Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-02-08 @ 9:06 AM
Study NCT ID:
NCT02367066
Status:
COMPLETED
Last Update Posted:
2016-06-23
First Post:
2015-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Dr. Stanko Skrtic, MD, PhD', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet', 'otherNumAtRisk': 20, 'otherNumAffected': 5, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet', 'otherNumAtRisk': 20, 'otherNumAffected': 6, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel puncture site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel puncture site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.94', 'ciLowerLimit': '0.90', 'ciUpperLimit': '0.98', 'pValueComment': '1-sided', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.02', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9', 'description': 'MMTT=Mixed Meal Tolerance Test AUC=Area Under Curve', 'unitOfMeasure': 'h*nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Endpoint MMTT C_max for Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '0.93', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.96', 'ciLowerLimit': '0.92', 'ciUpperLimit': '0.99', 'pValueComment': '1-sided', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma C-Peptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '1.05', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.99', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.03', 'pValueComment': '1-sided', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9', 'description': 'GGI=Glucose and GLP1 infusion AUC=Area Under Curve', 'unitOfMeasure': 'h*pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '1.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.92', 'ciLowerLimit': '0.85', 'ciUpperLimit': '0.99', 'pValueComment': '1-sided', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9', 'unitOfMeasure': 'h*mU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline MMTT AUC(0-4h) for Plasma Glucagon', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '1.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.06', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.13', 'pValueComment': '1-sided', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9', 'unitOfMeasure': 'h*pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma C-Peptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.93', 'ciLowerLimit': '0.89', 'ciUpperLimit': '0.98', 'pValueComment': '1-sided', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9', 'unitOfMeasure': 'h*pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '1.35', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9', 'unitOfMeasure': 'h*mU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '1.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS MEan Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.00', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.06', 'pValueComment': '1-sided', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9', 'unitOfMeasure': 'h*mU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Glucagon', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '1.06', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9', 'unitOfMeasure': 'h*mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Glucagon', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '1.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.02', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.04', 'pValueComment': '1-sided', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.01', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9', 'unitOfMeasure': 'h*mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint Fasting Beta-cell Responsiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.01', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.03', 'pValueComment': '2-sided', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.01', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9', 'unitOfMeasure': '10^-9*(L/kg)*min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'SECONDARY', 'title': 'Fasting Insulin at Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '11.70', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '11.40', 'spread': '1.48', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 3 and Day 9', 'unitOfMeasure': 'UIU/ML', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma AZD1981 Concentration at Steady-State, C_ss,Max', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMTT', 'description': 'MMTT (Mixed Meal Tolerance Test)'}, {'id': 'OG001', 'title': 'GGI (Graded Glucose and GLP1 Infusion)', 'description': 'GGI (Graded glucose and GLP1 infusion)'}], 'classes': [{'categories': [{'measurements': [{'value': '2507', 'spread': '71.09', 'groupId': 'OG000'}, {'value': '3662', 'spread': '86.90', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 2,3,8,9', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Plasma AZD1081 Concentration, t_ss,Max', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMTT', 'description': 'MMTT (Mixed Meal Tolerance Test)'}, {'id': 'OG001', 'title': 'GGI (Graded Glucose and GLP1 Infusion)', 'description': 'GGI (Graded Glucose and GLP1 infusion)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 2,3,8,9', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.'}, {'type': 'SECONDARY', 'title': 'Plasma AZD1981 AUC(0-1h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMTT', 'description': 'MMTT (Mixed Meal Tolerance Test)'}, {'id': 'OG001', 'title': 'GGI (Graded Glucose and GLP1 Infusion)', 'description': 'GGI (Graded Glucose and GLP1 Infusion)'}], 'classes': [{'categories': [{'measurements': [{'value': '701.30', 'spread': '122.30', 'groupId': 'OG000'}, {'value': '2061', 'spread': '74.66', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 2,3,8,9', 'unitOfMeasure': 'h*nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.'}, {'type': 'SECONDARY', 'title': 'Plasma AZD1981 AUC(0-2h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMTT', 'description': 'Mixed Meal Tolerance Test (MMTT)'}, {'id': 'OG001', 'title': 'GGI (Graded Glucose and GLP1 Infusion)', 'description': 'GGI (Graded Glucose and GLP1 Infusion)'}], 'classes': [{'categories': [{'measurements': [{'value': '2071', 'spread': '97.56', 'groupId': 'OG000'}, {'value': '5016', 'spread': '75.91', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 2,3,8,9', 'unitOfMeasure': 'h*nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.'}, {'type': 'SECONDARY', 'title': 'Minimum Plasma AZD1981 Concentration at Steady-State, C_ss,Min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMTT', 'description': 'MMTT (Mixed Meal Tolerance Test)'}, {'id': 'OG001', 'title': 'GGI (Graded Glucose and GLP1 Infusion)', 'description': 'GGI (Graded Glucose and GLP1 Infusion)'}], 'classes': [{'categories': [{'measurements': [{'value': '202.40', 'spread': '39.12', 'groupId': 'OG000'}, {'value': '376.20', 'spread': '83.28', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 2,3,8,9', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.'}, {'type': 'SECONDARY', 'title': 'Plasma AZD1981 AUC(1-2h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMTT', 'description': 'MMTT (Mixed Meal Tolerance Test)'}, {'id': 'OG001', 'title': 'GGI (Graded Glucose and GLP1 Infusion)', 'description': 'GGI (Graded Glucose and GLP1 Infusion)'}], 'classes': [{'categories': [{'measurements': [{'value': '1344', 'spread': '88.76', 'groupId': 'OG000'}, {'value': '2936', 'spread': '78.72', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 2,3,8,9', 'unitOfMeasure': 'h*nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.'}, {'type': 'SECONDARY', 'title': 'Plasma Paracetamol Maximum Concentration, C_max', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '8074', 'spread': '37.32', 'groupId': 'OG000'}, {'value': '7899', 'spread': '30.51', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 3,9', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Plasma Paracetamol Concentration, t_max', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '3.50', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '4.00'}, {'value': '3.50', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '4.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 3,9', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'SECONDARY', 'title': 'Plasma Paracetamol AUC(0-t)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '19730', 'spread': '46.64', 'groupId': 'OG000'}, {'value': '18850', 'spread': '26.38', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 3,9', 'unitOfMeasure': 'h*ng/ML', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma C-Peptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9', 'unitOfMeasure': 'h*pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint GGI AUC(0-24h) for Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD1981', 'description': 'AZD1981, oral tablet'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo, oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '1.08', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9', 'unitOfMeasure': 'h*mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.'}, {'type': 'SECONDARY', 'title': 'Plasma AZD1981 AUC(0-4h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMTT', 'description': 'MMTT (Mixed Meal Tolerance Test)'}, {'id': 'OG001', 'title': 'GGI (Graded Glucose and GLP1 Infusion)', 'description': 'GGI (Graded Glucose and GLP1 Infusion)'}], 'classes': [{'categories': [{'measurements': [{'value': '5793', 'spread': '53.96', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'PK not measured for this time interval', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 2,3,8,9', 'unitOfMeasure': 'h*nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.'}, {'type': 'SECONDARY', 'title': 'Plasma AZD1981 AUC(0-12h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMTT', 'description': 'MMTT (Mixed Meal Tolerance Test)'}, {'id': 'OG001', 'title': 'GGI (Graded Glucose and GLP1 Infusion)', 'description': 'GGI (Graded Glucose and GLP1 Infusion)'}], 'classes': [{'categories': [{'measurements': [{'value': '12460', 'spread': '36.79', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'PK not measured for this time interval', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 2,3,8,9', 'unitOfMeasure': 'h*nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.'}, {'type': 'SECONDARY', 'title': 'Plasma AZD1981 AUC(0-24h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMTT', 'description': 'MMTT (Mixed Meal Tolerance Test)'}, {'id': 'OG001', 'title': 'GGI (Graded Glucose and GLP1 Infusion)', 'description': 'GGI (Graded Glucose and GLP1 Infusion)'}], 'classes': [{'categories': [{'measurements': [{'value': '24930', 'spread': '36.79', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'PK not measured for this time interval', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 2,3,8,9', 'unitOfMeasure': 'h*nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.'}, {'type': 'SECONDARY', 'title': 'Apparent Oral Plasma AZD1981 at Steady-State, CL_ss/F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMTT', 'description': 'MMTT (Mixed Meal Tolerance Test)'}, {'id': 'OG001', 'title': 'GGI (Graded Glucose and GLP1 Infusion)', 'description': 'GGI (Graded Glucose and GLP1 Infusion)'}], 'classes': [{'categories': [{'measurements': [{'value': '21.94', 'spread': '8.19', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'PK not measured for this time interval', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 2,3,8,9', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD1981-Placebo', 'description': 'Sequence AZD1981-Placebo'}, {'id': 'FG001', 'title': 'Placebo-AZD1981', 'description': 'Sequence Placebo-AZD1981'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Male or female T2DM patients of non-childbearing potential aged \\>=18 with 7.5\\<=HbA1c\\<=11%, 19\\<BMI\\<38 kg/m2, fasting plasma glucose in range 3-14 mmol/L and on Metformin as the only anti-diabetic treatment for the last 3 months', 'preAssignmentDetails': '30 patients were enrolled in the study. 10 of these were screen failures, leaving 20 patients who started the started the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD1981-Placebo', 'description': 'Sequence AZD1981-Placebo'}, {'id': 'BG001', 'title': 'Placebo-AZD1981', 'description': 'Sequence Placebo-AZD1981'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.10', 'spread': '9.10', 'groupId': 'BG000'}, {'value': '54.80', 'spread': '6.80', 'groupId': 'BG001'}, {'value': '54.00', 'spread': '7.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '87.28', 'spread': '18.95', 'groupId': 'BG000'}, {'value': '87.59', 'spread': '20.36', 'groupId': 'BG001'}, {'value': '87.44', 'spread': '19.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '166.80', 'spread': '10.70', 'groupId': 'BG000'}, {'value': '164.90', 'spread': '12.59', 'groupId': 'BG001'}, {'value': '165.80', 'spread': '11.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '31.13', 'spread': '3.58', 'groupId': 'BG000'}, {'value': '32.13', 'spread': '5.37', 'groupId': 'BG001'}, {'value': '31.63', 'spread': '4.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'T2DM disease duration', 'classes': [{'categories': [{'measurements': [{'value': '10.30', 'spread': '4.24', 'groupId': 'BG000'}, {'value': '8.60', 'spread': '5.02', 'groupId': 'BG001'}, {'value': '9.50', 'spread': '4.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Current Metformin Daily Dose', 'classes': [{'categories': [{'measurements': [{'value': '1765.00', 'spread': '473.78', 'groupId': 'BG000'}, {'value': '1895.00', 'spread': '390.48', 'groupId': 'BG001'}, {'value': '1830.00', 'spread': '427.78', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '9.50', 'spread': '1.24', 'groupId': 'BG000'}, {'value': '9.30', 'spread': '0.88', 'groupId': 'BG001'}, {'value': '9.40', 'spread': '1.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Percentage of glycosylated hemoglobin, DCCT', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-17', 'studyFirstSubmitDate': '2015-02-13', 'resultsFirstSubmitDate': '2016-03-22', 'studyFirstSubmitQcDate': '2015-02-19', 'lastUpdatePostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-17', 'studyFirstPostDateStruct': {'date': '2015-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9', 'description': 'MMTT=Mixed Meal Tolerance Test AUC=Area Under Curve'}, {'measure': 'Change From Baseline to Endpoint MMTT C_max for Plasma Glucose', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9'}, {'measure': 'Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma C-Peptide', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9', 'description': 'GGI=Glucose and GLP1 infusion AUC=Area Under Curve'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Insulin', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9'}, {'measure': 'Change From Baseline MMTT AUC(0-4h) for Plasma Glucagon', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9'}, {'measure': 'Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma C-Peptide', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9'}, {'measure': 'Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Insulin', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9'}, {'measure': 'Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Insulin', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9'}, {'measure': 'Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Glucagon', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9'}, {'measure': 'Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Glucagon', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9'}, {'measure': 'Change From Baseline to Endpoint Fasting Beta-cell Responsiveness', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9'}, {'measure': 'Fasting Insulin at Endpoint', 'timeFrame': 'Day 3 and Day 9'}, {'measure': 'Maximum Plasma AZD1981 Concentration at Steady-State, C_ss,Max', 'timeFrame': 'Days 2,3,8,9'}, {'measure': 'Time of Maximum Plasma AZD1081 Concentration, t_ss,Max', 'timeFrame': 'Days 2,3,8,9'}, {'measure': 'Plasma AZD1981 AUC(0-1h)', 'timeFrame': 'Days 2,3,8,9'}, {'measure': 'Plasma AZD1981 AUC(0-2h)', 'timeFrame': 'Days 2,3,8,9'}, {'measure': 'Minimum Plasma AZD1981 Concentration at Steady-State, C_ss,Min', 'timeFrame': 'Days 2,3,8,9'}, {'measure': 'Plasma AZD1981 AUC(1-2h)', 'timeFrame': 'Days 2,3,8,9'}, {'measure': 'Plasma Paracetamol Maximum Concentration, C_max', 'timeFrame': 'Days 3,9'}, {'measure': 'Time of Maximum Plasma Paracetamol Concentration, t_max', 'timeFrame': 'Days 3,9'}, {'measure': 'Plasma Paracetamol AUC(0-t)', 'timeFrame': 'Days 3,9'}, {'measure': 'Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma C-Peptide', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9'}, {'measure': 'Change From Baseline to Endpoint GGI AUC(0-24h) for Plasma Glucose', 'timeFrame': 'Day -1 to Day 3 and Day 6 to Day 9'}, {'measure': 'Plasma AZD1981 AUC(0-4h)', 'timeFrame': 'Days 2,3,8,9'}, {'measure': 'Plasma AZD1981 AUC(0-12h)', 'timeFrame': 'Days 2,3,8,9'}, {'measure': 'Plasma AZD1981 AUC(0-24h)', 'timeFrame': 'Days 2,3,8,9'}, {'measure': 'Apparent Oral Plasma AZD1981 at Steady-State, CL_ss/F', 'timeFrame': 'Days 2,3,8,9'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['patients', 'glycaemic control on metformin'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '30557325', 'type': 'DERIVED', 'citation': 'Skrtic S, Tyrberg B, Broberg M, Ericsson H, Schnecke V, Kjaer M, Hompesch M, Andersson EM, Ryberg E, Aivazidis A, Wennberg Huldt C, Lofgren L, Morrow L, Parkinson J, Ryden-Bergsten T, Watkins E, Sorhede Winzell M. Exploring the insulin secretory properties of the PGD2-GPR44/DP2 axis in vitro and in a randomized phase-1 trial of type 2 diabetes patients. PLoS One. 2018 Dec 17;13(12):e0208998. doi: 10.1371/journal.pone.0208998. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'A study to assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus', 'detailedDescription': 'A Single Centre, Double-blind, Randomised, Placebo-controlled, Cross-over Phase I Study to Assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Provision of informed consent\n* Male or female of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/tubal ligation) aged ≥18.\n* Patients with HbA1c ≥7.5 but ≤11% at enrolment visit (Visit 1)\n* ody mass index \\>19 to \\<38 kg/m2\n* he fasting plasma glucose should be in the range of 3-14 mmol/L (54-252 mg/dL, nclusive) on the morning of Visit 1.\n* Clinical diagnosis of type 2 diabetes mellitus\n* Metformin as only anti-diabetic treatment, at least for the last 3 months\n\nExclusion Criteria:\n\n* History or sign of any clinically significant disease or disorder which, in the opinion f the investigator, may either put the subject at risk because of participation in the sudy, or influence the results or the subject's ability to participate in the study\n* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory results \\>3x upper level of normal range (ULN) Clinical diagnosis of Type 1 diabetes mellitus and/or history of diabetic ketoacidosis or positive Glutamic Acid Decarboxylase Autoantibodies test (GAD antibodies test).\n* Patients treated with single Insulin therapy within the last 3 months"}, 'identificationModule': {'nctId': 'NCT02367066', 'briefTitle': 'A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Single Centre, Double-blind, Randomised, Placebo-controlled, Cross-over Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX After Administration of Repeated Doses for 3 Days in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'D6420C00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AR-C165395XX + placebo', 'description': '1st period AR-C165395XX 2nd period placebo', 'interventionNames': ['Drug: AR-C165395XX']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + AR-C165395XX', 'description': '1st period Placebo for AR-C165395XX 2nd period AR-C165395XX', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'AR-C165395XX', 'type': 'DRUG', 'description': 'Oral dose of AR-C165395XX (tablets)', 'armGroupLabels': ['AR-C165395XX + placebo']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Oral dose of placebo for AR-C165395XX (tablets)', 'armGroupLabels': ['Placebo + AR-C165395XX']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}], 'overallOfficials': [{'name': 'Liliana Uribe-Bruce, MD, MCI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Profil Institute for Clinical Research, Inc.'}, {'name': 'Stanko Skrtic, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D Mölndal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}