Viewing Study NCT02756832

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Ignite Creation Date: 2025-12-24 @ 9:45 PM
Ignite Modification Date: 2026-03-05 @ 8:13 PM
Study NCT ID: NCT02756832
Status: COMPLETED
Last Update Posted: 2019-07-10
First Post: 2016-04-27
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: An Observational Study of Alogliptin Benzoate in Participants With Diabetes Mellitus Type 2
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug administration up to Month 6', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Alogliptin Benzoate', 'description': 'Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.', 'otherNumAtRisk': 1399, 'deathsNumAtRisk': 1399, 'otherNumAffected': 69, 'seriousNumAtRisk': 1399, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HbA1C increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Low density lipoprotein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'High density lipoprotein decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood creatine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyelonephritis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Autonomic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Disease risk factor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vulval cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1399, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin Benzoate', 'description': 'Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1392', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1314', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a diagnosis of diabetes mellitus type 2 (T2DM), newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1314', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin Benzoate', 'description': 'Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.'}], 'classes': [{'title': 'Prior Therapy Diabetes Mellitus (DM), No Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Prior Therapy DM, Monotherapy: Biguanides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '629', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Prior Therapy DM, Monotherapy: Sulfonylureas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Prior Therapy DM, Monotherapy: Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Prior Therapy DM, Biguanides+Sulfonylureas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Prior Therapy DM, Biguanides+SGLT2 inhibitors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Prior Therapy DM, Combined therapy: Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Sex, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Sex,Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '851', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Age Group, <58 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '588', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Age Group, ≥58 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '726', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Cardiovascular (CV) Risk Group, High CV Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'CV Risk Group, Very High CV Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Therapy Type (TT), Monotherapy: VIPIDIA®', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'TT, Combined: VIPIDIA®+Biguanides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '767', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'TT, Combined: VIPIDIA®+Sulfonylureas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'TT, Combined: VIPIDIA®+SGLT2 Inhibitors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'TT, Combined: VIPIDIA®+Biguanides+Sulfonylureas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'TT, Combined: VIPIDIA®+Biguanides+SGLT2 Inhibitors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'TT, Combined: VIPIDIA®+Biguanides+Antidiabetics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'TT,Combined: VIPIDIA®+Biguanide+Sulfonylurea+SGLT2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'BMI, Normal Weight (<25 kg/m^2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'BMI, Over-Weight (25≤BMI<30 kg/m^2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'BMI, Obesity Class I (30≤BMI<35 kg/m^2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'BMI, Obesity Class II (35≤BMI<40 kg/m^2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'BMI, Obesity Class III (BMI≥40 kg/m^2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Glycemic Control, HBA1C<7.5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Glycemic Control, 7.5%≥HBA1C<9%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '713', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Glycemic Control, HBA1C≥9%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'T2DM Duration, 0-3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'T2DM Duration, 3-5 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'T2DM Duration, 5-10 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'T2DM Duration, >=10 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control and T2DM duration. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Decrease in HbA1c Level by <7.0% at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin Benzoate', 'description': 'Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '49.2', 'upperLimit': '54.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Month 6', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Percentage of participants with a decrease of \\<7.0% from baseline in HbA1c were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c Level Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin Benzoate', 'description': 'Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1392', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1250', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Change from Month 3 to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Months 3 and 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Marked Hyperglycemia at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin Benzoate', 'description': 'Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3', 'description': 'Marked hyperglycemia is defined as fasting plasma glucose (FPG) higher than or equal to 11 mmol/L.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin Benzoate', 'description': 'Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1323', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1237', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Change from Month 3 to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1225', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1255', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'The change in the value of fasting plasma glucose value collected at Months 3 and 6 relative to baseline. Target FPG depended on the defined individual targets of glycemic control by HbA1c level ≤6.5 to 8.0 mmol/l. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weight Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin Benzoate', 'description': 'Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.6', 'spread': '16.5', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1377', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '3.0', 'groupId': 'OG000'}]}]}, {'title': 'Change from Month 3 to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1353', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1355', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '4.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3 and 6', 'description': "Change in the participant's weight was collected at Months 3 and 6 relative to baseline.", 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Postprandial Glycemia Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin Benzoate', 'description': 'Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '991', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.4', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '913', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Change from Month 3 to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '989', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '915', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'The change between the baseline (pre-prandial (before meal)) and postprandial (after meal) glucose values were collected at Months 3 and 6 relative to baseline.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin Benzoate', 'description': 'Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.'}], 'classes': [{'title': 'Total Cholesterol, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Total Cholesterol, Change from Baseline to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '849', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Total Cholesterol, Change from Month 3 to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '851', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Total Cholesterol, Change from Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '967', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '825', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Change from Baseline to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '556', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Change from Month 3 to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '613', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Change from Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '630', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Low Density Lipoproteins (LDL), Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '715', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'LDL, Change from Baseline to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'LDL, Change from Month 3 to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'LDL, Change from Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '525', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'High Density Lipoproteins (HDL), Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '666', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'HDL, Change from Baseline to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'HDL, Change from Month 3 to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'HDL, Change from Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '473', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'The change between the total cholesterol triglycerides, low density lipoproteins and high density lipoproteins values were collected at Months 3 and 6 relative to baseline.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Decrease in HbA1c Level by ≥0.3% at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin Benzoate', 'description': 'Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000', 'lowerLimit': '87.3', 'upperLimit': '90.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Month 6', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Percentage of participants with a decrease of ≥0.3% from baseline in HbA1c were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Used Healthcare Resources', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin Benzoate', 'description': 'Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.'}], 'classes': [{'title': 'Rate of Hospitalization', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.1'}]}]}, {'title': 'Rate of Emergency', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.5'}]}]}, {'title': 'Rate of Physician Office Visits', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.1'}]}]}, {'title': 'Rate of Other Type of Usage', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 6', 'description': 'Healthcare resources included rate of hospitalization, emergency, emergency room visits, physician office visits, and other type of usage.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alogliptin Benzoate', 'description': 'Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1409'}]}, {'type': 'Received Therapy', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1393'}]}, {'type': 'Included in Efficacy and Safety Analysis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1399'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1356'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Lost for Observation after Baseline', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Lost for Observation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': "Patient's Unwillingness", 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Insufficient Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Sponsor Decision/Regulatory Requirement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'Participants took part in the study in Russia from 20-Sep-2016 to 28-Apr-2018.', 'preAssignmentDetails': 'Participants with a diagnosis of diabetes mellitus type 2 (T2DM) prescribed alogliptin benzoate in accordance with Russian SmPC were enrolled in this observational study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1399', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Alogliptin Benzoate', 'description': 'Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '9.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '907', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '492', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'European', 'measurements': [{'value': '1375', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'African American or African', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'categories': [{'measurements': [{'value': '1399', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants with a diagnosis of diabetes mellitus type 2 (T2DM), newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-17', 'size': 1693961, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-15T14:32', 'hasProtocol': False}, {'date': '2018-12-19', 'size': 24258125, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-15T14:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1409}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2016-04-27', 'resultsFirstSubmitDate': '2019-04-15', 'studyFirstSubmitQcDate': '2016-04-27', 'lastUpdatePostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-09', 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics', 'timeFrame': 'Baseline and Month 6', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control and T2DM duration. A negative change from Baseline indicates improvement.'}, {'measure': 'Percentage of Participants With a Decrease in HbA1c Level by <7.0% at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Percentage of participants with a decrease of \\<7.0% from baseline in HbA1c were reported.'}, {'measure': 'Change From Baseline in HbA1c Level Over Time', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Months 3 and 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.'}, {'measure': 'Percentage of Participants With Marked Hyperglycemia at Month 3', 'timeFrame': 'Month 3', 'description': 'Marked hyperglycemia is defined as fasting plasma glucose (FPG) higher than or equal to 11 mmol/L.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'The change in the value of fasting plasma glucose value collected at Months 3 and 6 relative to baseline. Target FPG depended on the defined individual targets of glycemic control by HbA1c level ≤6.5 to 8.0 mmol/l. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Weight Over Time', 'timeFrame': 'Baseline, Months 3 and 6', 'description': "Change in the participant's weight was collected at Months 3 and 6 relative to baseline."}, {'measure': 'Change From Baseline in Postprandial Glycemia Over Time', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'The change between the baseline (pre-prandial (before meal)) and postprandial (after meal) glucose values were collected at Months 3 and 6 relative to baseline.'}, {'measure': 'Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'The change between the total cholesterol triglycerides, low density lipoproteins and high density lipoproteins values were collected at Months 3 and 6 relative to baseline.'}, {'measure': 'Percentage of Participants With a Decrease in HbA1c Level by ≥0.3% at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Percentage of participants with a decrease of ≥0.3% from baseline in HbA1c were reported.'}, {'measure': 'Percentage of Participants Who Used Healthcare Resources', 'timeFrame': 'Baseline up to Month 6', 'description': 'Healthcare resources included rate of hospitalization, emergency, emergency room visits, physician office visits, and other type of usage.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of alogliptin benzoate (VIPIDIA®) on glycosylated hemoglobin (HbA1c) level dynamics in participants with diabetes mellitus type 2 (T2DM) at Month 6.', 'detailedDescription': 'The drug being studied in this study is called alogliptin benzoate. Alogliptin benzoate is being researched to treat people who have T2DM. This study will look at the HbA1c level dynamics in participants with T2DM.\n\nThe study enrolled 1409 patients. Alogliptin benzoate will be prescribed by their physician in accordance with the Russian summary of product characteristics (SmPC).\n\nThis multi-center study will be conducted in the Russian Federation. The overall duration of study for observation will be approximately 6 months. Participants will make multiple visits to the clinic as assigned by each physician according to their routine practice, in every 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participants diagnosed with type 2 diabetes mellitus (T2DM) will be observed.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female participants ≥ 18 years of age;\n2. Has a diagnosis of type 2 diabetes mellitus (T2DM)\n3. Participants with:\n\n * newly diagnosed diabetes mellitus (DM) type 2 (drug naïve) or\n * inadequate glycemic control on previously prescribed any oral antidiabetic drug.\n4. VIPIDIA® is prescribed according to the approved label for the Russian Federation.\n5. The participant's physician decides to prescribe VIPIDIA®:\n\n * as monotherapy or\n * as a part of combination therapy.\n6. The participant (or, when applicable, the participant's legally acceptable representative) signs and dates a written, informed consent form prior to the start of data collection. Participant is capable of understanding the written informed consent, provides signed and written informed consent, and agrees to comply with protocol requirements. In case the participant is blind or unable to read, informed consent will also be witnessed.\n\nExclusion Criteria:\n\n1. Contraindications of respective approved Russian summary of product characteristics (SmPC);\n2. In the opinion of the physician, the participant has any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study;\n3. Had used Dipeptidyl peptidase-4 inhibitors (DPP-IV inhibitors) or Glucagon like peptide-1 agonists (aGLP-1) within the 3 months prior to the start of VIPIDIA® treatment.\n4. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress."}, 'identificationModule': {'nctId': 'NCT02756832', 'briefTitle': 'An Observational Study of Alogliptin Benzoate in Participants With Diabetes Mellitus Type 2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Local, Multicentre, Observational, Non-Interventional Prospective Study of Alogliptin Benzoate in Patients With Diabetes Mellitus Type 2', 'orgStudyIdInfo': {'id': 'Alogliptin-4018'}, 'secondaryIdInfos': [{'id': 'MACS-2015-101024', 'type': 'OTHER', 'domain': 'Takeda'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Alogliptin Benzoate', 'description': 'Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.', 'interventionNames': ['Drug: Alogliptin Benzoate']}], 'interventions': [{'name': 'Alogliptin Benzoate', 'type': 'DRUG', 'otherNames': ['VIPIDIA®'], 'description': 'Alogliptin benzoate tablets', 'armGroupLabels': ['Alogliptin Benzoate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '163001', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'First City Clinical Hospital named after E.E. Vlosevich', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '656019', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'City polyclinic #11', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '308007', 'city': 'Belgorod', 'country': 'Russia', 'facility': 'Belgorod Regional Clinical hospital named after Saint I Belgorod Regional Clinical Hospital of St. Joasaph', 'geoPoint': {'lat': 50.60343, 'lon': 36.58091}}, {'zip': '454091', 'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'LLC Medical center Lotos', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'zip': '454100', 'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Istochnik clinic', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'zip': '454138', 'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Regional clinical hospital #3', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'zip': '672038', 'city': 'Chita', 'country': 'Russia', 'facility': 'Medical center Health Academy', 'geoPoint': {'lat': 52.04311, 'lon': 113.49171}}, {'zip': '672090', 'city': 'Chita', 'country': 'Russia', 'facility': 'Chita State Medical Academy', 'geoPoint': {'lat': 52.04311, 'lon': 113.49171}}, {'zip': '420039', 'city': "Kazan'", 'country': 'Russia', 'facility': 'City polyclinic #11', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '420066', 'city': "Kazan'", 'country': 'Russia', 'facility': 'Ciry polyclinic #10', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '650066', 'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Kemerovo Regional Clinical Hospital named after S.V. Belyaev', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '680000', 'city': 'Khabarovsk', 'country': 'Russia', 'facility': 'Medical Center Clinic of Hormonal Health', 'geoPoint': {'lat': 48.46204, 'lon': 135.0971}}, {'zip': '680009', 'city': 'Khabarovsk', 'country': 'Russia', 'facility': 'Regional Clinical hospital named after S.I. Sergeev', 'geoPoint': {'lat': 48.46204, 'lon': 135.0971}}, {'zip': '68022', 'city': 'Khabarovsk', 'country': 'Russia', 'facility': 'Road Clinical Hospital at Khabarovsk Station - 1', 'geoPoint': {'lat': 48.46204, 'lon': 135.0971}}, {'zip': '610011', 'city': 'Kirov', 'country': 'Russia', 'facility': 'Northern Clinical Emergency Hospital', 'geoPoint': {'lat': 58.59809, 'lon': 49.65783}}, {'zip': '610030', 'city': 'Kirov', 'country': 'Russia', 'facility': 'Kirov Clinical Hospital #7 named after V.I. Yurlova', 'geoPoint': {'lat': 58.59809, 'lon': 49.65783}}, {'zip': '156005', 'city': 'Kostroma', 'country': 'Russia', 'facility': 'Kostroma City hospital', 'geoPoint': {'lat': 57.76638, 'lon': 40.92828}}, {'zip': '305007', 'city': 'Kursk', 'country': 'Russia', 'facility': 'Kursk Regional Clinical Hospital', 'geoPoint': {'lat': 51.72689, 'lon': 36.18457}}, {'zip': '141730', 'city': 'Lobnya', 'country': 'Russia', 'facility': 'Lobnya Central City Hospital', 'geoPoint': {'lat': 56.02714, 'lon': 37.46793}}, {'zip': '115551', 'city': 'Moscow', 'country': 'Russia', 'facility': 'City polyclinic #166', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '117036', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Endocrinology Research Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '117218', 'city': 'Moscow', 'country': 'Russia', 'facility': 'City polyclinic #22', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '117546', 'city': 'Moscow', 'country': 'Russia', 'facility': 'City polyclinic #52', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '121552', 'city': 'Moscow', 'country': 'Russia', 'facility': 'The Scientific Center of Cardiovascular Surgery named after A.N. Bakulev', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '123056', 'city': 'Moscow', 'country': 'Russia', 'facility': 'CJSC Medsi', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '127543', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Diagnostical Center #5', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '199435', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603006', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Clinical Diagnostical Center', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '603155', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'City polyclinic #3', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '630099', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Medical Center Healthy family LLC', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '185000', 'city': 'Petrozavodsk', 'country': 'Russia', 'facility': 'Republican Hospital named after V.A.Baranov', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'zip': '344022', 'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'Rostov State Medical University', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'zip': '390037', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'City Clinical hospital #11', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '125167', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City policlinic #117', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '192289', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City polyclinic #109', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194354', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Saint-Petersburg Territorial Diabetological Center', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '195299', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'City policlinic #86', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197183', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Consultative and diagnostic polyclinic 1 of Primorsky district', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443011', 'city': 'Samara', 'country': 'Russia', 'facility': 'Samara Regional Clinical Diagnostical polyclinic #14', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '443041', 'city': 'Samara', 'country': 'Russia', 'facility': 'LLC Center Diabet', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '443110', 'city': 'Samara', 'country': 'Russia', 'facility': 'City policlinic #9', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '410005', 'city': 'Saratov', 'country': 'Russia', 'facility': 'City polyclinic #22', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '634009', 'city': 'Tomsk', 'country': 'Russia', 'facility': 'City policlinic #3', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'zip': '634009', 'city': 'Tomsk', 'country': 'Russia', 'facility': 'LLC Medical center Ideale', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'zip': '634024', 'city': 'Tomsk', 'country': 'Russia', 'facility': 'City policlinic #3', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'zip': '634063', 'city': 'Tomsk', 'country': 'Russia', 'facility': 'Tomsk Regional Clinical Hospital', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'zip': '450099', 'city': 'Ufa', 'country': 'Russia', 'facility': 'City polyclinic #43', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'zip': '600023', 'city': 'Vladimir', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 56.13854, 'lon': 40.39976}}, {'zip': '400081', 'city': 'Volgograd', 'country': 'Russia', 'facility': 'Regional Clinical Hospital #1', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}, {'zip': '400131', 'city': 'Volgograd', 'country': 'Russia', 'facility': 'Volgograd State Medical University', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}, {'zip': '160019', 'city': 'Vologda', 'country': 'Russia', 'facility': 'LLC Zdorovye, Diabetes Center', 'geoPoint': {'lat': 59.2239, 'lon': 39.88398}}, {'zip': '394018', 'city': 'Voronezh', 'country': 'Russia', 'facility': 'Voronezh Regional Clinical Diagnostical center', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'zip': '620043', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Ural State Medical Academy', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}], 'overallOfficials': [{'name': 'Medical Director Clinical Science', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}