Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-24 @ 11:43 PM
Study NCT ID:
NCT02642159
Status:
COMPLETED
Last Update Posted:
2018-05-01
First Post:
2015-12-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571059', 'term': 'alirocumab'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}, {'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D011345', 'term': 'Fenofibrate'}, {'id': 'D009525', 'term': 'Niacin'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}], 'ancestors': [{'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '1#', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 32) regardless of seriousness or relationship to investigational product.', 'description': "Reported AEs and deaths are TEAEs that are AEs that developed/worsened and death that occurred during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days).", 'eventGroups': [{'id': 'EG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.', 'otherNumAtRisk': 275, 'deathsNumAtRisk': 275, 'otherNumAffected': 37, 'seriousNumAtRisk': 275, 'deathsNumAffected': 1, 'seriousNumAffected': 26}, {'id': 'EG001', 'title': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.", 'otherNumAtRisk': 137, 'deathsNumAtRisk': 137, 'otherNumAffected': 27, 'seriousNumAtRisk': 137, 'deathsNumAffected': 0, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Diabetic foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}, {'term': 'Vaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-37.3', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-32.5', 'ciLowerLimit': '-38.1', 'ciUpperLimit': '-27.0', 'pValueComment': 'Threshold for significance \\<=0.025.', 'estimateComment': 'Alirocumab vs. usual care', 'groupDescription': 'Alirocumab group was compared to usual care group using an appropriate contrast statement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized participants with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care: Intent to Prescribe Fenofibrate', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-41.7', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '-8.5', 'spread': '4.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-33.3', 'ciLowerLimit': '-46.6', 'ciUpperLimit': '-19.9', 'pValueComment': 'Threshold for significance \\<=0.025.', 'estimateComment': 'Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)', 'groupDescription': 'Alirocumab group was compared to usual care group for the intent to prescribe fenofibrate using an appropriate contrast statement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-43.3', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '4.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-43.0', 'ciLowerLimit': '-49.7', 'ciUpperLimit': '-36.3', 'pValueComment': 'Threshold for significance \\<=0.025.', 'estimateComment': 'Alirocumab vs. usual care', 'groupDescription': 'A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses for overall ITT analysis. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants of the ITT population with one baseline and at least one post-baseline LDL-C value on-or off-treatment (LDL-C ITT population).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care: Intent to Prescribe Fenofibrate', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-47.0', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '5.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-55.7', 'ciLowerLimit': '-71.8', 'ciUpperLimit': '-39.6', 'pValueComment': 'Threshold for significance \\<=0.025.', 'estimateComment': 'Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)', 'groupDescription': 'A separate hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses for ITT-intent to prescribe fenofibrate stratum. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "LDL-C ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-35.5', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '-9.4', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-26.1', 'ciLowerLimit': '-31.5', 'ciUpperLimit': '-20.7', 'pValueComment': 'Threshold for significance \\<=0.025.', 'estimateComment': 'Alirocumab vs. usual care', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care: Intent to Prescribe Fenofibrate', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-34.7', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '4.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-27.4', 'ciLowerLimit': '-40.0', 'ciUpperLimit': '-14.8', 'pValueComment': 'Threshold for significance \\<=0.025.', 'estimateComment': 'Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT-intent to prescribe fenofibrate stratum was statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-41.7', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-34.7', 'ciLowerLimit': '-40.8', 'ciUpperLimit': '-28.6', 'pValueComment': 'Threshold for significance \\<=0.025.', 'estimateComment': 'Alirocumab vs. usual care', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'LDL-C ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care: Intent to Prescribe Fenofibrate', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-44.3', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-49.7', 'ciLowerLimit': '-63.7', 'ciUpperLimit': '-35.8', 'pValueComment': 'Threshold for significance \\<=0.025.', 'estimateComment': 'Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT-intent to prescribe fenofibrate stratum was statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "LDL-C ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-33.8', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-32.3', 'ciLowerLimit': '-37.3', 'ciUpperLimit': '-27.2', 'pValueComment': 'Threshold for significance \\<=0.025.', 'estimateComment': 'Alirocumab vs. usual care', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants of the ITT population with one baseline and at least one post-baseline Apo-B value on-or off-treatment (Apo-B ITT population).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care: Intent to Prescribe Fenofibrate', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-38.9', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-35.2', 'ciLowerLimit': '-47.4', 'ciUpperLimit': '-22.9', 'pValueComment': 'Threshold for significance \\<=0.025.', 'estimateComment': 'Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Apo-B ITT population.Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-27.4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-24.6', 'ciLowerLimit': '-28.8', 'ciUpperLimit': '-20.3', 'pValueComment': 'Threshold for significance \\<=0.025.', 'estimateComment': 'Alirocumab vs. usual care', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care: Intent to Prescribe Fenofibrate', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-30.9', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-5.7', 'spread': '3.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-25.3', 'ciLowerLimit': '-35.4', 'ciUpperLimit': '-15.1', 'pValueComment': 'Threshold for significance \\<=0.025.', 'estimateComment': 'Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Total-C ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lipoprotein(a) at Week 24 : Overall ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-23.7', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-27.4', 'ciLowerLimit': '-34.6', 'ciUpperLimit': '-20.1', 'pValueComment': 'Threshold for significance \\<=0.025.', 'estimateComment': 'Alirocumab vs. usual care', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).', 'statisticalMethod': 'Regression, Robust', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Multiple imputation approach followed by robust regression model.'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were included in the imputation model.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care: Intent to Prescribe Fenofibrate', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-18.9', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '6.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0040', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-22.8', 'ciLowerLimit': '-40.6', 'ciUpperLimit': '-5.0', 'pValueComment': 'Threshold for significance \\<=0.025.', 'estimateComment': 'Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).', 'statisticalMethod': 'Regression, Robust', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Multiple imputation approach followed by robust regression model.'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Triglycerides at Week 24: Overall ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-13.0', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '-8.8', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2191', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-4.2', 'ciLowerLimit': '-11.8', 'ciUpperLimit': '3.4', 'pValueComment': 'Threshold for significance \\<=0.025.', 'estimateComment': 'Alirocumab vs. usual care', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).', 'statisticalMethod': 'Regression, Robust', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Multiple imputation approach followed by robust regression.'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care: Intent to Prescribe Fenofibrate', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-15.4', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '-24.4', 'spread': '6.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2651', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '9.0', 'ciLowerLimit': '-9.1', 'ciUpperLimit': '27.1', 'pValueComment': 'Threshold for significance \\<=0.025.', 'groupDescription': 'Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).', 'statisticalMethod': 'Regression, Robust', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Multiple imputation approach followed by robust regression.', 'otherAnalysisDescription': 'Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in HDL-C at Week 24 : Overall ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care: Intent to Prescribe Fenofibrate', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "HDL-C ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-41.6', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'LDL-C particle number was calculated from lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants of the ITT population with one baseline and at least one post-baseline LDL-C particle number on- or off-treatment (LDL-C particle number ITT population).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care: Intent to Prescribe Fenofibrate', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy with fenofibrate as per Investigator's judgment for 24 weeks."}], 'classes': [{'categories': [{'measurements': [{'value': '-45.4', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '5.0', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline to Week 24', 'description': 'LDL-C particle number was calculated from lipid subfractions by NMR spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "LDL-C particle number ITT population. Here, 'Number of participants analyzed' = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 and 24 : Overall ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks."}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.59', 'spread': '6.82', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '5.70', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.84', 'spread': '8.04', 'groupId': 'OG000'}, {'value': '2.40', 'spread': '8.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 and 24', 'description': 'Absolute change = HbA1c value at specified week minus HbA1c value at baseline.', 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and 24 : Overall ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks."}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '1.86', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.68', 'spread': '2.54', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '2.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 and 24', 'description': 'Absolute change = FPG value at specified week minus FPG value at baseline.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Week 12 and 24 : Overall ITT Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks."}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 and 24', 'description': 'Glucose lowering treatment was calculated for non-insulin treatments as one for each unique treatment received and for insulin treatment as one in total for all participants who have taken one or more treatments. Absolute change = number of glucose-lowering treatments at specified week minus baseline value.', 'unitOfMeasure': 'Glucose lowering treatments', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other lipid modifying therapies (LMT) for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-high-density lipoprotein cholesterol (non-HDL-C) levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'FG001', 'title': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized', 'groupId': 'FG000', 'numSubjects': '276'}, {'comment': 'Randomized', 'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'Treated (Safety Population)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '275'}, {'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'ITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '273'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'ITT: Intent to Prescribe Fenofibrate', 'achievements': [{'comment': "Fenofibrate was only 'intended to prescribe' in the Alirocumab arm but not actually administered.", 'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'comment': 'Completed = treatment completion', 'achievements': [{'groupId': 'FG000', 'numSubjects': '245'}, {'groupId': 'FG001', 'numSubjects': '129'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Poor compliance to study protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other than specified above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The study was conducted at 119 centers in 15 countries. A total of 864 participants were screened between March 2016 and September 2016, 451 of whom were screen failures. Screen failures were mainly due to inclusion criteria not met.', 'preAssignmentDetails': "Randomization was stratified by investigator's choice of usual care therapy, which was pre-specified prior to randomization. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 2:1 ratio (alirocumab: usual care) after confirmation of selection criteria. 413 participants were randomized."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '413', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg SC injection Q2W added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-HDL-C levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '64.1', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '63.2', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '240', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '363', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '370', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Asian/Oriental', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Non-HDL-C', 'classes': [{'categories': [{'measurements': [{'value': '155.1', 'spread': '46.2', 'groupId': 'BG000'}, {'value': '161.5', 'spread': '48.8', 'groupId': 'BG001'}, {'value': '157.2', 'spread': '47.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'non-HDL-C = Total cholesterol (Total-C) minus high-density lipoprotein cholesterol (HDL-C)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Non-HDL-C', 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '4.2', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '4.073', 'spread': '1.221', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'non-HDL-C = Total-C minus HDL-C', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Intent to Prescribe Treatment', 'classes': [{'categories': [{'title': 'Fenofibrate', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'No additional LMT', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': 'Ezetimibe', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}, {'title': 'Omega-3 fatty acids', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Nicotinic acid', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Randomization was stratified by the Investigator's selection of usual care therapy prior to randomization. LMTs were only 'intended to prescribe' in the Alirocumab arm but not actually administered.", 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline population included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-11-18', 'size': 936787, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-19T14:50', 'hasProtocol': True}, {'date': '2017-04-26', 'size': 755349, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-03-19T14:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 413}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-15'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2015-12-24', 'resultsFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2015-12-24', 'lastUpdatePostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-30', 'studyFirstPostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).'}, {'measure': 'Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis', 'timeFrame': 'From Baseline to Week 24', 'description': 'Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.'}, {'measure': 'Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum', 'timeFrame': 'From Baseline to Week 24', 'description': 'Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.'}, {'measure': 'Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.'}, {'measure': 'Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.'}, {'measure': 'Percent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis', 'timeFrame': 'From Baseline to Week 24', 'description': 'Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.'}, {'measure': 'Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum', 'timeFrame': 'From Baseline to Week 24', 'description': 'Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.'}, {'measure': 'Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT Analysis', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.'}, {'measure': 'Percent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.'}, {'measure': 'Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT Analysis', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.'}, {'measure': 'Percent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.'}, {'measure': 'Percent Change From Baseline in Lipoprotein(a) at Week 24 : Overall ITT Analysis', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were included in the imputation model.'}, {'measure': 'Percent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.'}, {'measure': 'Percent Change From Baseline in Fasting Triglycerides at Week 24: Overall ITT Analysis', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.'}, {'measure': 'Percent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.'}, {'measure': 'Percent Change From Baseline in HDL-C at Week 24 : Overall ITT Analysis', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.'}, {'measure': 'Percent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum', 'timeFrame': 'From Baseline to Week 24', 'description': 'Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.'}, {'measure': 'Percent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT Analysis', 'timeFrame': 'From Baseline to Week 24', 'description': 'LDL-C particle number was calculated from lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.'}, {'measure': 'Percent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum', 'timeFrame': 'From Baseline to Week 24', 'description': 'LDL-C particle number was calculated from lipid subfractions by NMR spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.'}, {'measure': 'Absolute Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 and 24 : Overall ITT Analysis', 'timeFrame': 'Baseline, Week 12 and 24', 'description': 'Absolute change = HbA1c value at specified week minus HbA1c value at baseline.'}, {'measure': 'Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and 24 : Overall ITT Analysis', 'timeFrame': 'Baseline, Week 12 and 24', 'description': 'Absolute change = FPG value at specified week minus FPG value at baseline.'}, {'measure': 'Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Week 12 and 24 : Overall ITT Analysis', 'timeFrame': 'Baseline, Week 12 and 24', 'description': 'Glucose lowering treatment was calculated for non-insulin treatments as one for each unique treatment received and for insulin treatment as one in total for all participants who have taken one or more treatments. Absolute change = number of glucose-lowering treatments at specified week minus baseline value.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '33078867', 'type': 'DERIVED', 'citation': 'Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.'}, {'pmid': '32035487', 'type': 'DERIVED', 'citation': 'Colhoun HM, Leiter LA, Muller-Wieland D, Cariou B, Ray KK, Tinahones FJ, Domenger C, Letierce A, Israel M, Samuel R, Del Prato S. Effect of alirocumab on individuals with type 2 diabetes, high triglycerides, and low high-density lipoprotein cholesterol. Cardiovasc Diabetol. 2020 Feb 8;19(1):14. doi: 10.1186/s12933-020-0991-1.'}, {'pmid': '31706300', 'type': 'DERIVED', 'citation': 'Ray KK, Del Prato S, Muller-Wieland D, Cariou B, Colhoun HM, Tinahones FJ, Domenger C, Letierce A, Mandel J, Samuel R, Bujas-Bobanovic M, Leiter LA. Alirocumab therapy in individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease: analysis of the ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies. Cardiovasc Diabetol. 2019 Nov 9;18(1):149. doi: 10.1186/s12933-019-0951-9.'}, {'pmid': '29436756', 'type': 'DERIVED', 'citation': 'Ray KK, Leiter LA, Muller-Wieland D, Cariou B, Colhoun HM, Henry RR, Tinahones FJ, Bujas-Bobanovic M, Domenger C, Letierce A, Samuel R, Del Prato S. Alirocumab vs usual lipid-lowering care as add-on to statin therapy in individuals with type 2 diabetes and mixed dyslipidaemia: The ODYSSEY DM-DYSLIPIDEMIA randomized trial. Diabetes Obes Metab. 2018 Jun;20(6):1479-1489. doi: 10.1111/dom.13257. Epub 2018 Mar 23.'}, {'pmid': '28545518', 'type': 'DERIVED', 'citation': 'Muller-Wieland D, Leiter LA, Cariou B, Letierce A, Colhoun HM, Del Prato S, Henry RR, Tinahones FJ, Aurand L, Maroni J, Ray KK, Bujas-Bobanovic M. Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk. Cardiovasc Diabetol. 2017 May 25;16(1):70. doi: 10.1186/s12933-017-0552-4.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled with maximally tolerated statin therapy.\n\nSecondary Objectives:\n\n* To demonstrate whether alirocumab is superior in comparison with usual care in its effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp\\[a\\]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III), lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle size and LDL, very low-density lipoprotein \\[VLDL\\], HDL, and intermediate-density lipoprotein \\[IDL\\] particle number).\n* To assess changes in glycemic parameters with alirocumab vs. usual care treatment.\n* To demonstrate the safety and tolerability of alirocumab.\n* To evaluate treatment acceptance of alirocumab.\n* To evaluate proprotein convertase subtilisin kexin type 9 (PCSK9) concentrations and antibody development.\n* To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other lipid parameters (subgroup analysis).', 'detailedDescription': 'The maximum study duration was approximately 9 months per participant, including a 6 month treatment period, a screening period of up to 3 weeks, and an 8 week safety observation period.\n\nFor the purpose of scientific communication, a first-step analysis (both efficacy and safety) was performed at the Week 24 cut-off date. A second-step analysis was performed once all participants had completed the study to include a final update of the safety analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Participants with type 2 diabetes and mixed dyslipidemia whose non-HDL-C was not adequately controlled with a stable, maximum dose/regimen of statin that was tolerated by the participant.\n* 18 years of age or more.\n* Documented history of atherosclerotic cardiovascular disease (ASCVD) or at least one additional cardiovascular risk factor.\n* Non-HDL-C of 100 mg/dL or greater.\n* Triglycerides greater than or equal to 150 mg/dL and less than 500 mg/dL.\n* Stable anti-hyperglycemic agents for at least 3 months prior to the screening visit and between screening and randomization (including stable insulin dose defined as no variation more than 30% in daily insulin dose within the preceding 3 months, as judged by the Investigator).\n* No change in weight of more than 5 kg within the prior 3 months.\n* On stable dose of medications that are known to influence weight and/or lipids within the last 3 months.\n\nExclusion criteria:\n\n* Use of any lipid modifying therapies other than statins within the last 4 weeks (eg, ezetimibe, fenofibrate, nicotinic acid, omega-3 fatty acids, etc.) or use of over the counter products/nutraceuticals known to impact lipids (eg, red yeast rice) within the last 4 weeks.\n* Currently drinking more than 2 standard alcoholic drinks per day.\n* Body Mass Index (BMI) \\>45 kg/m² or currently enrolled in a weight loss program and still in active phase of weight loss.\n* Glycosylated hemoglobin (HbA1c) 9% or greater.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02642159', 'briefTitle': 'Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab Versus Usual Care in Patients With Type 2 Diabetes and Mixed Dyslipidemia at High Cardiovascular Risk With Non-HDL-C Not Adequately Controlled With Maximally Tolerated Statin Therapy', 'orgStudyIdInfo': {'id': 'LPS14354'}, 'secondaryIdInfos': [{'id': '2015-001934-19', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1172-5262', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'description': 'Alirocumab 75 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without other lipid modifying therapy (LMT) for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when non-high-density lipoprotein cholesterol (non-HDL-C) levels \\>=100 mg/dL (2.59 mmol/L) at Week 8.', 'interventionNames': ['Drug: Alirocumab', 'Drug: Statins', 'Drug: Antihyperglycemic Drug']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': "Participants on usual care continued on insulin or other antihyperglycemic drugs, stable maximally tolerated dose of statin therapy without additional LMT or with either ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid as per Investigator's judgment for 24 weeks.", 'interventionNames': ['Drug: Statins', 'Drug: Ezetimibe', 'Drug: Fenofibrate', 'Drug: Nicotinic acid', 'Drug: Omega-3 fatty acids', 'Drug: Antihyperglycemic Drug']}], 'interventions': [{'name': 'Alirocumab', 'type': 'DRUG', 'otherNames': ['SAR236553', 'REGN727', 'Praluent'], 'description': 'Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.', 'armGroupLabels': ['Alirocumab 75 mg Q2W/Up to 150 mg Q2W']}, {'name': 'Statins', 'type': 'DRUG', 'description': 'Statins at stable dose without other LMT as clinically indicated.', 'armGroupLabels': ['Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'Usual Care']}, {'name': 'Ezetimibe', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablet Route of administration: oral', 'armGroupLabels': ['Usual Care']}, {'name': 'Fenofibrate', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablet Route of administration: oral', 'armGroupLabels': ['Usual Care']}, {'name': 'Nicotinic acid', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablet Route of administration: oral', 'armGroupLabels': ['Usual Care']}, {'name': 'Omega-3 fatty acids', 'type': 'DRUG', 'description': 'Pharmaceutical form: tablet Route of administration: oral', 'armGroupLabels': ['Usual Care']}, {'name': 'Antihyperglycemic Drug', 'type': 'DRUG', 'description': 'Insulin (injectable or inhaled) or other antihyperglycemic drugs as clinically indicated.', 'armGroupLabels': ['Alirocumab 75 mg Q2W/Up to 150 mg Q2W', 'Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigational Site Number 840-163', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-141', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92648', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-152', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-115', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-118', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-106', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '93041', 'city': 'Port Hueneme', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-176', 'geoPoint': {'lat': 34.14778, 'lon': -119.19511}}, {'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-122', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '92780-6953', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-156', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '91405', 'city': 'Van Nuys', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840-160', 'geoPoint': {'lat': 34.18667, 'lon': -118.44897}}, {'zip': '33434', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840-107', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33472', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840-170', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '34201', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840-114', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840-132', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '32765', 'city': 'Oviedo', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840-179', 'geoPoint': {'lat': 28.67, 'lon': -81.20812}}, {'zip': '33634', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840-123', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '39819', 'city': 'Bainbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840-137', 'geoPoint': {'lat': 30.9038, 'lon': -84.57547}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840-128', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site Number 840-169', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Investigational Site Number 840-167', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840-161', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60012', 'city': 'Crystal Lake', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840-184', 'geoPoint': {'lat': 42.24113, 'lon': -88.3162}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840-174', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '62711', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840-138', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site Number 840-108', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '42003', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site Number 840-183', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigational Site Number 840-190', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site Number 840-151', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '65109', 'city': 'Jefferson City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 840-113', 'geoPoint': {'lat': 38.5767, 'lon': -92.17352}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 840-120', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68131-2137', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigational Site Number 840-148', 'geoPoint': {'lat': 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