Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-09 @ 7:04 AM
Study NCT ID:
NCT04556760
Status:
COMPLETED
Last Update Posted:
2024-07-18
First Post:
2020-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712985', 'term': 'AZD9567'}, {'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-94 79', 'title': 'Global Clinical Head', 'organization': 'AstraZeneca Clinical Study Information Center'}, 'certainAgreement': {'otherDetails': 'No unpublished information may be disclosed without prior written approval from AstraZeneca.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Screening up to Final/ end of treatment visit (Day 79).', 'description': 'Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention. The SAF was analysed according to actual treatment.\n\nThree additional arms were created to capture Adverse Events for each treatment within the cohort.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: AZD9567 72mg', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD956', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 4, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1: Prednisolone 40mg', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD956', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 7, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 2: AZD9567 40mg', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 2: Prednisolone 20mg', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD956', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 3: Placebo', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 3: Prednisolone 5mg', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Administration site phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Catheter site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Catheter site related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glucose Area Under the Plasma Concentration Versus Time Curve From Zero to 4 Hours Post-dose AUC(0-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}], 'classes': [{'title': 'AZD9567', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-190.0296', 'spread': '63.8805', 'groupId': 'OG000'}, {'value': '-182.7172', 'spread': '149.8600', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-57.0768', 'spread': '63.8762', 'groupId': 'OG000'}, {'value': '-40.6842', 'spread': '141.7154', 'groupId': 'OG001'}, {'value': '-184.9677', 'spread': '88.9807', 'groupId': 'OG002'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-311.8506', 'spread': '88.5443', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-132.9528', 'ciLowerLimit': '-256.5082', 'ciUpperLimit': '-9.3973', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.432', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-142.0330', 'ciLowerLimit': '-554.8722', 'ciUpperLimit': '270.8061', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.030', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-126.8829', 'ciLowerLimit': '-236.0426', 'ciUpperLimit': '-17.7233', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Days -1 (baseline), and Days 4 (Treatment period 1 and 2)', 'description': 'The change from baseline in glucose AUC(0-4) was analysed to determine the Pharmacodynamic (PD) effect of AZD9567 compared to Prednisolone following a standardised Mixed meal tolerance test (MMTT).\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'minute*millimole/liter (min*mmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Mean Glucose Level as Determined Via the Continuous Glucose Monitoring (CGM) System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}], 'classes': [{'title': 'AZD9567', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.5730', 'spread': '0.3114', 'groupId': 'OG000'}, {'value': '7.7870', 'spread': '0.2517', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.0797', 'spread': '0.3150', 'groupId': 'OG000'}, {'value': '8.8969', 'spread': '0.2494', 'groupId': 'OG001'}, {'value': '7.4238', 'spread': '0.2889', 'groupId': 'OG002'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.2638', 'spread': '0.2888', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5067', 'ciLowerLimit': '-2.0820', 'ciUpperLimit': '-0.9314', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1099', 'ciLowerLimit': '-1.7257', 'ciUpperLimit': '-0.4941', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.547', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.1601', 'ciLowerLimit': '-0.6930', 'ciUpperLimit': '0.3729', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '48 to 72 hours', 'description': 'The mean glucose levels in mmol/L at 48-72 h was analysed to determine the effect of AZD9567 on CGM compared to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'millimole/liter (mmol/L) per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Rise in Mean Glucose Levels Over 24-hour Periods From Start of IMP Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}], 'classes': [{'title': 'AZD9567 (00 to 24 hours [h])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.2071', 'spread': '0.2869', 'groupId': 'OG000'}, {'value': '0.4070', 'spread': '0.2509', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone (00 to 24 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.7086', 'spread': '0.2938', 'groupId': 'OG000'}, {'value': '1.2545', 'spread': '0.2460', 'groupId': 'OG001'}, {'value': '0.3123', 'spread': '0.1549', 'groupId': 'OG002'}]}]}, {'title': 'Placebo (00 to 24 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.0477', 'spread': '0.1547', 'groupId': 'OG002'}]}]}, {'title': 'AZD9567 (24 to 48 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8011', 'spread': '0.2978', 'groupId': 'OG000'}, {'value': '0.5428', 'spread': '0.2483', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone (24 to 48 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.6653', 'spread': '0.3044', 'groupId': 'OG000'}, {'value': '1.3206', 'spread': '0.2448', 'groupId': 'OG001'}, {'value': '-0.2415', 'spread': '0.2898', 'groupId': 'OG002'}]}]}, {'title': 'Placebo (24 to 48 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3260', 'spread': '0.2894', 'groupId': 'OG002'}]}]}, {'title': 'AZD9567 (48 to 72 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8529', 'spread': '0.3210', 'groupId': 'OG000'}, {'value': '0.0744', 'spread': '0.2714', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone (48 to 72 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.4527', 'spread': '0.3274', 'groupId': 'OG000'}, {'value': '1.2174', 'spread': '0.2664', 'groupId': 'OG001'}, {'value': '-0.2202', 'spread': '0.2229', 'groupId': 'OG002'}]}]}, {'title': 'Placebo (48 to 72 h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3500', 'spread': '0.2224', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5015', 'ciLowerLimit': '-2.2258', 'ciUpperLimit': '-0.7773', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \\[00 to 24 h\\])', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-1.8643', 'ciLowerLimit': '-2.5611', 'ciUpperLimit': '-1.1674', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \\[24 to 48 h\\])', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5998', 'ciLowerLimit': '-2.3025', 'ciUpperLimit': '-0.8971', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \\[48 to 72 h\\])', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.013', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8474', 'ciLowerLimit': '-1.4465', 'ciUpperLimit': '-0.2484', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \\[00 to 24 h\\])', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.061', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7778', 'ciLowerLimit': '-1.6022', 'ciUpperLimit': '0.0466', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \\[24 to 48 h\\])', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.003', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1430', 'ciLowerLimit': '-1.7622', 'ciUpperLimit': '-0.5238', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \\[48 to 72 h\\])', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.125', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3600', 'ciLowerLimit': '-0.8338', 'ciUpperLimit': '0.1138', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \\[00 to 24 h\\])', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.840', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0845', 'ciLowerLimit': '-0.9706', 'ciUpperLimit': '0.8016', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \\[24 to 48 h\\])', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.571', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1298', 'ciLowerLimit': '-0.6460', 'ciUpperLimit': '0.3864', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \\[48 to 72 h\\])', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 72 hours (Treatment period 1 and 2)', 'description': 'The mean glucose level in mmol/L was analysed to determine the effect of AZD9567 on CGM compared to prednisolone.\n\nFor the calculation of the rise in mean glucose levels, the baseline was the average of the values from -24 hours to first dosing on Day 1 of each period.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'mmol/L per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}], 'classes': [{'title': 'AZD9567', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.14', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-0.95', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.06', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '-1.15', 'spread': '0.20', 'groupId': 'OG002'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'spread': '0.20', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.753', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.40', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.802', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.37', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.985', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.37', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Pharmacodynamic effects (fasting glucose) of AZD9567 following a MMTT were evaluated as compared to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Insulin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}], 'classes': [{'title': 'AZD9567', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15319.3857', 'spread': '4165.9135', 'groupId': 'OG000'}, {'value': '13413.1929', 'spread': '4791.9873', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5179.3659', 'spread': '3989.2683', 'groupId': 'OG000'}, {'value': '10091.7869', 'spread': '5461.2631', 'groupId': 'OG001'}, {'value': '4915.4115', 'spread': '7049.5460', 'groupId': 'OG002'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2216.5532', 'spread': '7049.0432', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20498.7', 'ciLowerLimit': '10819.2', 'ciUpperLimit': '30178.2', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.659', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3321.4', 'ciLowerLimit': '-12975.8', 'ciUpperLimit': '19618.6', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.521', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2698.8', 'ciLowerLimit': '-14849.0', 'ciUpperLimit': '9451.3', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on insulin AUC(0-4) were assessed following MMTT compared to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'minute*picomole/liter (min*pmole/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Glucagon)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}], 'classes': [{'title': 'AZD9567', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-36.9846', 'spread': '216.5777', 'groupId': 'OG000'}, {'value': '552.0634', 'spread': '213.9300', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '965.6018', 'spread': '216.6054', 'groupId': 'OG000'}, {'value': '511.0798', 'spread': '213.5970', 'groupId': 'OG001'}, {'value': '259.9835', 'spread': '298.9801', 'groupId': 'OG002'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '361.3971', 'spread': '348.5104', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1002.5864', 'ciLowerLimit': '-1620.2150', 'ciUpperLimit': '-384.9577', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.865', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.9836', 'ciLowerLimit': '-526.6968', 'ciUpperLimit': '608.6640', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.754', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '101.4137', 'ciLowerLimit': '-628.8097', 'ciUpperLimit': '831.6370', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on glucagon AUC(0-4) were assessed following MMTT in comparison to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'min*pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Glucagon-like Peptide-1 [GLP-1])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}], 'classes': [{'title': 'AZD9567', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '615.9803', 'spread': '328.8418', 'groupId': 'OG000'}, {'value': '322.5690', 'spread': '454.2028', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1841.8853', 'spread': '328.8877', 'groupId': 'OG000'}, {'value': '789.5492', 'spread': '450.2548', 'groupId': 'OG001'}, {'value': '575.6726', 'spread': '318.1088', 'groupId': 'OG002'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '200.3565', 'spread': '317.6326', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1225.9050', 'ciLowerLimit': '-2007.2241', 'ciUpperLimit': '-444.5859', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.313', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-466.9802', 'ciLowerLimit': '-1521.5088', 'ciUpperLimit': '587.5485', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.404', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-375.3161', 'ciLowerLimit': '-1433.6265', 'ciUpperLimit': '682.9943', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on GLP-1 AUC(0-4) were assessed following MMTT in comparison to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'min*pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Glucose-dependent Insulin Releasing Polypeptide [GIP])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}], 'classes': [{'title': 'AZD9567', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3658.9885', 'spread': '584.5079', 'groupId': 'OG000'}, {'value': '3842.9307', 'spread': '1303.1553', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3293.3563', 'spread': '596.7472', 'groupId': 'OG000'}, {'value': '3654.6947', 'spread': '1289.5516', 'groupId': 'OG001'}, {'value': '3271.5164', 'spread': '823.9967', 'groupId': 'OG002'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2210.0670', 'spread': '827.7335', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.608', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '365.6323', 'ciLowerLimit': '-1097.7973', 'ciUpperLimit': '1829.0618', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.897', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '188.2360', 'ciLowerLimit': '-3214.3323', 'ciUpperLimit': '3590.8043', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.381', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-1061.4494', 'ciLowerLimit': '-3588.2233', 'ciUpperLimit': '1465.3244', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on GIP AUC(0-4) were assessed following MMTT in comparison to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'min*pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AUC(0-4) on C-peptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg 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'categories': [{'measurements': [{'value': '24.9094', 'spread': '13.4282', 'groupId': 'OG000'}, {'value': '55.6606', 'spread': '22.6155', 'groupId': 'OG001'}, {'value': '24.7245', 'spread': '22.2183', 'groupId': 'OG002'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7002', 'spread': '22.0424', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '60.4211', 'ciLowerLimit': '29.4904', 'ciUpperLimit': '91.3518', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.432', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '26.4529', 'ciLowerLimit': '-44.9414', 'ciUpperLimit': '97.8471', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.282', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-24.0243', 'ciLowerLimit': '-74.0731', 'ciUpperLimit': '26.0245', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on C-peptide AUC(0-4) were assessed through a MMTT in comparison to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'minute*nanomole/L (min*nmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ratio of Insulin to Glucose Level Between 10 and 0 Minutes (ΔI10/ΔG10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}], 'classes': [{'title': 'AZD9567', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.5249', 'spread': '0.6632', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Convergence was not met thus no data are available.', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0774', 'spread': '0.6674', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Convergence was not met thus no data are available.', 'groupId': 'OG001'}, {'value': '-0.8153', 'spread': '0.8305', 'groupId': 'OG002'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3532', 'spread': '0.6893', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.531', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6023', 'ciLowerLimit': '-2.5463', 'ciUpperLimit': '1.3416', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.682', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4621', 'ciLowerLimit': '-2.0933', 'ciUpperLimit': '3.0176', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on ΔI10/ΔG10 of beta cell function from the MMTT compared to Prednisolone was evaluated.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ratio of Insulin to Glucose Level Between 30 and 0 Minutes [ΔI30/ΔG30])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}], 'classes': [{'title': 'AZD9567', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1203', 'spread': '0.0726', 'groupId': 'OG000'}, {'value': '0.1824', 'spread': '0.0773', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0530', 'spread': '0.0755', 'groupId': 'OG000'}, {'value': '0.0943', 'spread': '0.1264', 'groupId': 'OG001'}, {'value': '-0.1047', 'spread': '0.0665', 'groupId': 'OG002'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0209', 'spread': '0.0599', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.526', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.0679', 'ciLowerLimit': '-0.1520', 'ciUpperLimit': '0.2866', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.569', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.0882', 'ciLowerLimit': '-0.2653', 'ciUpperLimit': '0.4416', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.166', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1257', 'ciLowerLimit': '-0.0677', 'ciUpperLimit': '0.3191', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Day -1 (Baseline), and 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{'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.0103', 'spread': '0.0092', 'groupId': 'OG000'}, {'value': '0.0026', 'spread': '0.0047', 'groupId': 'OG001'}, {'value': '-0.0033', 'spread': '0.0064', 'groupId': 'OG002'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.0024', 'spread': '0.0057', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.226', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0100', 'ciLowerLimit': '-0.0072', 'ciUpperLimit': '0.0271', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.619', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.0033', 'ciLowerLimit': '-0.0128', 'ciUpperLimit': '0.0195', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.917', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.0009', 'ciLowerLimit': '-0.0189', 'ciUpperLimit': '0.0207', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on ΔC10/ΔG10 of beta cell function from the MMTT compared to Prednisolone was evaluated.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ratio of C-peptide to Glucose Level Between 30 and 0 Minutes (ΔC30/ΔG30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone 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{'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0002', 'spread': '0.0005', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.357', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0007', 'ciLowerLimit': '-0.0008', 'ciUpperLimit': '0.0022', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.676', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0003', 'ciLowerLimit': '-0.0012', 'ciUpperLimit': '0.0017', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.096', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.0012', 'ciLowerLimit': '-0.0002', 'ciUpperLimit': '0.0026', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on ΔC30/ΔG30 of beta cell function from the MMTT compared to Prednisolone was evaluated.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24-hour Urinary Potassium Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}], 'classes': [{'title': 'AZD9567', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.92', 'spread': '3.27', 'groupId': 'OG000'}, {'value': '-6.05', 'spread': '4.30', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.19', 'spread': '3.27', 'groupId': 'OG000'}, {'value': '4.92', 'spread': '4.29', 'groupId': 'OG001'}, {'value': '-2.49', 'spread': '9.08', 'groupId': 'OG002'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.85', 'spread': '9.07', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.646', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.73', 'ciLowerLimit': '-9.40', 'ciUpperLimit': '5.95', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.110', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-10.97', 'ciLowerLimit': '-25.39', 'ciUpperLimit': '3.44', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.932', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-10.32', 'ciUpperLimit': '9.61', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'The concentration of potassium in urine was measured over 24 hours to determine the effect of AZD9567 on urinary potassium (U-K) excretion compared to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'mmol/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24-hour Urinary Sodium Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}], 'classes': [{'title': 'AZD9567', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.4', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '39.9', 'spread': '20.4', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.7', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '20.3', 'groupId': 'OG001'}, {'value': '-18.1', 'spread': '21.4', 'groupId': 'OG002'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.9', 'spread': '21.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.533', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.6', 'ciLowerLimit': '-17.4', 'ciUpperLimit': '32.7', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.311', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '22.3', 'ciLowerLimit': '-26.7', 'ciUpperLimit': '71.3', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.204', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '31.0', 'ciLowerLimit': '-21.9', 'ciUpperLimit': '83.9', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'The concentration of sodium in urine was measured over 24 hours to determine the effect of AZD9567 on urinary-sodium (U-Na) excretion compared to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'mmol/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Quantifiable Concentration (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}], 'classes': [{'categories': [{'measurements': [{'value': '34400', 'spread': '42.97', 'groupId': 'OG000'}, {'value': '18410', 'spread': '46.06', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Upto 30 hours post dose (Treatment period 1 and 2)', 'description': 'AUClast of AZD9567 following once daily dosing was evaluated.', 'unitOfMeasure': 'hour*nanomole/liter (h*nmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PKAS) consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or adverse events (AEs) considered to have an effect upon PK.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours Post-dose [AUC(0-24)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}], 'classes': [{'categories': [{'measurements': [{'value': '32920', 'spread': '41.32', 'groupId': 'OG000'}, {'value': '17790', 'spread': '44.86', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post dose', 'description': 'AUC(0-24) of AZD9567 following once daily dosing was evaluated.', 'unitOfMeasure': 'h*nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve From Zero to 6 Hours Post-dose [AUC(0-6)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}], 'classes': [{'categories': [{'measurements': [{'value': '17050', 'spread': '30.45', 'groupId': 'OG000'}, {'value': '9914', 'spread': '35.06', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 hours post dose', 'description': 'AUC(0-6) of AZD9567 following once daily dosing was evaluated.', 'unitOfMeasure': 'h*nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Drug Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}], 'classes': [{'categories': [{'measurements': [{'value': '4501', 'spread': '26.90', 'groupId': 'OG000'}, {'value': '2939', 'spread': '31.50', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Upto 30 hours post dose (Treatment period 1 and 2)', 'description': 'Cmax of AZD9567 following once daily dosing was evaluated.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Drug Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0.25', 'upperLimit': '1.50'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Upto 30 hours post dose (Treatment period 1 and 2)', 'description': 'Tmax of AZD9567 following once daily dosing was evaluated.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half-life (t½λz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}], 'classes': [{'categories': [{'measurements': [{'value': '6.99', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '6.16', 'spread': '1.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Upto 30 hours post dose (Treatment period 1 and 2)', 'description': 't½λz of AZD9567 following once daily dosing was evaluated.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.'}, {'type': 'SECONDARY', 'title': 'Apparent Total Body Clearance of Drug From Plasma After Extravascular (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}], 'classes': [{'categories': [{'measurements': [{'value': '4.766', 'spread': '1.896', 'groupId': 'OG000'}, {'value': '4.924', 'spread': '2.098', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Upto 30 hours post dose (Treatment period 1 and 2)', 'description': 'CL/F of AZD9567 following once daily dosing was evaluated.', 'unitOfMeasure': 'Liter/hour (L/h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution Following Extravascular Administration (Vz/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}], 'classes': [{'categories': [{'measurements': [{'value': '45.11', 'spread': '11.39', 'groupId': 'OG000'}, {'value': '41.75', 'spread': '14.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Upto 30 hours post dose (Treatment period 1 and 2)', 'description': 'Vz/F of AZD9567 was derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKAS consisted of all patients in the FAS with at least 1 quantifiable AZD9567 concentration and no important protocol deviations, or AEs considered to have an effect upon PK.'}, {'type': 'SECONDARY', 'title': 'Tumour Necrosis Factor Alpha (TNFα) Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}], 'classes': [{'title': 'AZD9567 (0h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21000.1', 'spread': '15413.92', 'groupId': 'OG000'}, {'value': '23525.0', 'spread': '15260.57', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone (0h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21361.5', 'spread': '18124.60', 'groupId': 'OG000'}, {'value': '12385.0', 'spread': '11835.31', 'groupId': 'OG001'}]}]}, {'title': 'AZD9567 (1h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9100.2', 'spread': '6248.93', 'groupId': 'OG000'}, {'value': '8122.5', 'spread': '5303.16', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone (1h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3581.1', 'spread': '3642.93', 'groupId': 'OG000'}, {'value': '3617.5', 'spread': '1552.62', 'groupId': 'OG001'}]}]}, {'title': 'AZD9567 (2h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8170.7', 'spread': '5053.69', 'groupId': 'OG000'}, {'value': '8098.0', 'spread': '7709.06', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone (2h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1648.2', 'spread': '1109.64', 'groupId': 'OG000'}, {'value': '1421.1', 'spread': '591.80', 'groupId': 'OG001'}]}]}, {'title': 'AZD9567 (4h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7534.6', 'spread': '4519.50', 'groupId': 'OG000'}, {'value': '8898.8', 'spread': '5249.73', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone (4h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2293.1', 'spread': '1329.60', 'groupId': 'OG000'}, {'value': '4292.0', 'spread': '3207.76', 'groupId': 'OG001'}]}]}, {'title': 'AZD9567 (8h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10674.4', 'spread': '7731.94', 'groupId': 'OG000'}, {'value': '13023.8', 'spread': '8946.33', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone (8h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4585.7', 'spread': '4453.61', 'groupId': 'OG000'}, {'value': '7247.5', 'spread': '2889.87', 'groupId': 'OG001'}]}]}, {'title': 'AZD9567 (12h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13332.5', 'spread': '10831.44', 'groupId': 'OG000'}, {'value': '14695.0', 'spread': '11422.87', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone (12h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12415.5', 'spread': '9474.44', 'groupId': 'OG000'}, {'value': '16790.0', 'spread': '8010.23', 'groupId': 'OG001'}]}]}, {'title': 'AZD9567 (24h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22136.7', 'spread': '13414.45', 'groupId': 'OG000'}, {'value': '19741.3', 'spread': '11048.74', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone (24h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23292.9', 'spread': '15548.12', 'groupId': 'OG000'}, {'value': '20920.0', 'spread': '14802.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On Days 3 (Treatment period 1 and 2)', 'description': 'Relationship between AZD9567 exposure and inhibition of LPS-stimulated TNFα release for high and low dose comparison (Cohort 1 and Cohort 2) was assessed. LPS-stimulated TNFα concentration was measured.', 'unitOfMeasure': 'nanogram/liter (ng/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Free Fatty Acids)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}], 'classes': [{'title': 'AZD9567', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-18.1304', 'spread': '1.7543', 'groupId': 'OG000'}, {'value': '-14.0582', 'spread': '3.7038', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-14.1238', 'spread': '1.7542', 'groupId': 'OG000'}, {'value': '-19.8117', 'spread': '3.7060', 'groupId': 'OG001'}, {'value': '-4.1625', 'spread': '3.7212', 'groupId': 'OG002'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.8995', 'spread': '3.7153', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.103', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.0066', 'ciLowerLimit': '-8.8880', 'ciUpperLimit': '0.8748', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.005', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '5.7535', 'ciLowerLimit': '2.6034', 'ciUpperLimit': '8.9036', 'groupDescription': 'Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.023', 'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '9.0619', 'ciLowerLimit': '1.6740', 'ciUpperLimit': '16.4499', 'groupDescription': 'Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on free fatty acids were evaluated following a MMTT compared to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'min*mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Homeostatic Model Assessment- Insulin Resistance (HOMA-IR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}], 'classes': [{'title': 'AZD9567', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4406', 'spread': '1.9875', 'groupId': 'OG000'}, {'value': '-0.1738', 'spread': '0.7576', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.7023', 'spread': '1.5896', 'groupId': 'OG000'}, {'value': '0.0721', 'spread': '0.9606', 'groupId': 'OG001'}, {'value': '-0.5662', 'spread': '0.7364', 'groupId': 'OG002'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.9280', 'spread': '0.8173', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'The HOMA-IR was calculated based on glucose and insulin measured prior to MMTT.\n\nHOMA-IR= Glucose(mmol/L) x Insulin (mU/L) / 22.5\n\nHOMA-IR score estimates the degree of insulin resistance. Higher range indicates greater insulin resistance (i.e. high diabetes risk), while lower range indicates insulin sensitivity (i.e. low diabetes risk)\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HOMA-insulin Sensitivity (HOMA-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}], 'classes': [{'title': 'AZD9567', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0134', 'spread': '0.2352', 'groupId': 'OG000'}, {'value': '-0.0360', 'spread': '0.1990', 'groupId': 'OG001'}]}]}, {'title': 'Prednisolone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0328', 'spread': '0.1400', 'groupId': 'OG000'}, {'value': '-0.0799', 'spread': '0.2077', 'groupId': 'OG001'}, {'value': '0.0750', 'spread': '0.0949', 'groupId': 'OG002'}]}]}, {'title': 'Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1468', 'spread': '0.0930', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Insulin sensitivity is a term used to indicate the responsiveness of the peripheral tissue cells to insulin, and their resultant capacity to uptake glucose out of the bloodstream.\n\nHOMA-S score estimates the degree of insulin sensitivity. HOMA-S was calculated as the reciprocal of HOMA-IR.\n\nHigher values indicates greater insulin sensitivity (i.e. low diabetes risk), while lower values indicates insulin resistance (i.e. high diabetes risk)\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consisted of all randomised patients who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: AZD9567 72mg', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG001', 'title': 'Cohort 1: Prednisolone 40mg', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'OG002', 'title': 'Cohort 2: AZD9567 40mg', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG003', 'title': 'Cohort 2: Prednisolone 20mg', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'OG004', 'title': 'Cohort 3: Placebo', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}, {'id': 'OG005', 'title': 'Cohort 3: Prednisolone 5mg', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}], 'classes': [{'title': 'Any Adverse Event (AE)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any AE with outcome = death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any SAE (including events with outcome = death)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any AE leading to discontinuation of Investigational Product', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any AE leading to drug interruption', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any AE leading to withdrawal from study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening up to 79 days', 'description': 'Safety and tolerability of AZD9567 was assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAF) consisted of all patients who were randomised to one of the 2 sequence groups within the cohort and have received at least 1 dose of study intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: 72 mg AZD9567 First, Then 40 mg Prednisolone', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone'}, {'id': 'FG001', 'title': 'Cohort 1:40 mg Prednisolone First, Then 72 mg AZD9567', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'FG002', 'title': 'Cohort 2: 40 mg AZD9567 First, Then 20 mg Prednisolone', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone'}, {'id': 'FG003', 'title': 'Cohort 2: 20mg Prednisolone First, Then 40 mg AZD9567', 'description': 'Patients were randomised in a ratio of 1:1 to receive 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'FG004', 'title': 'Cohort 3: Placebo First, Then 5 mg Prednisolone', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone'}, {'id': 'FG005', 'title': 'Cohort 3: 5 mg Prednisolone First, Then Placebo', 'description': 'Patients were randomised in a ratio of 1:1 to receive 5 mg prednisolone followed by placebo'}], 'periods': [{'title': 'Treatment Period 1 (72 Hours)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': "Positive SARS-CoV-2 rapid test for patient's daughter", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout Period (3 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2 (72 Hours)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted in Germany between 26 November 2020 and 09 June 2021.', 'preAssignmentDetails': 'Patients with type 2 diabetes mellitus who met all the eligibility criteria were randomised in a ratio of 1:1 to a cohort and sequence group. Each cohort was treated for two 72 hour periods in a cross-over design, with a 3-week washout period between treatment periods.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1', 'description': 'Patients were randomised in a ratio of 1:1 to receive 72 mg AZD9567 followed by 40 mg prednisolone or 40 mg prednisolone followed by 72 mg AZD9567'}, {'id': 'BG001', 'title': 'Cohort 2', 'description': 'Patients were randomised in a ratio of 1:1 to receive 40 mg AZD9567 followed by 20 mg prednisolone or 20 mg prednisolone followed by 40 mg AZD9567'}, {'id': 'BG002', 'title': 'Cohort 3', 'description': 'Patients were randomised in a ratio of 1:1 to receive placebo followed by 5 mg prednisolone or 5 mg prednisolone followed by placebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.3', 'spread': '6.41', 'groupId': 'BG000'}, {'value': '64.4', 'spread': '9.32', 'groupId': 'BG001'}, {'value': '66.6', 'spread': '5.36', 'groupId': 'BG002'}, {'value': '66.6', 'spread': '6.75', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) consisted of all randomised patients who received at least 1 dose of study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-03', 'size': 3693117, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-04-28T10:01', 'hasProtocol': True}, {'date': '2021-10-28', 'size': 5882296, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-04-28T10:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': "Both participants and investigators will be blinded. Investigators will remain blinded to each participant's assigned study intervention throughout the course of the study. In order to maintain this blind, a third party will be responsible for the reconstitution and dispensation of all study interventions."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2020-09-15', 'resultsFirstSubmitDate': '2022-04-28', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-02', 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Glucose Area Under the Plasma Concentration Versus Time Curve From Zero to 4 Hours Post-dose AUC(0-4)', 'timeFrame': 'On Days -1 (baseline), and Days 4 (Treatment period 1 and 2)', 'description': 'The change from baseline in glucose AUC(0-4) was analysed to determine the Pharmacodynamic (PD) effect of AZD9567 compared to Prednisolone following a standardised Mixed meal tolerance test (MMTT).\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}], 'secondaryOutcomes': [{'measure': 'Mean Glucose Level as Determined Via the Continuous Glucose Monitoring (CGM) System', 'timeFrame': '48 to 72 hours', 'description': 'The mean glucose levels in mmol/L at 48-72 h was analysed to determine the effect of AZD9567 on CGM compared to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Rise in Mean Glucose Levels Over 24-hour Periods From Start of IMP Dosing', 'timeFrame': 'Baseline and up to 72 hours (Treatment period 1 and 2)', 'description': 'The mean glucose level in mmol/L was analysed to determine the effect of AZD9567 on CGM compared to prednisolone.\n\nFor the calculation of the rise in mean glucose levels, the baseline was the average of the values from -24 hours to first dosing on Day 1 of each period.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Change From Baseline in Fasting Glucose', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Pharmacodynamic effects (fasting glucose) of AZD9567 following a MMTT were evaluated as compared to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Insulin)', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on insulin AUC(0-4) were assessed following MMTT compared to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Glucagon)', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on glucagon AUC(0-4) were assessed following MMTT in comparison to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Glucagon-like Peptide-1 [GLP-1])', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on GLP-1 AUC(0-4) were assessed following MMTT in comparison to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Glucose-dependent Insulin Releasing Polypeptide [GIP])', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on GIP AUC(0-4) were assessed following MMTT in comparison to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Change From Baseline in AUC(0-4) on C-peptide', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on C-peptide AUC(0-4) were assessed through a MMTT in comparison to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Change From Baseline in Ratio of Insulin to Glucose Level Between 10 and 0 Minutes (ΔI10/ΔG10)', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on ΔI10/ΔG10 of beta cell function from the MMTT compared to Prednisolone was evaluated.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Change From Baseline in Ratio of Insulin to Glucose Level Between 30 and 0 Minutes [ΔI30/ΔG30])', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on ΔI30/ΔG30 of beta cell function from the MMTT compared to Prednisolone was evaluated.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Change From Baseline in Ratio of C-peptide to Glucose Level Between 10 and 0 Minutes (ΔC10/ΔG10)', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on ΔC10/ΔG10 of beta cell function from the MMTT compared to Prednisolone was evaluated.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Change From Baseline in Ratio of C-peptide to Glucose Level Between 30 and 0 Minutes (ΔC30/ΔG30)', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on ΔC30/ΔG30 of beta cell function from the MMTT compared to Prednisolone was evaluated.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Change From Baseline in 24-hour Urinary Potassium Excretion', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'The concentration of potassium in urine was measured over 24 hours to determine the effect of AZD9567 on urinary potassium (U-K) excretion compared to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Change From Baseline in 24-hour Urinary Sodium Excretion', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'The concentration of sodium in urine was measured over 24 hours to determine the effect of AZD9567 on urinary-sodium (U-Na) excretion compared to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Quantifiable Concentration (AUClast)', 'timeFrame': 'Upto 30 hours post dose (Treatment period 1 and 2)', 'description': 'AUClast of AZD9567 following once daily dosing was evaluated.'}, {'measure': 'Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours Post-dose [AUC(0-24)]', 'timeFrame': '24 hours post dose', 'description': 'AUC(0-24) of AZD9567 following once daily dosing was evaluated.'}, {'measure': 'Area Under the Plasma Concentration Versus Time Curve From Zero to 6 Hours Post-dose [AUC(0-6)]', 'timeFrame': '6 hours post dose', 'description': 'AUC(0-6) of AZD9567 following once daily dosing was evaluated.'}, {'measure': 'Maximum Observed Drug Concentration (Cmax)', 'timeFrame': 'Upto 30 hours post dose (Treatment period 1 and 2)', 'description': 'Cmax of AZD9567 following once daily dosing was evaluated.'}, {'measure': 'Time to Reach Maximum Observed Drug Concentration (Tmax)', 'timeFrame': 'Upto 30 hours post dose (Treatment period 1 and 2)', 'description': 'Tmax of AZD9567 following once daily dosing was evaluated.'}, {'measure': 'Terminal Elimination Half-life (t½λz)', 'timeFrame': 'Upto 30 hours post dose (Treatment period 1 and 2)', 'description': 't½λz of AZD9567 following once daily dosing was evaluated.'}, {'measure': 'Apparent Total Body Clearance of Drug From Plasma After Extravascular (CL/F)', 'timeFrame': 'Upto 30 hours post dose (Treatment period 1 and 2)', 'description': 'CL/F of AZD9567 following once daily dosing was evaluated.'}, {'measure': 'Apparent Volume of Distribution Following Extravascular Administration (Vz/F)', 'timeFrame': 'Upto 30 hours post dose (Treatment period 1 and 2)', 'description': 'Vz/F of AZD9567 was derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).'}, {'measure': 'Tumour Necrosis Factor Alpha (TNFα) Concentrations', 'timeFrame': 'On Days 3 (Treatment period 1 and 2)', 'description': 'Relationship between AZD9567 exposure and inhibition of LPS-stimulated TNFα release for high and low dose comparison (Cohort 1 and Cohort 2) was assessed. LPS-stimulated TNFα concentration was measured.'}, {'measure': 'Change From Baseline AUC(0-4) on Hormones Related to Glucose Homeostasis (Free Fatty Acids)', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Effects of AZD9567 on free fatty acids were evaluated following a MMTT compared to prednisolone.\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Change From Baseline in Homeostatic Model Assessment- Insulin Resistance (HOMA-IR)', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'The HOMA-IR was calculated based on glucose and insulin measured prior to MMTT.\n\nHOMA-IR= Glucose(mmol/L) x Insulin (mU/L) / 22.5\n\nHOMA-IR score estimates the degree of insulin resistance. Higher range indicates greater insulin resistance (i.e. high diabetes risk), while lower range indicates insulin sensitivity (i.e. low diabetes risk)\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Change From Baseline in HOMA-insulin Sensitivity (HOMA-S)', 'timeFrame': 'On Day -1 (Baseline), and Day 4 (Treatment period 1 and 2)', 'description': 'Insulin sensitivity is a term used to indicate the responsiveness of the peripheral tissue cells to insulin, and their resultant capacity to uptake glucose out of the bloodstream.\n\nHOMA-S score estimates the degree of insulin sensitivity. HOMA-S was calculated as the reciprocal of HOMA-IR.\n\nHigher values indicates greater insulin sensitivity (i.e. low diabetes risk), while lower values indicates insulin resistance (i.e. high diabetes risk)\n\nIn Cohort 1 and 2, Placebo was not administered, therefore in Placebo row the participants analyzed is kept as 0.\n\nIn Cohort 3, AZD9567 was not administered, therefore in AZD9567 row the participants analyzed is kept 0.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From screening up to 79 days', 'description': 'Safety and tolerability of AZD9567 was assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'Glucose Homeostasis', 'Pharmacodynamic', 'AZD9567', 'Prednisolone'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6470C00005&attachmentIdentifier=d1a10878-6b4a-4320-a661-b3f7986b52b2&fileName=AZ_COMPASS_D6470C00005_(PXL_248030)_Final_Draft_SAP_Redacted.pdf&versionIdentifier=', 'label': 'Statistical Analysis Plan (SAP)'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6470C00005&attachmentIdentifier=f2221f84-9958-4ffd-8e89-e2f6ca7a105e&fileName=AZ_COMPASS_D6470C00005_(PXL_248030)_Final_Draft_Protocol_Redacted.pdf&versionIdentifier=', 'label': 'Protocol'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D6470C00005&attachmentIdentifier=5e02de02-bcd6-4401-ba0c-ae4becfb8118&fileName=AZ_COMPASS_D6470C00005_(PXL_248030)_Final_Draft_CSR_Synopsis_Redacted.pdf&versionIdentifier=', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The study is intended to assess the effect on glycaemic control of AZD9567, as measured by the glucose AUC(0-4) versus baseline following a standardised mixed meal tolerance test (MMTT), compared to prednisolone in adults with type 2 diabetes mellitus (T2DM). The study will also evaluate the safety, tolerability, and pharmacokinetics (PK) of AZD9567.', 'detailedDescription': 'This is a randomised, double blind, multi-centre, double dummy, and two-way cross-over study.\n\nThere will be a total of three cohorts. Each cohort will be treated for two 72-hour periods in a cross-over design, with a 3-week washout period between treatment periods. The total length of participant engagement (from screening to follow-up) is 79 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with diagnosis of T2DM for 6 months prior to screening: HbA1c in the diabetes range or fasting plasma glucose 126 -220 mg/dL.\n* On stable metformin therapy for at least 4 weeks, where no significant dose change (increase or decrease ≥ 500 mg/day) has occurred prior to screening and HbA1c 6% - 9.5%, or on dual therapy with metformin in combination with SGLT2i or DPP4i and HbA1c 6% - 8%. Participants on dual therapy will require 2 weeks wash-out of SGLT2i or DPP4i.\n* Venous access suitable for multiple cannulations\n* Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Female participants must be not lactating and not of childbearing potential.\n* If sexually active, nonsterilized males who have a female partner of childbearing potential must practice effective contraceptive measures.\n* Capable of giving signed informed consent.\n* Provision of informed consent prior to any study specific procedures.\n\nExclusion Criteria:\n\n* History or presence of type 1 diabetes.\n* History of severe hypoglycaemia or hypoglycaemia unawareness within the last 6 months.\n* History or presence of diabetic foot ulcers\n* Participants with advanced diabetic complications.\n* History of clinically significant lactic acidosis or ketoacidosis following diagnosis with T2DM.\n* History of, or known significant infection or positivity at Visit 1, including hepatitis A, B, or C, HIV, tuberculosis that may put the participant at risk during participation in the study.\n* History and / or presence of COVID-19.\n* Donation of blood (≥ 450 mL) within 3 months or donation of plasma within 14 days before Visit 1.\n* History of or current alcohol or drug abuse (including marijuana), as judged by the investigator.\n* Previous psychiatric disorders.\n* Any latent, acute, or chronic infections or at risk of infection, or history of skin abscesses within 90 days prior to the first administration of investigational medicinal product (IMP) at the discretion of the investigator.\n* History of adrenal insufficiency.\n* History or current inflammatory disorder.\n* Any other condition that, in the opinion of the investigator, would interfere with evaluations of the IMP or interpretation of participant safety or study results.\n* History of severe allergy/hypersensitivity to AZD9567 or any of the excipients of the product, or ongoing clinically important allergy/hypersensitivity as judged by the investigator.\n* Oral or parenteral steroids 8 weeks prior to randomisation and during the study. Topical and inhaled steroids 4 weeks prior to randomisation are acceptable.\n* Use of any prohibited medication during the study or if the required washout time of such medication was not adhered to.\n* Receipt of live or live attenuated vaccine within 4 weeks prior to the first administration of IMP.\n* Planned in-patient surgery, major dental procedure, or hospitalisation during the study.\n* Previous participation or participation in any other research study within 1 month prior to Visit 1.\n* Patient treated with any investigational drug within 30 days (or 5 half-lives, whichever is longer) prior to Visit 1.\n* Uncontrolled hypertension (BP \\> 160 mmHg systolic or \\> 95 mmHg diastolic).\n* Diagnosis of heart failure and current symptoms regardless of definition, ie, HfpEF, HfrEF.\n* Acute coronary syndrome / unstable angina, coronary intervention procedures (percutaneous coronary intervention or coronary artery bypass graft) within the past 6 months.\n* Stroke within the past 3 months.\n* QTcF \\> 470 ms or family history of long QT-syndrome.\n* AV-block II-III or sinus node dysfunction with significant pause, not treated with pacemaker.'}, 'identificationModule': {'nctId': 'NCT04556760', 'briefTitle': 'Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 2a Randomised, Double Blind, Multi-centre Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'D6470C00005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Participants will be randomised in a ratio of 1:1 to receive AZD9567 and prednisolone over two 72 hour periods in a cross over design (72 mg AZD9567 followed by 40 mg prednisolone \\[AB sequence group\\] or 40 mg prednisolone followed by 72 mg AZD9567 \\[BA sequence group\\]).', 'interventionNames': ['Drug: AZD9567', 'Drug: Prednisolone']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Participants will be randomised in a ratio of 1:1 to receive AZD9567 and prednisolone over two 72 hour periods in a cross over design (40 mg AZD9567 followed by 20 mg prednisolone \\[AB sequence group\\] or 20 mg prednisolone followed by 40 mg AZD9567 \\[BA sequence group\\]).', 'interventionNames': ['Drug: AZD9567', 'Drug: Prednisolone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 3', 'description': 'Participants will be randomised in a ratio of 1:1 to receive placebo and prednisolone over two 72 hour periods in a cross over design (placebo followed by 5 mg prednisolone \\[AB sequence group\\] or 5 mg prednisolone followed by placebo \\[BA sequence group\\]).', 'interventionNames': ['Drug: Prednisolone', 'Other: Placebo']}], 'interventions': [{'name': 'AZD9567', 'type': 'DRUG', 'description': 'Participants will receive 72 mg/day (oral suspension) of AZD9567 for 3 consecutive days of each treatment period in Cohort 1 and 40 mg/day for 3 consecutive days of each treatment period in Cohort 2.', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}, {'name': 'Prednisolone', 'type': 'DRUG', 'description': 'Participants will receive 40 mg/day of prednisolone for 3 consecutive days of each treatment period in Cohort 1, 20 mg/day of prednisolone for 3 consecutive days of each treatment period in Cohort 2, and 5 mg/day prednisolone for 3 consecutive days of each treatment period in Cohort 3.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Participants will receive placebo for 3 consecutive days of each treatment period in Cohort 3.', 'armGroupLabels': ['Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55116', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Tim Heise', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Profil Institut fur Stoffwechselforschung GmbH'}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.\n\nAdditionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Parexel', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}