dL)', 'timeFrame': 'Days 2 to 5', 'description': 'Number of BG readings \\<70 mg/dL in each group'}, {'measure': 'Incidence of Hyperglycemia (Blood Glucose >200 mg/dL)', 'timeFrame': 'Days 2 to 5', 'description': 'Proportion of BG readings in the severe hyperglycemic range.'}, {'measure': 'Variability in Glucose Levels', 'timeFrame': 'Days 2 to 5', 'description': 'Mean amplitude of glycemic excursions'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Admission to discharge, an expected average of 5 days', 'description': 'Number of days in hospital'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'At the time of discharge or Day 5', 'description': 'Diabetes Treatment Satisfaction Questionnaire - InPatient (DTSQ-IP). This questionnaire had 14 items that were scored on a scale of 0 to 6. Total score for each subjects could range from 0-84. Higher score means better satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '28405346', 'type': 'DERIVED', 'citation': 'Garg R, Schuman B, Hurwitz S, Metzger C, Bhandari S. Safety and efficacy of saxagliptin for glycemic control in non-critically ill hospitalized patients. BMJ Open Diabetes Res Care. 2017 Mar 29;5(1):e000394. doi: 10.1136/bmjdrc-2017-000394. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to test the safety and efficacy of a drug called saxagliptin (Onglyza) for treatment of type 2 diabetes in non-critically ill hospitalized patients who have an HbA1c of 7.5 or lower, on 1 or no non-insulin agent at home, or an HbA1c ≤7.0% on ≤ 2 non-insulin agents at home.', 'detailedDescription': 'The current professional organization guidelines recommend insulin as the preferred treatment for hospitalized patients. It is recommended that most critically ill patients should receive insulin infusion therapy and non-critically ill patients should receive basal bolus insulin therapy in the hospital.\n\nThe study will test the hypothesis that treatment with saxagliptin is non-inferior to treatment with basal bolus insulin in this group of patients during their hospital stay. The study will evaluate the effect of saxagliptin, a DPP4 inhibitor, on glycemic control in non-critically ill hospitalized patients with type 2 diabetes mellitus (T2DM)\n\nThe primary outcome will be mean daily blood glucose levels during hospital days 2 to 5. The study is designed to detect a non-inferiority margin of 20% in the saxagliptin group as compared to the control group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with T2DM and HbA1C ≤7.5% on ≤1 non-insulin hypoglycemic agent or HbA1C ≤7.0% on ≤2 non-insulin hypoglycemic agents admitted to the hospital for a non-critical illness.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Admitted to or expected to require admission to ICU\n* Patients with a history of diabetic ketoacidosis or hyperosmolar state\n* HbA1c \\>7.5% at the time of admission or within 3 months before admission\n* Insulin requiring before admission\n* Unable to take oral food or medications\n* Systemic steroid use\n* Pregnancy or breastfeeding\n* Women of Child-Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after the last dose of study drug.\n* History of pancreatitis or active gallbladder disease\n* End stage renal disease on dialysis\n* Hypersensitivity to saxagliptin or another contraindication to DPP4 inhibitors\n* Subject unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT02182895', 'briefTitle': 'Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient', 'orgStudyIdInfo': {'id': '2014P001095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saxagliptin group', 'description': 'DPP4 inhibitor therapy group will receive saxagliptin 2.5 to 5 mg daily in addition to correctional sliding scale insulin therapy before each meal and bedtime.', 'interventionNames': ['Drug: Saxagliptin']}, {'type': 'NO_INTERVENTION', 'label': 'Standard therapy group', 'description': 'Standard therapy group will receive basal-bolus insulin starting at a dose of 0.5 units/kg/day; given half as insulin glargine and half as insulin aspart. In addition, the standard therapy group will receive the correctional sliding scale insulin therapy before each meal and bedtime.'}], 'interventions': [{'name': 'Saxagliptin', 'type': 'DRUG', 'otherNames': ['Onglyza', 'DPP4 inhibitor'], 'description': '2.5-5 mg daily', 'armGroupLabels': ['Saxagliptin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Rajesh K Garg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rajesh Garg, MD', 'investigatorFullName': 'Rajesh K. Garg', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}