Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-01-17 @ 9:24 AM
Study NCT ID:
NCT01800968
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
2013-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Functional Impact of GLP-1 for Heart Failure Treatment (FIGHT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adrian.hernandez@duke.edu', 'phone': '919-668-7515', 'title': 'Adrian Hernandez, MD', 'organization': 'Duke Clinical Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline to day 210.', 'description': 'All serious adverse events documented from baseline to day 210. According to protocol: Non-serious adverse events will not be collected on the eCRF but should be documented in source documents and followed according to local standard of care. Non-serious adverse events were not reported to sponsor, and therefore not reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous (SQ) daily.\n\nLiraglutide: Active Drug', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 154, 'seriousNumAffected': 33}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous (SQ) daily.\n\nPlacebo: Placebo', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 146, 'seriousNumAffected': 33}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Gastrointentinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hepatic Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'International Normalised Ratio Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Viral Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hyperolmolar Hyperglycaemic State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypoglycaemic unconsciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 146, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Global Ranking of Predefined Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '145.5', 'spread': '88.1', 'groupId': 'OG000'}, {'value': '155.7', 'spread': '85.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3087', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Rank score', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Randomization to 180 days', 'description': 'A rank score based on time to death, time to adjudicated heart failure hospitalization, and time-averaged proportional change in NTproBNP through d180. For patients that died, the patient with the shortest time from randomization to death is assigned rank 1, the second shortest time is assigned rank 2, etc. The patient with the longest time from randomization to death is assigned rank X. For patients that did not die but had a heart failure hospitalization, the patient with the shortest time from randomization to re-admission is assigned rank X+1 and the patient with the longest time from randomization to heart failure hospitalization is assigned rank Y. For patients that did not die or have a heart failure hospitalization, increases in time-averaged proportional change in NTproBNP indicate a worse result and the largest increase is assigned rank Y+1. The patient with the largest decrease is assigned rank N, where N is the sample size.', 'unitOfMeasure': 'rank', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular End-Diastolic Volume Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3.37', 'spread': '31.9', 'groupId': 'OG000'}, {'value': '-2.91', 'spread': '32.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1549', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 180 days', 'description': 'Change in Left Ventricular End-Diastolic Volume Index from baseline to 180 days.', 'unitOfMeasure': 'ml per meter squared', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular End-systolic Volume Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.16', 'spread': '26.2', 'groupId': 'OG000'}, {'value': '-3.47', 'spread': '26.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1932', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 180 days', 'description': 'Change in left ventricular end-systolic volume index from baseline to day 180.', 'unitOfMeasure': 'ml per meter squared', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular Ejection Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.07', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '10.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9535', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 180 days', 'description': 'Change in left ventricular ejection fraction from baseline to day 180', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Medial Filling Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.12', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '17.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8548', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 180 days', 'description': 'Change in medial filling pressure baseline to day 180.', 'unitOfMeasure': 'm/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Lateral Filling Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.05', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '13.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4266', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 180 days', 'description': 'Change in lateral filling pressure baseline to day 180.', 'unitOfMeasure': 'm/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change in 6 Minute Walk Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '50.4', 'spread': '110.8', 'groupId': 'OG000'}, {'value': '37.3', 'spread': '99.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1705', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to day 30', 'description': 'Change in 6 minute walk distance baseline to day 30', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change in 6 Minute Walk Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '56.8', 'spread': '132.7', 'groupId': 'OG000'}, {'value': '38.7', 'spread': '115.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1309', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days', 'description': 'Change in 6 minute walk distance baseline to 90 days.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change in 6 Minute Walk Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'spread': '133.9', 'groupId': 'OG000'}, {'value': '55.3', 'spread': '127.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7920', 'groupIds': ['OG000'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 180 days', 'description': 'Change in 6 minute walk distance baseline to 180 days.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '14.69', 'spread': '25.90', 'groupId': 'OG000'}, {'value': '14.44', 'spread': '22.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7026', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 30 days', 'description': 'Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 30 days. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '13.86', 'spread': '24.99', 'groupId': 'OG000'}, {'value': '11.72', 'spread': '23.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2662', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days', 'description': 'Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '13.79', 'spread': '23.83', 'groupId': 'OG000'}, {'value': '13.14', 'spread': '23.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6395', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to day 180', 'description': 'Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to day 180.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '12.98', 'spread': '23.82', 'groupId': 'OG000'}, {'value': '14.01', 'spread': '20.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8218', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 30 days', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 30 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '14.17', 'spread': '24.46', 'groupId': 'OG000'}, {'value': '10.62', 'spread': '22.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1124', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '13.44', 'spread': '22.61', 'groupId': 'OG000'}, {'value': '13.25', 'spread': '22.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8088', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 180 days', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 180 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Individual Component of the Primary Endpoint- Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7764', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to 180 days', 'description': 'Individual component of the primary endpoint of mortality at 180 days after randomization', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Individual Component of the Primary Endpoint- Heart Failure Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1701', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to 180 days', 'description': 'Individual component of the primary endpoint- Heart Failure hospitalization from randomization to 180 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '335.81', 'spread': '445.8', 'groupId': 'OG000'}, {'value': '317', 'spread': '307.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6532', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 180 days', 'description': 'Individual component of the primary endpoint- time-averaged proportional change in NT-proBNP from baseline to 180 days', 'unitOfMeasure': 'weighted average of ratio to baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Global Ranking of Predefined Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '144.29', 'spread': '87.63', 'groupId': 'OG000'}, {'value': '157.05', 'spread': '85.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2033', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Rank score', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 180 days', 'description': 'A rank score based on time to death, time to adjudicated heart failure hospitalization, time to emergency department visit and time-averaged proportional change in NTproBNP through d180. See Outcome Measure 1 for a general description of the outcome derivation.', 'unitOfMeasure': 'rank', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '146'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.\n\nLiraglutide: Active Drug'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.\n\nPlacebo: Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.9', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '59.6', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '59.7', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All patients randomized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2013-02-07', 'resultsFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2013-02-26', 'lastUpdatePostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-14', 'studyFirstPostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Ranking of Predefined Events', 'timeFrame': 'Randomization to 180 days', 'description': 'A rank score based on time to death, time to adjudicated heart failure hospitalization, and time-averaged proportional change in NTproBNP through d180. For patients that died, the patient with the shortest time from randomization to death is assigned rank 1, the second shortest time is assigned rank 2, etc. The patient with the longest time from randomization to death is assigned rank X. For patients that did not die but had a heart failure hospitalization, the patient with the shortest time from randomization to re-admission is assigned rank X+1 and the patient with the longest time from randomization to heart failure hospitalization is assigned rank Y. For patients that did not die or have a heart failure hospitalization, increases in time-averaged proportional change in NTproBNP indicate a worse result and the largest increase is assigned rank Y+1. The patient with the largest decrease is assigned rank N, where N is the sample size.'}], 'secondaryOutcomes': [{'measure': 'Change in Left Ventricular End-Diastolic Volume Index', 'timeFrame': 'Baseline to 180 days', 'description': 'Change in Left Ventricular End-Diastolic Volume Index from baseline to 180 days.'}, {'measure': 'Change in Left Ventricular End-systolic Volume Index', 'timeFrame': 'Baseline to 180 days', 'description': 'Change in left ventricular end-systolic volume index from baseline to day 180.'}, {'measure': 'Change in Left Ventricular Ejection Fraction', 'timeFrame': 'Baseline to 180 days', 'description': 'Change in left ventricular ejection fraction from baseline to day 180'}, {'measure': 'Change in Medial Filling Pressure', 'timeFrame': 'Baseline to 180 days', 'description': 'Change in medial filling pressure baseline to day 180.'}, {'measure': 'Change in Lateral Filling Pressure', 'timeFrame': 'Baseline to 180 days', 'description': 'Change in lateral filling pressure baseline to day 180.'}, {'measure': 'Change in 6 Minute Walk Distance', 'timeFrame': 'Baseline to day 30', 'description': 'Change in 6 minute walk distance baseline to day 30'}, {'measure': 'Change in 6 Minute Walk Distance', 'timeFrame': 'Baseline to 90 days', 'description': 'Change in 6 minute walk distance baseline to 90 days.'}, {'measure': 'Change in 6 Minute Walk Distance', 'timeFrame': 'Baseline to 180 days', 'description': 'Change in 6 minute walk distance baseline to 180 days.'}, {'measure': 'Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'timeFrame': 'Baseline to 30 days', 'description': 'Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 30 days. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.'}, {'measure': 'Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'timeFrame': 'Baseline to 90 days', 'description': 'Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.'}, {'measure': 'Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)', 'timeFrame': 'Baseline to day 180', 'description': 'Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to day 180.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.'}, {'measure': 'Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score', 'timeFrame': 'Baseline to 30 days', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 30 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.'}, {'measure': 'Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score', 'timeFrame': 'Baseline to 90 days', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.'}, {'measure': 'Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.', 'timeFrame': 'Baseline to 180 days', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 180 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.'}, {'measure': 'Individual Component of the Primary Endpoint- Mortality', 'timeFrame': 'Randomization to 180 days', 'description': 'Individual component of the primary endpoint of mortality at 180 days after randomization'}, {'measure': 'Individual Component of the Primary Endpoint- Heart Failure Hospitalization', 'timeFrame': 'Randomization to 180 days', 'description': 'Individual component of the primary endpoint- Heart Failure hospitalization from randomization to 180 days'}, {'measure': 'Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP', 'timeFrame': 'Baseline to 180 days', 'description': 'Individual component of the primary endpoint- time-averaged proportional change in NT-proBNP from baseline to 180 days'}, {'measure': 'Global Ranking of Predefined Events', 'timeFrame': 'Baseline to 180 days', 'description': 'A rank score based on time to death, time to adjudicated heart failure hospitalization, time to emergency department visit and time-averaged proportional change in NTproBNP through d180. See Outcome Measure 1 for a general description of the outcome derivation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Heart Failure']}, 'referencesModule': {'references': [{'pmid': '35654972', 'type': 'DERIVED', 'citation': 'Lerman JB, Giamberardino SN, Hernandez AF, Felker GM, Shah SH, McGarrah RW. Plasma metabolites associated with functional and clinical outcomes in heart failure with reduced ejection fraction with and without type 2 diabetes. Sci Rep. 2022 Jun 2;12(1):9183. doi: 10.1038/s41598-022-12973-0.'}, {'pmid': '32362166', 'type': 'DERIVED', 'citation': 'Redouane B, Greene SJ, Fudim M, Vaduganathan M, Ambrosy AP, Sun JL, DeVore AD, McNulty SE, Mentz RJ, Hernandez AF, Felker GM, Cooper LB, Borlaug BA, Velazquez EJ, Margulies KB, Sharma A. Effects of Liraglutide on Worsening Renal Function Among Patients With Heart Failure With Reduced Ejection Fraction: Insights From the FIGHT Trial. Circ Heart Fail. 2020 May;13(5):e006758. doi: 10.1161/CIRCHEARTFAILURE.119.006758. Epub 2020 May 4.'}, {'pmid': '30120812', 'type': 'DERIVED', 'citation': 'Sharma A, Ambrosy AP, DeVore AD, Margulies KB, McNulty SE, Mentz RJ, Hernandez AF, Michael Felker G, Cooper LB, Lala A, Vader J, Groake JD, Borlaug BA, Velazquez EJ. Liraglutide and weight loss among patients with advanced heart failure and a reduced ejection fraction: insights from the FIGHT trial. ESC Heart Fail. 2018 Dec;5(6):1035-1043. doi: 10.1002/ehf2.12334. Epub 2018 Aug 17.'}, {'pmid': '27483064', 'type': 'DERIVED', 'citation': 'Margulies KB, Hernandez AF, Redfield MM, Givertz MM, Oliveira GH, Cole R, Mann DL, Whellan DJ, Kiernan MS, Felker GM, McNulty SE, Anstrom KJ, Shah MR, Braunwald E, Cappola TP; NHLBI Heart Failure Clinical Research Network. Effects of Liraglutide on Clinical Stability Among Patients With Advanced Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA. 2016 Aug 2;316(5):500-8. doi: 10.1001/jama.2016.10260.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to test the hypothesis that, compared with placebo, therapy with Subcutaneous (SQ) GLP-1 agonist in the post-Acute Heart Failure Syndrome (AHFS) discharge period will be associated with greater clinical stability at six months as assessed by a composite clinical endpoint.', 'detailedDescription': 'Hospitalization for AHFS identifies individuals at increased risk of death and re-hospitalization following discharge. This increased risk justifies intervention with novel therapy during the vulnerable post-discharge period to enhance clinical stability and prevent early HF mortality and readmissions.\n\nAs heart failure (HF) progresses, impairments in metabolism render the heart substrate constrained, limiting cardiac metabolism. Glucagon-like peptide-1 (GLP-1) is a naturally occurring incretin peptide that enhances cellular glucose uptake by stimulating insulin secretion and insulin sensitivity in target tissues. Preclinical and early-phase clinical data support GLP-1 as an effective therapy for advanced HF while use of GLP-1 receptor agonists in large numbers of patients with diabetes reveal a good safety profile and reductions in adverse cardiac outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. AHFS as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography)\n3. AHFS is the primary cause of hospitalization\n4. Prior clinical diagnosis of HF\n5. Left Ventricular Ejection Fraction(LVEF) ≤ 40% during the preceding 3 months (if no echo within the preceding 3 months, an LVEF ≤ 30% during the preceding three years is acceptable)\n6. On evidence-based medication for HF (including beta-blocker and ACE-inhibitor/ARB) or previously deemed intolerant\n7. Use of at least 80 mg or furosemide total daily dose (or equivalent) prior to admission for AHFS (a lower dose of a loop diuretic combined with a thiazide will count as an "equivalent")\n8. Willingness to provide informed consent\n\nExclusion Criteria:\n\n1. AHFS due to acute myocarditis or acute Myocardial Infarction\n2. Ongoing hemodynamically significant arrhythmias contributing to HF decompensation\n3. Inotrope, intra-aortic balloon pump (IABP) or other mechanical circulatory support use at the time of consent. Prior use will not exclude a patient.\n4. Current or planned left ventricular assist device therapy in next 180 days\n5. United Network for Organ Sharing status 1A or 1B\n6. B-type natriuretic peptide(BNP)\\< 250 or NT-proBNP\\<1,000 (Not required per protocol but if available and too low would be an exclusion; within 48 hours of consent)\n7. Hemoglobin (Hgb) \\< 8.0 g/dl\n8. Glomerular filtration rate(GFR) \\< 20 ml/min/1.73 m2 within 48 hours of consent\n9. Systolic blood pressure \\< 80 mmHg at consent\n10. Resting Heart Rate \\> 110 at consent\n11. Acute coronary syndrome within 4 weeks as defined by electrocardiographic (ECG) changes and biomarkers of myocardial necrosis (e.g. troponin) in an appropriate clinical setting (chest discomfort or anginal equivalent)\n12. Percutaneous Coronary Intervention, coronary artery bypass grafting or new biventricular pacing within past 4 weeks\n13. Primary hypertrophic cardiomyopathy\n14. Infiltrative cardiomyopathy\n15. Constrictive pericarditis or tamponade\n16. Complex congenital heart disease\n17. Non-cardiac pulmonary edema\n18. More than moderate aortic or mitral stenosis\n19. Intrinsic (prolapse, rheumatic) valve disease with severe mitral, aortic or tricuspid regurgitation\n20. Sepsis, active infection (excluding cystitis) or other comorbidity driving the HF decompensation\n21. Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, International Normalized Ration (INR) \\> 1.7 in the absence of anticoagulation treatment\n22. Terminal illness (other than HF) with expected survival of less than 1 year\n23. Previous adverse reaction to the study drug\n24. Receipt of any investigational product in the previous 30 days.\n25. Enrollment or planned enrollment in another randomized therapeutic clinical trial in next 6 months.\n26. Inability to comply with planned study procedures\n27. Pregnancy or breastfeeding mothers\n28. Women of reproductive age not on adequate contraception\n29. History of acute or chronic pancreatitis\n30. History of symptomatic gastroparesis\n31. Familial or personal history of medullary thyroid cancer or multiple endocrine neoplasia type-2 (MEN2)\n32. Prior weight-loss surgery (i.e., Roux-en-Y gastric bypass) or other gastric surgery associated with increased endogenous GLP-1 production\n33. Prior or ongoing treatment with GLP-1 receptor agonists\n34. Ongoing treatment with dipeptidyl peptide-IV inhibitors (1 week washout required)\n35. Ongoing treatment with thiazolidinedione\n36. Oxygen-dependent chronic obstructive pulmonary disease\n37. Diabetic patients with history of 2 or more severe hypoglycemia, Diabetic Ketoacidosis(DKA) or hyperglycemic, hyperosmotic nonketotic coma in the preceding 12 months.\n38. Diagnosis of Type 1 Diabetes Mellitus\n\n40\\. If diabetic, inadequate glycemic control with glucose level \\> 300 mg/dL within 24 hours of randomization'}, 'identificationModule': {'nctId': 'NCT01800968', 'acronym': 'FIGHT', 'briefTitle': 'Functional Impact of GLP-1 for Heart Failure Treatment (FIGHT)', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Functional Impact of GLP-1 for Heart Failure Treatment', 'orgStudyIdInfo': {'id': 'Pro00042633'}, 'secondaryIdInfos': [{'id': '5U10HL084904-09', 'link': 'https://reporter.nih.gov/quickSearch/5U10HL084904-09', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liraglutide', 'description': 'Increasing dose from 0.6mg, 1.2mg to 1.8mg SQ daily.', 'interventionNames': ['Drug: Liraglutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg SQ daily.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Liraglutide', 'type': 'DRUG', 'otherNames': ['Victoza'], 'description': 'Active Drug', 'armGroupLabels': ['Liraglutide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health Services', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02132', 'city': 'West Roxbury', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston VA Healtcare System', 'geoPoint': {'lat': 42.27926, 'lon': -71.1495}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63117', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28538', 'city': 'Lumberton', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Southeast Regional Medical Center', 'geoPoint': {'lat': 34.61834, 'lon': -79.01045}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals- Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Metro Health System', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '17603', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lancaster Heart and Stroke Foundation', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvaina', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson Medical College', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael Debakey VA Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84157', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah School of Medicine', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah VA Medical Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'The University of Vermont- Fletcher Allen Health Care', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Adrian Hernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Eugene Bruanwald, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Harvard University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}