Viewing Study NCT00707993

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Ignite Creation Date: 2025-12-25 @ 1:11 AM
Ignite Modification Date: 2025-12-27 @ 3:23 AM
Study NCT ID: NCT00707993
Status: COMPLETED
Last Update Posted: 2013-05-24
First Post: 2008-06-27
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Taiwan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520853', 'term': 'alogliptin'}, {'id': 'D005913', 'term': 'Glipizide'}], 'ancestors': [{'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialregistry@tpna.com', 'phone': '800-778-2860', 'title': 'Sr. VP, Clinical Science', 'organization': 'Takeda Global Research and Development Center, Inc.'}, 'certainAgreement': {'otherDetails': 'No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug.', 'description': 'At each visit the investigator was 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 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.', 'otherNumAtRisk': 222, 'otherNumAffected': 103, 'seriousNumAtRisk': 222, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.', 'otherNumAtRisk': 219, 'otherNumAffected': 105, 'seriousNumAtRisk': 219, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Graft thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Postoperative fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Stress fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin at Week 52.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.067', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.05', 'ciUpperLimit': '0.13', 'groupDescription': 'Primary null hypothesis: the average Week 52 HbA1c change from Baseline for alogliptin is inferior to that for glipizide (1-sided 97.5% CI \\[alpha=0.025\\] compared to non-inferiority margin of 0.4%). If the primary null hypothesis was rejected (non-inferiority demonstrated), an additional comparison for statistical superiority of alogliptin was performed. The CI was re-evaluated; statistical superiority declared if the upper limit was \\< 0%.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, randomization schedule, and geographic region as class effects; baseline value for the endpoint as a continuous covariate.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52.', 'description': 'The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.', 'unitOfMeasure': 'percentage of Glycosylated Hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'Week 4 (n=175; n=148)', 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.047', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.051', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=180; n=161)', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.051', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.054', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=180; n=162)', 'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.053', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.055', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=180; n=162)', 'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.050', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '0.052', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 (n=180; n=162)', 'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.051', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.054', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=180; n=162)', 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.052', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.055', 'groupId': 'OG001'}]}]}, {'title': 'Week 34 (n=180; n=162)', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.056', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.059', 'groupId': 'OG001'}]}]}, {'title': 'Week 42 (n=180; n=162)', 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.062', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.065', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42.', '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 each week indicated including final visit relative to baseline.', 'unitOfMeasure': 'percentage of Glycosylated Hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Incidence of Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '26.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'On occurrence (up to 52 weeks).', 'description': 'Percentage of participants with at least one hypoglycemic episode during 52 week study.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentages based on the number of Safety Set participants in each treatment group.'}, {'type': 'SECONDARY', 'title': 'Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'Baseline to <Week 4', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 to <Week 8', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 to <Week 12', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 to <Week 16', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 to <Week 20', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 to <Week 26', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 to <Week 34', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 34 to <Week 42', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 42 to Week 52', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'On Occurrence (up to 52 weeks).', 'description': 'The number of participants with a fasting plasma glucose value ≥ to 200 mg per dL during the 52 week study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had at least 1 dose of study medication (full analysis set).'}, {'type': 'SECONDARY', 'title': 'Incidence of Hyperglycemic Rescue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'Week 2 to <Week 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 to <Week 8', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 to <Week 12', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 to <Week 16', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 to <Week 20', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 to <Week 26', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 to <Week 34', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 34 to <Week 42', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 42 to Week 52', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Overall', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'On Occurrence (up to 52 weeks).', 'description': 'The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 52 week study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had at least 1 dose of study medication (full analysis set). Participants who discontinued prior to Week 2 were excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'Week 2 (n=196; n=199)', 'categories': [{'measurements': [{'value': '-3.8', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=217; n=213)', 'categories': [{'measurements': [{'value': '-7.7', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '1.95', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=217; n=214)', 'categories': [{'measurements': [{'value': '-8.9', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '-8.7', 'spread': '1.77', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=217; n=214)', 'categories': [{'measurements': [{'value': '-10.2', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '-9.9', 'spread': '1.86', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=217; n=214)', 'categories': [{'measurements': [{'value': '-7.9', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '-11.4', 'spread': '1.86', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 (n=217; n=214)', 'categories': [{'measurements': [{'value': '-9.8', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '-8.7', 'spread': '1.79', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=217; n=214)', 'categories': [{'measurements': [{'value': '-7.9', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'Week 34 (n=217; n=214)', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '-5.7', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'Week 42 (n=217; n=214)', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '-7.4', 'spread': '2.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=217; n=214)', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '2.26', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52.', 'description': 'The change in the value of fasting plasma glucose collected at each week indicated including final visit relative to baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-hour Postprandial Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'Week 52 PPG level (n=109; n=93)', 'categories': [{'measurements': [{'value': '-5.80', 'spread': '5.530', 'groupId': 'OG000'}, {'value': '6.30', 'spread': '5.989', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 PPG excursion (n=109; n=93)', 'categories': [{'measurements': [{'value': '1.82', 'spread': '4.434', 'groupId': 'OG000'}, {'value': '7.17', 'spread': '4.804', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52.', 'description': 'The change in postprandial (after eating a meal) glucose levels at week 52 relative to baseline. Standard 2-hour postprandial glucose (PPG) tests performed following an overnight fast and evaluated right before and after a 120-minute (2-hour) timeframe relative to ingestion of a standard oral glucose drink.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had at least 1 dose of study medication (full analysis set).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Proinsulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'Week 12 (n=207; n=186)', 'categories': [{'measurements': [{'value': '-6.0', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=211; n=194)', 'categories': [{'measurements': [{'value': '-4.6', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.56', 'groupId': 'OG001'}]}]}, {'title': 'Week 42 (n=211; n=194)', 'categories': [{'measurements': [{'value': '-4.6', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=211; n=194)', 'categories': [{'measurements': [{'value': '-4.9', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.48', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change between the value of fasting proinsulin collected at each week indicated including final visit relative to baseline.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'Week 12 (n=207; n=188)', 'categories': [{'measurements': [{'value': '-2.36', 'spread': '0.673', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.707', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=210; n=194)', 'categories': [{'measurements': [{'value': '-0.41', 'spread': '1.548', 'groupId': 'OG000'}, {'value': '3.03', 'spread': '1.611', 'groupId': 'OG001'}]}]}, {'title': 'Week 42 (n=210; n=194)', 'categories': [{'measurements': [{'value': '-0.58', 'spread': '1.254', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '1.305', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=210; n=194)', 'categories': [{'measurements': [{'value': '-1.72', 'spread': '1.731', 'groupId': 'OG000'}, {'value': '3.15', 'spread': '1.801', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change between the value of insulin collected at each week indicated including final visit relative to baseline.', 'unitOfMeasure': 'mcIU/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Proinsulin/Insulin Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'Week 12 (n=206; n=185)', 'categories': [{'measurements': [{'value': '-0.288', 'spread': '0.1035', 'groupId': 'OG000'}, {'value': '0.053', 'spread': '0.1092', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=210; n=193)', 'categories': [{'measurements': [{'value': '-0.253', 'spread': '0.4333', 'groupId': 'OG000'}, {'value': '0.562', 'spread': '0.4520', 'groupId': 'OG001'}]}]}, {'title': 'Week 42 (n=210; n=193)', 'categories': [{'measurements': [{'value': '-0.289', 'spread': '0.1500', 'groupId': 'OG000'}, {'value': '0.183', 'spread': '0.1565', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=210; n=193)', 'categories': [{'measurements': [{'value': '-0.155', 'spread': '0.0899', 'groupId': 'OG000'}, {'value': '-0.057', 'spread': '0.0938', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change between the ratio value of proinsulin and insulin collected at each week indicated including final visit relative to baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Homeostasis Model Assessment of Beta Cell Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'Week 12 (n=203; n=184)', 'categories': [{'measurements': [{'value': '-6.104', 'spread': '8.3062', 'groupId': 'OG000'}, {'value': '30.081', 'spread': '8.7264', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=207; n=193)', 'categories': [{'measurements': [{'value': '-0.136', 'spread': '9.7088', 'groupId': 'OG000'}, {'value': '31.669', 'spread': '10.0562', 'groupId': 'OG001'}]}]}, {'title': 'Week 42 (n=207; n=193)', 'categories': [{'measurements': [{'value': '-5.571', 'spread': '7.1395', 'groupId': 'OG000'}, {'value': '16.004', 'spread': '7.3950', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=207; n=193)', 'categories': [{'measurements': [{'value': '-9.755', 'spread': '13.8868', 'groupId': 'OG000'}, {'value': '35.281', 'spread': '14.3836', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change between homeostasis model assessment of beta cell function collected at each week indicated including final visit relative to baseline. Homeostasis model assessment of beta cell function measures beta cell function, calculated by a constant (20) times insulin, divided by fasting plasma glucose minus a constant (3.5).', 'unitOfMeasure': 'percent score of beta cell function', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'Week 8 (n=213; n=200)', 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.118', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.122', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=215; n=203)', 'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.146', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=215; n=204)', 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.188', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.193', 'groupId': 'OG001'}]}]}, {'title': 'Week 42 (n=215; n=204)', 'categories': [{'measurements': [{'value': '-0.72', 'spread': '0.211', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.216', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=215; n=204)', 'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.227', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.233', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change in body weight measured at each week indicated including final visit from baseline.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Lipids (Total Cholesterol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'Week 8 (n=208; n=195)', 'categories': [{'measurements': [{'value': '-5.6', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '2.08', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=213; n=201)', 'categories': [{'measurements': [{'value': '-4.2', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '2.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=213; n=201)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.09', 'groupId': 'OG001'}]}]}, {'title': 'Week 42 (n=213; n=201)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=213; n=201)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.35', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change in total cholesterol measured at each week indicated including final visit from baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'Week 8 (n=206; n=193)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=212; n=201)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.48', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=212; n=201)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'Week 42 (n=212; n=201)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=212; n=201)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.51', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change in high-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'Week 8 (n=200; n=185)', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '1.76', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=208; n=195)', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '1.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=208; n=196)', 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.72', 'groupId': 'OG001'}]}]}, {'title': 'Week 42 (n=208; n=197)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.84', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=209; n=197)', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.88', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change in low-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Lipids (Triglycerides)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'Week 8 (n=208; n=195)', 'categories': [{'measurements': [{'value': '-12.8', 'spread': '5.04', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '5.20', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=213; n=201)', 'categories': [{'measurements': [{'value': '-15.5', 'spread': '5.72', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '5.89', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=213; n=201)', 'categories': [{'measurements': [{'value': '-16.3', 'spread': '4.74', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '4.88', 'groupId': 'OG001'}]}]}, {'title': 'Week 42 (n=213; n=201)', 'categories': [{'measurements': [{'value': '-12.6', 'spread': '5.01', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '5.16', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=213; n=201)', 'categories': [{'measurements': [{'value': '-13.2', 'spread': '5.27', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '5.42', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change in triglycerides measured at each week indicated including final visit from baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High Sensitivity C-reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'Week 12 (n=209; n=192)', 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.699', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.730', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=212; n=198)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.682', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.706', 'groupId': 'OG001'}]}]}, {'title': 'Week 42 (n=212; n=198)', 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.736', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.762', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=212; n=198)', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.656', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.679', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change between the high sensitivity C-reactive protein value collected at each week indicated including final visit from baseline.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Incidence of Subjects Achieving Glycosylated Hemoglobin <=7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'HbA1c ≤6.5%', 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c ≤7.0%', 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}, {'value': '45.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 52.', 'description': 'The percentage of participants with a value for the percentage of glycosylated hemoglobin (HbA1c; the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5 and 7.0% during the 52 week study.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Incidence of Glycosylated Hemoglobin Decrease From Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'classes': [{'title': 'Decrease from Baseline in HbA1c ≥0.5%', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}, {'value': '29.0', 'groupId': 'OG001'}]}]}, {'title': 'Decrease from Baseline in HbA1c ≥1.0%', 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}]}]}, {'title': 'Decrease from Baseline in HbA1c ≥1.5%', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Decrease from Baseline in HbA1c ≥2.0%', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 52.', 'description': 'The percentage of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5, 1.0, 1.5 and 2.0% during the 52 week study.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'FG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '219'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '94'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Hyperglycemic Rescue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants enrolled at 110 investigative sites in Hungary, India, Israel, Mexico, Peru, Poland, Romania, Russia, South Africa, the Ukraine and the United States from 25 June 2008 to 30 August 2010.', 'preAssignmentDetails': 'Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled in one of two, once-daily (QD) treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.'}, {'id': 'BG001', 'title': 'Glipizide 5 mg QD', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.1', 'spread': '4.42', 'groupId': 'BG000'}, {'value': '69.8', 'spread': '4.07', 'groupId': 'BG001'}, {'value': '69.9', 'spread': '4.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<75 years', 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}]}, {'title': '≥75 years', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '78.60', 'spread': '14.842', 'groupId': 'BG000'}, {'value': '78.81', 'spread': '15.239', 'groupId': 'BG001'}, {'value': '78.70', 'spread': '15.024', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.58', 'spread': '4.348', 'groupId': 'BG000'}, {'value': '30.02', 'spread': '4.459', 'groupId': 'BG001'}, {'value': '29.79', 'spread': '4.404', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diabetes duration', 'classes': [{'categories': [{'measurements': [{'value': '6.25', 'spread': '6.285', 'groupId': 'BG000'}, {'value': '5.94', 'spread': '6.276', 'groupId': 'BG001'}, {'value': '6.10', 'spread': '6.275', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glomerular Filtration Rate (GFR)', 'classes': [{'categories': [{'measurements': [{'value': '73.62', 'spread': '14.762', 'groupId': 'BG000'}, {'value': '72.89', 'spread': '15.524', 'groupId': 'BG001'}, {'value': '73.26', 'spread': '15.133', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Using the Modification of Diet in Renal Disease method.', 'unitOfMeasure': 'mL/min/1.73 m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking history', 'classes': [{'title': 'Never smoked', 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '328', 'groupId': 'BG002'}]}]}, {'title': 'Current smoker', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Ex-smoker', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 441}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-22', 'studyFirstSubmitDate': '2008-06-27', 'resultsFirstSubmitDate': '2013-02-17', 'studyFirstSubmitQcDate': '2008-06-27', 'lastUpdatePostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-22', 'studyFirstPostDateStruct': {'date': '2008-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin at Week 52.', 'timeFrame': 'Baseline and Week 52.', 'description': 'The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42.', '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 each week indicated including final visit relative to baseline.'}, {'measure': 'Incidence of Hypoglycemia', 'timeFrame': 'On occurrence (up to 52 weeks).', 'description': 'Percentage of participants with at least one hypoglycemic episode during 52 week study.'}, {'measure': 'Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL).', 'timeFrame': 'On Occurrence (up to 52 weeks).', 'description': 'The number of participants with a fasting plasma glucose value ≥ to 200 mg per dL during the 52 week study.'}, {'measure': 'Incidence of Hyperglycemic Rescue', 'timeFrame': 'On Occurrence (up to 52 weeks).', 'description': 'The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 52 week study.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose', 'timeFrame': 'Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52.', 'description': 'The change in the value of fasting plasma glucose collected at each week indicated including final visit relative to baseline.'}, {'measure': 'Change From Baseline in 2-hour Postprandial Glucose', 'timeFrame': 'Baseline and Week 52.', 'description': 'The change in postprandial (after eating a meal) glucose levels at week 52 relative to baseline. Standard 2-hour postprandial glucose (PPG) tests performed following an overnight fast and evaluated right before and after a 120-minute (2-hour) timeframe relative to ingestion of a standard oral glucose drink.'}, {'measure': 'Change From Baseline in Fasting Proinsulin', 'timeFrame': 'Baseline, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change between the value of fasting proinsulin collected at each week indicated including final visit relative to baseline.'}, {'measure': 'Change From Baseline in Insulin', 'timeFrame': 'Baseline, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change between the value of insulin collected at each week indicated including final visit relative to baseline.'}, {'measure': 'Change From Baseline in Proinsulin/Insulin Ratio', 'timeFrame': 'Baseline, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change between the ratio value of proinsulin and insulin collected at each week indicated including final visit relative to baseline.'}, {'measure': 'Homeostasis Model Assessment of Beta Cell Function', 'timeFrame': 'Baseline, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change between homeostasis model assessment of beta cell function collected at each week indicated including final visit relative to baseline. Homeostasis model assessment of beta cell function measures beta cell function, calculated by a constant (20) times insulin, divided by fasting plasma glucose minus a constant (3.5).'}, {'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change in body weight measured at each week indicated including final visit from baseline.'}, {'measure': 'Change From Baseline in Serum Lipids (Total Cholesterol)', 'timeFrame': 'Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change in total cholesterol measured at each week indicated including final visit from baseline.'}, {'measure': 'Change From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol)', 'timeFrame': 'Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change in high-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.'}, {'measure': 'Change From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol)', 'timeFrame': 'Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change in low-density lipoprotein cholesterol measured at each week indicated including final visit from baseline.'}, {'measure': 'Change From Baseline in Serum Lipids (Triglycerides)', 'timeFrame': 'Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change in triglycerides measured at each week indicated including final visit from baseline.'}, {'measure': 'Change From Baseline in High Sensitivity C-reactive Protein', 'timeFrame': 'Baseline, Week 12, Week 26, Week 42 and Week 52.', 'description': 'The change between the high sensitivity C-reactive protein value collected at each week indicated including final visit from baseline.'}, {'measure': 'Incidence of Subjects Achieving Glycosylated Hemoglobin <=7%', 'timeFrame': 'Baseline and Week 52.', 'description': 'The percentage of participants with a value for the percentage of glycosylated hemoglobin (HbA1c; the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5 and 7.0% during the 52 week study.'}, {'measure': 'Incidence of Glycosylated Hemoglobin Decrease From Baseline.', 'timeFrame': 'Baseline and Week 52.', 'description': 'The percentage of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5, 1.0, 1.5 and 2.0% during the 52 week study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glucose Metabolism Disorder', 'Dysmetabolic Syndrome', 'Type II Diabetes', 'Diabetes Mellitus', 'Lipoatrophic', 'Dyslipidemia', 'Drug Therapy'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), compared to glipizide in elderly diabetic patients who have not received treatment or are on a single oral medication.', 'detailedDescription': 'Type 2 diabetes is among the most common chronic condition in adults 65 years of age or older. A recent National Health and Nutrition Examination Survey reported that more than 20% of adults aged 65 years or older have diabetes. These individuals are often under-treated with respect to glucose-lowering medications, and their care is complicated by the extent of their clinical and functional status. Age-related changes in physiology, diabetes-associated illnesses and other illnesses (such as renal, cardiac, and hepatic insufficiency), as well as use of multiple medications make standard oral anti-hyperglycemic therapy and insulin use problematic. In addition, hypoglycemia is more common and severe in older rather than younger patients taking oral antidiabetic drugs which can precipitate serious events such as falls and hip fractures. While avoidance of hypoglycemia is paramount in elderly diabetic patients, many commonly used medications are associated with a substantial risk for hypoglycemia. New classes of drug which avoid such complications in the elderly population are of increasing interest as this population continues to expand.\n\nTakeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes.\n\nThis study will compare the effectiveness and safety of alogliptin with that of glipizide (a commonly used diabetes medication) in adults who are 65 to 90 years of age with Type 2 diabetes. Individuals who participate in this study will either have failed diet and exercise therapy alone during the 2 months before Screening, or will have been receiving a single oral antidiabetic medication without obtaining good blood glucose (sugar) control.\n\nEach participant will be required to commit to screening visits. Study participation is anticipated to be up to 59 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has a diagnosis of type 2 diabetes mellitus with either:\n\n * Failed diet and exercise therapy alone as demonstrated by inadequate glycemic control while receiving no antidiabetic treatment within the two months prior to Screening, or\n * Failed treatment with oral monotherapy alone (may include treatment with two or more antidiabetic agents if for less than 7 days) as demonstrated by inadequate glycemic control within the two months prior to Screening.\n* Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2.\n* If regularly using other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening.\n* Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.\n* Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.\n* No major illness or debility that in the investigator's opinion prohibits the participant from completing the study.\n\nExclusion Criteria:\n\n* Systolic blood pressure greater than or equal to 160 mm Hg and/or diastolic pressure greater than or equal to 100 mm Hg.\n* Hemoglobin less than or equal to 12 g/dL for males or less than or equal to 10 g/dL for females.\n* Alanine aminotransferase greater than or equal to 3 times the upper limit of normal.\n* Calculated creatinine clearance less than or equal to 50 mL/min.\n* Thyroid-stimulating hormone level outside of the normal range.\n* History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening.\n* History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.\n* History of treated diabetic gastroparesis, gastric banding, or gastric bypass surgery.\n* New York Heart Association Class III or IV heart failure regardless of therapy.\n* History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.\n* History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.\n* History of infection with Human Immunodeficiency Virus.\n* History of a psychiatric disorder that will affect the participant's ability to participate in the study.\n* History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.\n* History of alcohol or substance abuse within the 2 years prior to Screening.\n* History of treatment with any weight-loss drugs or oral or systemically injected glucocorticoids within the 3 months prior to Screening.\n* Receipt of any investigational drug within the 30 days prior to Screening.\n* Prior treatment in an investigational study of alogliptin.\n* Clinically significant medical abnormality or disease or clinically significant abnormal findings at Screening (other than type 2 diabetes) that, in the opinion of the investigator, should exclude the participant from the study.\n* Has donated more than 400 mL of blood within the 90 days preceding their participation in the study.\n* Has hypersensitivity or has had an anaphylactic reaction(s) to any DPP-4 inhibitor drug."}, 'identificationModule': {'nctId': 'NCT00707993', 'briefTitle': 'Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'SYR-322_303'}, 'secondaryIdInfos': [{'id': '2008-000959-10', 'type': 'REGISTRY', 'domain': 'EudraCT'}, {'id': 'U1111-1112-7905', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alogliptin 25 mg QD', 'interventionNames': ['Drug: Alogliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glipizide 5 mg QD', 'interventionNames': ['Drug: Glipizide']}], 'interventions': [{'name': 'Alogliptin', 'type': 'DRUG', 'otherNames': ['SYR110322', 'SYR-322'], 'description': 'Alogliptin 25 mg, tablets, orally, once daily and glipizide placebo matching tablets, orally, once daily for up to 52 weeks.', 'armGroupLabels': ['Alogliptin 25 mg QD']}, {'name': 'Glipizide', 'type': 'DRUG', 'otherNames': ['Glucotrol'], 'description': 'Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.', 'armGroupLabels': ['Glipizide 5 mg QD']}]}, 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'Centurion', 'country': 'South Africa', 'geoPoint': {'lat': -25.85891, 'lon': 28.18577}}, {'city': 'Durban', 'country': 'South Africa', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'city': 'Johannesburg', 'country': 'South Africa', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Port Elizabeth', 'country': 'South Africa', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'city': 'Pretoria', 'country': 'South Africa', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Donetsk', 'country': 'Ukraine', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}], 'overallOfficials': [{'name': 'VP Biological Sciences', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}