Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
Study NCT ID:
NCT00286494
Status:
COMPLETED
Last Update Posted:
2012-02-03
First Post:
2006-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain']}, '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': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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 (or 30 days for a serious event) after the last dose of double-blind drug.', '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': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.', 'otherNumAtRisk': 97, 'otherNumAffected': 38, 'seriousNumAtRisk': 97, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.', 'otherNumAtRisk': 198, 'otherNumAffected': 76, 'seriousNumAtRisk': 198, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.', 'otherNumAtRisk': 199, 'otherNumAffected': 79, 'seriousNumAtRisk': 199, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Serum sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '0.056', 'groupId': 'OG001'}, {'value': '-0.80', 'spread': '0.056', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '-0.28', 'pValueComment': 'A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'groupDescription': 'Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \\>=500 subjects had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \\>0.05 significance level and \\>=80% of subjects meeting per protocol criteria.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, treatment regimen and geographic region as class variables; baseline pioglitazone dose and baseline value for the endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '-0.41', 'pValueComment': 'A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'groupDescription': 'Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \\>=500 subjects had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \\>0.05 significance level and \\>=80% of subjects meeting per protocol criteria.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, treatment regimen and geographic region as class variables; baseline pioglitazone dose and baseline value for the endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26.', '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 week 26 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 one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (Week 4).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.042', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '-0.45', 'spread': '0.030', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '-0.16', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '-0.21', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4.', '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 week 4 and Glycosylated Hemoglobin collected at baseline.', 'unitOfMeasure': 'percentage of Glycosylated Hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (Week 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.061', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.042', 'groupId': 'OG001'}, {'value': '-0.73', 'spread': '0.042', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '-0.27', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '-0.40', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8.', '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 week 8 and Glycosylated Hemoglobin collected at baseline.', 'unitOfMeasure': 'percentage of Glycosylated Hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (Week 12).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '0.048', 'groupId': 'OG001'}, {'value': '-0.82', 'spread': '0.048', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '-0.30', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '-0.43', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12.', '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 week 12 and Glycosylated Hemoglobin collected at baseline.', 'unitOfMeasure': 'percentage of Glycosylated Hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (Week 16).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.076', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '0.053', 'groupId': 'OG001'}, {'value': '-0.84', 'spread': '0.053', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '-0.26', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '-0.40', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16.', '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 week 16 and Glycosylated Hemoglobin collected at baseline.', 'unitOfMeasure': 'percentage of Glycosylated Hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin (Week 20).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.078', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.055', 'groupId': 'OG001'}, {'value': '-0.82', 'spread': '0.055', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '-0.22', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '-0.36', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 20.', '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 week 20 and Glycosylated Hemoglobin collected at baseline.', 'unitOfMeasure': 'percentage of Glycosylated Hemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (Week 1).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.7', 'spread': '3.11', 'groupId': 'OG000'}, {'value': '-14.2', 'spread': '2.20', 'groupId': 'OG001'}, {'value': '-18.2', 'spread': '2.22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.4', 'ciLowerLimit': '-18.9', 'ciUpperLimit': '-3.9', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.5', 'ciLowerLimit': '-23.0', 'ciUpperLimit': '-8.0', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 1.', 'description': 'The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (Week 2).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.97', 'groupId': 'OG000'}, {'value': '-21.0', 'spread': '2.13', 'groupId': 'OG001'}, {'value': '-21.2', 'spread': '2.10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.2', 'ciLowerLimit': '-26.4', 'ciUpperLimit': '-11.9', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.4', 'ciLowerLimit': '-26.6', 'ciUpperLimit': '-12.3', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 2.', 'description': 'The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (Week 4).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '-23.7', 'spread': '2.04', 'groupId': 'OG001'}, {'value': '-26.0', 'spread': '2.02', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.6', 'ciLowerLimit': '-27.5', 'ciUpperLimit': '-13.6', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.0', 'ciLowerLimit': '-29.9', 'ciUpperLimit': '-16.0', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller "n" at earlier timepoints due to unavailable prior values to carry forward'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (Week 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.1', 'spread': '3.26', 'groupId': 'OG000'}, {'value': '-22.6', 'spread': '2.30', 'groupId': 'OG001'}, {'value': '-27.1', 'spread': '2.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.5', 'ciLowerLimit': '-24.4', 'ciUpperLimit': '-8.7', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.1', 'ciLowerLimit': '-28.9', 'ciUpperLimit': '-13.3', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (Week 12).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.9', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '-20.4', 'spread': '2.34', 'groupId': 'OG001'}, {'value': '-26.2', 'spread': '2.33', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.4', 'ciLowerLimit': '-18.5', 'ciUpperLimit': '-2.4', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.3', 'ciLowerLimit': '-24.3', 'ciUpperLimit': '-8.3', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (Week 16).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.3', 'spread': '3.71', 'groupId': 'OG000'}, {'value': '-18.3', 'spread': '2.61', 'groupId': 'OG001'}, {'value': '-22.8', 'spread': '2.60', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.0', 'ciLowerLimit': '-18.9', 'ciUpperLimit': '-1.0', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.4', 'ciLowerLimit': '-23.3', 'ciUpperLimit': '-5.5', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (Week 20).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.4', 'spread': '3.58', 'groupId': 'OG000'}, {'value': '-21.9', 'spread': '2.52', 'groupId': 'OG001'}, {'value': '-21.6', 'spread': '2.51', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.6', 'ciLowerLimit': '-24.2', 'ciUpperLimit': '-6.9', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.2', 'ciLowerLimit': '-23.8', 'ciUpperLimit': '-6.7', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (Week 26).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.7', 'spread': '3.81', 'groupId': 'OG000'}, {'value': '-19.7', 'spread': '2.68', 'groupId': 'OG001'}, {'value': '-19.9', 'spread': '2.67', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.9', 'ciLowerLimit': '-23.1', 'ciUpperLimit': '-4.8', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.1', 'ciLowerLimit': '-23.3', 'ciUpperLimit': '-5.0', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.271', 'ciLowerLimit': '0.147', 'ciUpperLimit': '0.499', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen, \\& baseline HbA1c.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.235', 'ciLowerLimit': '0.126', 'ciUpperLimit': '0.438', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen, \\& baseline HbA1c.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 Weeks.', 'description': 'The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set) and had at least 1 post-baseline FPG measurement.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Rescue.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.266', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.628', 'ciLowerLimit': '0.277', 'ciUpperLimit': '1.425', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \\& baseline HbA1c.', 'testedNonInferiority': False}, {'pValue': '0.315', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.658', 'ciLowerLimit': '0.292', 'ciUpperLimit': '1.487', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \\& baseline HbA1c.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '26 Weeks.', 'description': 'The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set)and at least 1 post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Proinsulin (Week 4).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '-5.6', 'spread': '1.25', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.4', 'ciLowerLimit': '-10.6', 'ciUpperLimit': '-2.1', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.023', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-9.1', 'ciUpperLimit': '-0.7', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Proinsulin (Week 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '-6.5', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '-3.7', 'spread': '1.19', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-8.3', 'ciUpperLimit': '-0.1', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.489', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '2.6', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Proinsulin (Week 12).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '1.32', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.068', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-8.8', 'ciUpperLimit': '0.3', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.056', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-8.9', 'ciUpperLimit': '0.1', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Proinsulin (Week 16).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '1.32', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.884', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '4.2', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.993', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '4.5', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Proinsulin (Week 20).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '-3.9', 'spread': '1.17', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.3', 'ciLowerLimit': '-9.4', 'ciUpperLimit': '-1.3', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.143', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.0', 'ciLowerLimit': '-7.0', 'ciUpperLimit': '1.0', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Proinsulin (Week 26).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '1.34', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '1.33', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.080', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.1', 'ciLowerLimit': '-8.6', 'ciUpperLimit': '0.5', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.782', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '3.9', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin (Week 4).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.694', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': '0.501', 'groupId': 'OG001'}, {'value': '-0.97', 'spread': '0.501', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.249', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.99', 'ciLowerLimit': '-2.68', 'ciUpperLimit': '0.70', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.303', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.88', 'ciLowerLimit': '-2.56', 'ciUpperLimit': '0.80', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the value of insulin collected at week 4 and insulin collected at baseline.', 'unitOfMeasure': 'mcIU/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin (Week 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.748', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.531', 'groupId': 'OG001'}, {'value': '0.21', 'spread': '0.522', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.478', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-2.46', 'ciUpperLimit': '1.15', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.674', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '-1.41', 'ciUpperLimit': '2.17', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the value of insulin collected at week 8 and insulin collected at baseline.', 'unitOfMeasure': 'mcIU/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin (Week 12).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '1.085', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.771', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '0.757', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.743', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '-2.18', 'ciUpperLimit': '3.06', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.662', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-3.18', 'ciUpperLimit': '2.02', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of insulin collected at week 12 and insulin collected at baseline.', 'unitOfMeasure': 'mcIU/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. 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Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin (Week 20).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.690', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.490', 'groupId': 'OG001'}, {'value': '-0.33', 'spread': '0.481', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.807', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-1.87', 'ciUpperLimit': '1.46', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.867', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-1.79', 'ciUpperLimit': '1.51', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the value of insulin collected at week 20 and insulin collected at baseline.', 'unitOfMeasure': 'mcIU/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. 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Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 4).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.006', 'spread': '0.0144', 'groupId': 'OG000'}, {'value': '-0.051', 'spread': '0.0104', 'groupId': 'OG001'}, {'value': '-0.053', 'spread': '0.0104', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.057', 'ciLowerLimit': '-0.092', 'ciUpperLimit': '-0.022', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.059', 'ciLowerLimit': '-0.093', 'ciUpperLimit': '-0.024', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. 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Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 12).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.017', 'spread': '0.0190', 'groupId': 'OG000'}, {'value': '-0.029', 'spread': '0.0135', 'groupId': 'OG001'}, {'value': '-0.040', 'spread': '0.0132', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.050', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.046', 'ciLowerLimit': '-0.092', 'ciUpperLimit': '0.000', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.057', 'ciLowerLimit': '-0.102', 'ciUpperLimit': '-0.012', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 16).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.015', 'spread': '0.0153', 'groupId': 'OG000'}, {'value': '-0.042', 'spread': '0.0109', 'groupId': 'OG001'}, {'value': '-0.045', 'spread': '0.0107', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.144', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.027', 'ciLowerLimit': '-0.064', 'ciUpperLimit': '0.009', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.105', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.030', 'ciLowerLimit': '-0.067', 'ciUpperLimit': '0.006', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 20).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.012', 'spread': '0.0168', 'groupId': 'OG000'}, {'value': '-0.047', 'spread': '0.0119', 'groupId': 'OG001'}, {'value': '-0.040', 'spread': '0.0117', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.059', 'ciLowerLimit': '-0.100', 'ciUpperLimit': '-0.019', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.051', 'ciLowerLimit': '-0.092', 'ciUpperLimit': '-0.011', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 26).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.015', 'spread': '0.0185', 'groupId': 'OG000'}, {'value': '-0.035', 'spread': '0.0131', 'groupId': 'OG001'}, {'value': '-0.022', 'spread': '0.0129', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.050', 'ciLowerLimit': '-0.095', 'ciUpperLimit': '-0.005', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.093', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.038', 'ciLowerLimit': '-0.082', 'ciUpperLimit': '0.006', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-peptide (Week 4).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '175', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.144', 'spread': '0.1108', 'groupId': 'OG000'}, {'value': '-0.156', 'spread': '0.0783', 'groupId': 'OG001'}, {'value': '-0.088', 'spread': '0.0794', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.928', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.012', 'ciLowerLimit': '-0.280', 'ciUpperLimit': '0.255', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.683', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.056', 'ciLowerLimit': '-0.212', 'ciUpperLimit': '0.324', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-peptide (Week 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.111', 'spread': '0.1127', 'groupId': 'OG000'}, {'value': '-0.117', 'spread': '0.0787', 'groupId': 'OG001'}, {'value': '0.023', 'spread': '0.0788', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.967', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.006', 'ciLowerLimit': '-0.277', 'ciUpperLimit': '0.265', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.327', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.135', 'ciLowerLimit': '-0.135', 'ciUpperLimit': '0.405', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-peptide (Week 12).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.017', 'spread': '0.1226', 'groupId': 'OG000'}, {'value': '-0.085', 'spread': '0.0856', 'groupId': 'OG001'}, {'value': '-0.067', 'spread': '0.0856', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.649', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.068', 'ciLowerLimit': '-0.363', 'ciUpperLimit': '0.226', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.735', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.051', 'ciLowerLimit': '-0.344', 'ciUpperLimit': '0.243', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-peptide (Week 16).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.290', 'spread': '0.1135', 'groupId': 'OG000'}, {'value': '-0.071', 'spread': '0.0793', 'groupId': 'OG001'}, {'value': '-0.052', 'spread': '0.0793', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.114', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.220', 'ciLowerLimit': '-0.053', 'ciUpperLimit': '0.492', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.086', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.238', 'ciLowerLimit': '-0.033', 'ciUpperLimit': '0.510', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-peptide (Week 20).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.255', 'spread': '0.1029', 'groupId': 'OG000'}, {'value': '-0.228', 'spread': '0.0718', 'groupId': 'OG001'}, {'value': '-0.123', 'spread': '0.0719', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.835', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.026', 'ciLowerLimit': '-0.221', 'ciUpperLimit': '0.273', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.296', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.131', 'ciLowerLimit': '-0.115', 'ciUpperLimit': '0.378', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-peptide (Week 26).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.356', 'spread': '0.1071', 'groupId': 'OG000'}, {'value': '-0.233', 'spread': '0.0748', 'groupId': 'OG001'}, {'value': '-0.133', 'spread': '0.0748', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.349', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.123', 'ciLowerLimit': '-0.134', 'ciUpperLimit': '0.380', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.089', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.223', 'ciLowerLimit': '-0.034', 'ciUpperLimit': '0.479', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.815', 'ciLowerLimit': '1.736', 'ciUpperLimit': '13.358', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. 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OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \\& baseline HbA1c.', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.196', 'ciLowerLimit': '1.806', 'ciUpperLimit': '14.950', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \\& baseline HbA1c.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number 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 1.5% during the 26 week study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.364', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.959', 'ciLowerLimit': '0.459', 'ciUpperLimit': '8.362', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \\& baseline HbA1c.', 'testedNonInferiority': False}, {'pValue': '0.146', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.849', 'ciLowerLimit': '0.696', 'ciUpperLimit': '11.672', 'estimateComment': "Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \\<1.0 indicates lower incidence compared to placebo.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \\& baseline HbA1c.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number 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 2.0% during the 26 week study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight (Week 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'spread': '0.228', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.160', 'groupId': 'OG001'}, {'value': '0.39', 'spread': '0.161', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.718', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.65', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose,baseline value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.906', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.58', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between Body Weight measured at week 8 and Body Weight measured at baseline.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight (Week 12).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.60', 'spread': '0.267', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.187', 'groupId': 'OG001'}, {'value': '0.64', 'spread': '0.188', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.672', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.78', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.922', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '0.67', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between Body Weight measured at week 12 and Body Weight measured at baseline.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight (Week 20).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.94', 'spread': '0.318', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.222', 'groupId': 'OG001'}, {'value': '0.93', 'spread': '0.224', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.607', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.96', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.985', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '0.76', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between Body Weight measured at week 20 and Body Weight measured at baseline.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight (Week 26).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'OG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.04', 'spread': '0.329', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '0.230', 'groupId': 'OG001'}, {'value': '1.09', 'spread': '0.232', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.294', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '1.22', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}, {'pValue': '0.900', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '0.84', 'pValueComment': 'No multiplicity adjustments.', 'estimateComment': 'Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'FG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'FG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '197'}, {'groupId': 'FG002', 'numSubjects': '199'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '153'}, {'groupId': 'FG002', 'numSubjects': '160'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Hyperglycemic rescue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants enrolled at 125 investigative sites in 13 countries from 24 February 2006 to 02 August 2007.', 'preAssignmentDetails': 'Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled in one of 3, once-daily (QD) treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}, {'value': '493', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'BG001', 'title': 'Alogliptin 12.5 mg QD', 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'BG002', 'title': 'Alogliptin 25 mg QD', 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}, {'value': '408', 'groupId': 'BG003'}]}]}, {'title': 'Between 65 and 74 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}, {'title': '≥75 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '206', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '287', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': 493}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-01', 'studyFirstSubmitDate': '2006-02-01', 'resultsFirstSubmitDate': '2011-06-08', 'studyFirstSubmitQcDate': '2006-02-01', 'lastUpdatePostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-23', 'studyFirstPostDateStruct': {'date': '2006-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.', 'timeFrame': 'Baseline and Week 26.', '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 week 26 or final visit and glycosylated hemoglobin collected at baseline.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 4).', 'timeFrame': 'Baseline and Week 4.', '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 week 4 and Glycosylated Hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 8).', 'timeFrame': 'Baseline and Week 8.', '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 week 8 and Glycosylated Hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 12).', 'timeFrame': 'Baseline and Week 12.', '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 week 12 and Glycosylated Hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 16).', 'timeFrame': 'Baseline and Week 16.', '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 week 16 and Glycosylated Hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin (Week 20).', 'timeFrame': 'Baseline and Week 20.', '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 week 20 and Glycosylated Hemoglobin collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (Week 1).', 'timeFrame': 'Baseline and Week 1.', 'description': 'The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (Week 2).', 'timeFrame': 'Baseline and Week 2.', 'description': 'The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (Week 4).', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (Week 16).', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (Week 20).', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (Week 26).', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.'}, {'measure': 'Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).', 'timeFrame': '26 Weeks.', 'description': 'The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.'}, {'measure': 'Number of Participants Requiring Rescue.', 'timeFrame': '26 Weeks.', 'description': 'The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.'}, {'measure': 'Change From Baseline in Fasting Proinsulin (Week 4).', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Proinsulin (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Proinsulin (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Proinsulin (Week 16).', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Proinsulin (Week 20).', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.'}, {'measure': 'Change From Baseline in Fasting Proinsulin (Week 26).', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.'}, {'measure': 'Change From Baseline in Insulin (Week 4).', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the value of insulin collected at week 4 and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Insulin (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the value of insulin collected at week 8 and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Insulin (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of insulin collected at week 12 and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Insulin (Week 16).', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the value of insulin collected at week 16 and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Insulin (Week 20).', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the value of insulin collected at week 20 and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Insulin (Week 26).', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the value of insulin collected at week 26 and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 4).', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 16).', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 20).', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.'}, {'measure': 'Change From Baseline in Proinsulin/Insulin Ratio (Week 26).', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.'}, {'measure': 'Change From Baseline in C-peptide (Week 4).', 'timeFrame': 'Baseline and Week 4.', 'description': 'The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.'}, {'measure': 'Change From Baseline in C-peptide (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.'}, {'measure': 'Change From Baseline in C-peptide (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.'}, {'measure': 'Change From Baseline in C-peptide (Week 16).', 'timeFrame': 'Baseline and Week 16.', 'description': 'The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.'}, {'measure': 'Change From Baseline in C-peptide (Week 20).', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.'}, {'measure': 'Change From Baseline in C-peptide (Week 26).', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.'}, {'measure': 'Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.'}, {'measure': 'Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a value for the percentage of glycosylated hemoglobin less (the percentage of hemoglobin that is bound to glucose) than or equal to 7.0% during the 26 week study.'}, {'measure': 'Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.'}, {'measure': 'Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number 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% during the 26 week study.'}, {'measure': 'Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number 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 1.0% during the 26 week study.'}, {'measure': 'Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number 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 1.5% during the 26 week study.'}, {'measure': 'Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.', 'timeFrame': 'Baseline and Week 26.', 'description': 'The number 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 2.0% during the 26 week study.'}, {'measure': 'Change From Baseline in Body Weight (Week 8).', 'timeFrame': 'Baseline and Week 8.', 'description': 'The change between Body Weight measured at week 8 and Body Weight measured at baseline.'}, {'measure': 'Change From Baseline in Body Weight (Week 12).', 'timeFrame': 'Baseline and Week 12.', 'description': 'The change between Body Weight measured at week 12 and Body Weight measured at baseline.'}, {'measure': 'Change From Baseline in Body Weight (Week 20).', 'timeFrame': 'Baseline and Week 20.', 'description': 'The change between Body Weight measured at week 20 and Body Weight measured at baseline.'}, {'measure': 'Change From Baseline in Body Weight (Week 26).', 'timeFrame': 'Baseline and Week 26.', 'description': 'The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glucose Metabolism Disorder', 'Dysmetabolic Syndrome', 'Type II Diabetes', 'Diabetes Mellitus', 'Lipoatrophic', 'Dyslipidemia', 'Drug Therapy'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '19650752', 'type': 'RESULT', 'citation': 'Pratley RE, Reusch JE, Fleck PR, Wilson CA, Mekki Q; Alogliptin Study 009 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin. 2009 Oct;25(10):2361-71. doi: 10.1185/03007990903156111.'}, {'pmid': '19793357', 'type': 'RESULT', 'citation': 'Pratley RE, McCall T, Fleck PR, Wilson CA, Mekki Q. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc. 2009 Nov;57(11):2011-9. doi: 10.1111/j.1532-5415.2009.02484.x. Epub 2009 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with pioglitazone in adults with type 2 diabetes mellitus', 'detailedDescription': 'There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected.\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\nThe aim of the current study is to evaluate the efficacy of alogliptin in combination with pioglitazone in subjects who are inadequately controlled on a thiazolidinedione (pioglitazone or rosiglitazone) alone or in combination with metformin or a sulfonylurea. Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Diagnosis of type 2 diabetes mellitus currently treated with a thiazolidinedione either alone or in combination with metformin or a sulfonylurea but who are experiencing inadequate glycemic control. The subject should have received the thiazolidinedione therapy (rosiglitazone or pioglitazone) either alone or in combination with metformin or a sulfonylurea for at least the 3 months prior to Screening and must have been on a stable dose for all their antidiabetic treatments for at least the month prior to Screening.\n* No treatment with antidiabetic agents other than a thiazolidinedione alone or in combination with either metformin or a sulfonylurea within the 3 months prior to Screening. (Exception: if a subject has received other antidiabetic therapy for less than 7 days within the 3 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* Fasting C-peptide concentration greater than or equal to 0.8 ng per mL. (If this screening criterion is not met, the subject still qualifies if C-peptide is greater than or equal to 1.5 ng per mL after a challenge test.)\n* Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive.\n* If regular use of other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator.\n* Systolic blood pressure less than or equal to 180 mm Hg and diastolic pressure less than or equal to 110 mm Hg.\n* Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal to10 g per dL for females.\n* Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal.\n* Serum creatinine less than or equal to 2.0 mg per dL.\n* Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid.\n* Neither pregnant nor lactating.\n* Female subjects of childbearing potential must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in 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 subject from completing the study.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria\n\n* Urine albumin to creatinine ratio of greater than 1000 μg per mg at Screening. If elevated, the subject may be rescreened within 1 week.\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. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.)\n* History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.\n* History of treated diabetic gastric paresis.\n* New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at Class I or II are candidates for the study.\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 hepatitis B, hepatitis C, or human immunodeficiency virus.\n* History of a psychiatric disorder that will affect the subject'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* Receipt of any investigational drug within the 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within the 3 months prior to Screening.\n* Prior treatment in an investigational study of alogliptin.\n* Excluded Medications:\n\n * Treatment with antidiabetic agents other than a thiazolidinedione alone or in combination with either metformin or a sulfonylurea is not allowed within the 3 months prior to Screening and through the completion of the end-of-treatment/early termination procedures.\n * Treatment with weight-loss drugs, any investigational antidiabetics, or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of-treatment/early termination procedures. Inhaled corticosteroids are allowed.\n\nSubjects must not take any medications, including over-the-counter products, without first consulting with the investigator."}, 'identificationModule': {'nctId': 'NCT00286494', 'briefTitle': 'Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With Pioglitazone in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'SYR-322-TZD-009'}, 'secondaryIdInfos': [{'id': '2005-004669-40', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1113-8552', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Pioglitazone']}, {'type': 'EXPERIMENTAL', 'label': 'Alogliptin 12.5 mg QD', 'interventionNames': ['Drug: Alogliptin and pioglitazone']}, {'type': 'EXPERIMENTAL', 'label': 'Alogliptin 25 mg QD', 'interventionNames': ['Drug: Alogliptin and pioglitazone']}], 'interventions': [{'name': 'Alogliptin and pioglitazone', 'type': 'DRUG', 'otherNames': ['SYR110322', 'Alogliptin', 'AD-4833', 'Pioglitazone', 'Actos', 'SYR-322'], 'description': 'Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks', 'armGroupLabels': ['Alogliptin 12.5 mg QD']}, {'name': 'Alogliptin and pioglitazone', 'type': 'DRUG', 'otherNames': ['SYR110322', 'Alogliptin', 'AD-4833', 'Pioglitazone', 'Actos', 'SYR-322'], 'description': 'Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks', 'armGroupLabels': ['Alogliptin 25 mg QD']}, {'name': 'Pioglitazone', 'type': 'DRUG', 'otherNames': ['AD-4833', 'Actos'], 'description': 'Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Artesia', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.86585, 'lon': -118.08312}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'city': 'Northridge', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 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'Multiple Cities', 'country': 'Argentina'}, {'city': 'Multiple Cities', 'country': 'Australia'}, {'city': 'Multiple Cities', 'country': 'Brazil'}, {'city': 'Multiple Cities', 'country': 'Czechia'}, {'city': 'Multiple Cities', 'country': 'Germany'}, {'city': 'Multiple Cities', 'country': 'Guatemala'}, {'city': 'Multiple Cities', 'country': 'Hungary'}, {'city': 'Multiple Cities', 'country': 'India'}, {'city': 'Multiple Cities', 'country': 'Mexico'}, {'city': 'Multiple Cities', 'country': 'Netherlands'}, {'city': 'Multiple Cities', 'country': 'New Zealand'}, {'city': 'Multiple Cities', 'country': 'Peru'}, {'city': 'Multiple Cities', 'country': 'South Africa'}], 'overallOfficials': [{'name': 'VP Biological Sciences', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}