Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01490918
Status:
COMPLETED
Last Update Posted:
2020-08-17
First Post:
2011-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020909', 'term': 'Acarbose'}, {'id': 'D000068899', 'term': 'Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D014312', 'term': 'Trisaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'choiyh@catholic.ac.kr', 'phone': '82-2-2258-8288', 'title': 'Yoon Hee Choi', 'organization': "The Catholic University of Korea, Seoul St Mary's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Evaluation of GIP and oxidative stress markers (8-OHdG, Nitrotyrosin) were not analyzed due to limited number of sample and technical problems leading to uninterpretable data.'}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'description': 'total number afffected by any other adverse event : included SAEs', 'eventGroups': [{'id': 'EG000', 'title': 'Acarbose Placebo, Metformin, Sitagliptin', 'description': 'The dose of Acarbose should be 50mg b.i.d, 50mg t.i.d and 100mg t.i.d at the 18th week, the 20th week and the 24th week respectively. The Acarbose placebo should be changed into real Acarbose from the 16th week.\n\nAcarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 14, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Sitagliptin, Metformin, Acarbose', 'description': "The group's drugs not include placebo. (Metformin, Sitagliptin, Acarbose)\n\nAcarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively", 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 19, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Metformin Placebo, Sitagliptin, Acarbose', 'description': 'The Metformin placebo should be changed into real Metformin from the 16th week.\n\nAcarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 11, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'large intestinal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'toothcache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'ALT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'AST increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'diabetes mellitus inadequate controll', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'uterine leimyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'prorteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'vitiligo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'seriousEvents': [{'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Change of Glycated Hemoglogin(HbA1c) From Baseline to 16 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Metformin+Sitagliptin', 'description': 'Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin'}, {'id': 'OG001', 'title': 'Sitagliptin+Metformin+Acarbose', 'description': 'Metformin and sitagliptin and acarbose treatment for 24 weeks.'}, {'id': 'OG002', 'title': 'Placebo+Sitagliptin+Acarbose', 'description': 'Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '0.84', 'spread': '0.21', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0036', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The threshold for statistical significance was p=0.05', 'groupDescription': 'primary outcome efficacy will be evaluated between group 1(placebo + metfromin + sitagliptin) and 2 (sitagliptine + metformin + acarbose)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baselin HbA1c as covariate'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 16 weeks', 'description': 'The change of glycated hemoglogin(HbA1c) from baseline to 16 weeks of treatment between Placebo + Metformin+Sitagliptin and Metformin + Sitagliptin + Acarbose group', 'unitOfMeasure': '% of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: intention to treatment, All subject randomized to each treatment group'}, {'type': 'SECONDARY', 'title': 'The Change of HbA1c From Baseline to 24 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Metformin+Sitagliptin', 'description': 'Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin'}, {'id': 'OG001', 'title': 'Sitagliptin+Metformin+Acarbose', 'description': 'Metformin and sitagliptin and acarbose treatment for 24 weeks.'}, {'id': 'OG002', 'title': 'Placebo+Sitagliptin+Acarbose', 'description': 'Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '0.23', 'spread': '1.32', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'The threshold for statistical significance was p=0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline HbA1c as covariate'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 24 weeks', 'description': 'The change of glycated hemoglogin(HbA1c) from baseline to 24 weeks of treatment between 3 groups', 'unitOfMeasure': '% of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: intention to treatment, All subject randomized to each treatment group'}, {'type': 'SECONDARY', 'title': 'The Change of PPG2hr From Baseline to 24 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Metformin+Sitagliptin', 'description': 'Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks.'}, {'id': 'OG001', 'title': 'Sitagliptin+Metformin+Acarbose', 'description': 'Metformin and sitagliptin and acarbose treatment for 24 weeks.'}, {'id': 'OG002', 'title': 'Placebo+Sitagliptin+Acarbose', 'description': 'Placebo and sitagliptin and acarbose treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks. The Metformin placebo should be changed into real Metformin from the 16th week.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.73', 'spread': '3.38', 'groupId': 'OG000'}, {'value': '-1.76', 'spread': '3.53', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '4.53', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0185', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'The threshold for statistical significance was p=0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'baseline PPG2hr as covariate'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 24 weeks', 'description': 'The change of PPG2hr (post prandia blood glucose 2hr from baseline to 24 weeks of treatment between 3 groups', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: intention to treatment, All subject randomized to each treatment group'}, {'type': 'SECONDARY', 'title': 'Changes in Glucose During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Metformin+Sitagliptin', 'description': 'Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks.'}, {'id': 'OG001', 'title': 'Sitagliptin+Metformin+Acarbose', 'description': 'Metformin and sitagliptin and acarbose treatment for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.85', 'spread': '2168.64', 'groupId': 'OG000'}, {'value': '-743.08', 'spread': '1278.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0356', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The threshold for statistical significance was p=0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'baseline data as covariate'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2(baseline) and Visit 5(16W)', 'description': 'Change of AUC(area under the curve) of glucose at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)', 'unitOfMeasure': 'mg min/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Insulin During Mixed Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Metformin+Sitagliptin', 'description': 'Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks.'}, {'id': 'OG001', 'title': 'Sitagliptin+Metformin+Acarbose', 'description': 'Metformin and sitagliptin and acarbose treatment for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '647.65', 'spread': '3854.75', 'groupId': 'OG000'}, {'value': '221.42', 'spread': '8339.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8258', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The threshold for statistical significance was p=0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'baseline data as covariate'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2(baseline) and Visit 5(16W)', 'description': 'Change of AUC(area under the curve) of insulin at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)', 'unitOfMeasure': 'pg min/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Active GLP-1 at 0 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Metformin+Sitagliptin', 'description': 'Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks.'}, {'id': 'OG001', 'title': 'Sitagliptin+Metformin+Acarbose', 'description': 'Metformin and sitagliptin and acarbose treatment for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.55', 'spread': '19.01', 'groupId': 'OG000'}, {'value': '-9.33', 'spread': '31.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9217', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The threshold for statistical significance was p=0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'baseline data as covariate'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 16 week', 'description': 'Change of active GLP-1 at 0 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2)', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Active GLP-1 at 120 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Metformin+Sitagliptin', 'description': 'Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks.'}, {'id': 'OG001', 'title': 'Sitagliptin+Metformin+Acarbose', 'description': 'Metformin and sitagliptin and acarbose treatment for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.92', 'spread': '21.78', 'groupId': 'OG000'}, {'value': '-23.36', 'spread': '33.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The threshold for statistical significance was p=0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'baseline data as covariate'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 16 week', 'description': 'Change of active GLP-1 at 120 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2)', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Glucagon During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Metformin+Sitagliptin', 'description': 'Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks.'}, {'id': 'OG001', 'title': 'Sitagliptin+Metformin+Acarbose', 'description': 'Metformin and sitagliptin and acarbose treatment for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-79.22', 'spread': '833.59', 'groupId': 'OG000'}, {'value': '-1411.79', 'spread': '1049.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The threshold for statistical significance was p=0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'baseline data as covariate'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2(baseline) and Visit 5(16W)', 'description': 'Change of AUC(area under the curve) of glucagon at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)', 'unitOfMeasure': 'min pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Mean Glucose During CGMS Between 3 Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Metformin+Sitagliptin', 'description': 'Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin'}, {'id': 'OG001', 'title': 'Sitagliptin+Metformin+Acarbose', 'description': 'Metformin and sitagliptin and acarbose treatment for 24 weeks.'}, {'id': 'OG002', 'title': 'Placebo + Sitagliptin + Acarbose', 'description': 'Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.91', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '3.22', 'spread': '1.25', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.292', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'The threshold for statistical significance was p=0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'baseline data as covariate'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2(baseline) and Visit 5(16W)', 'description': 'Change of mean glucose of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 3 groups', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Variation of Glucose During CGMS Between 3 Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Metformin+Sitagliptin', 'description': 'Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin'}, {'id': 'OG001', 'title': 'Sitagliptin+Metformin+Acarbose', 'description': 'Metformin and sitagliptin and acarbose treatment for 24 weeks.'}, {'id': 'OG002', 'title': 'Placebo + Acarbose + Sitagliptin', 'description': 'Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.33', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.314', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'The threshold for statistical significance was p=0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'baseline data as covariate'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2(baseline) and Visit 5(16W)', 'description': 'Change of standard deviation of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 3 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin vs placebo + acarbose + sitagliptin)', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in MAGE of Glucose During CGMS Between 2 Group(Group 1 vs Group 2),', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo+Metformin+Sitagliptin', 'description': 'Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin'}, {'id': 'OG001', 'title': 'Sitagliptin+Metformin+Acarbose', 'description': 'Metformin and sitagliptin and acarbose treatment for 24 weeks.'}, {'id': 'OG002', 'title': 'Placebo + Acarbose + Sitagliptin', 'description': 'Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.79', 'spread': '15.01', 'groupId': 'OG000'}, {'value': '-18.5', 'spread': '13.23', 'groupId': 'OG001'}, {'value': '2.72', 'spread': '2.72', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.7563', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'The threshold for statistical significance was p=0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'baseline data as covariate'}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2(baseline) and Visit 5(16W)', 'description': 'Change of mean amplitude of glycemic excursion of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acarbose Placebo, Metformin, Sitagliptin', 'description': 'Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks.'}, {'id': 'FG001', 'title': 'Sitagliptin, Metformin, Acarbose', 'description': 'Metformin and sitagliptin and acarbose treatment for 24 weeks.'}, {'id': 'FG002', 'title': 'Metformin Placebo, Sitagliptin, Acarbose', 'description': 'Placebo and sitagliptin and acarbose treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks. The Metformin placebo should be changed into real Metformin from the 16th week.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'other cause', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '165', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Acarbose Placebo, Metformin, Sitagliptin', 'description': 'The dose of Acarbose should be 50mg b.i.d, 50mg t.i.d and 100mg t.i.d at the 18th week, the 20th week and the 24th week respectively. The Acarbose placebo should be changed into real Acarbose from the 16th week.\n\nAcarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively'}, {'id': 'BG001', 'title': 'Sitagliptin, Metformin, Acarbose', 'description': "The group's drugs not include placebo. (Metformin, Sitagliptin, Acarbose)\n\nAcarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively"}, {'id': 'BG002', 'title': 'Metformin Placebo, Sitagliptin, Acarbose', 'description': 'The Metformin placebo should be changed into real Metformin from the 16th week.\n\nAcarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.55', 'spread': '10.51', 'groupId': 'BG000'}, {'value': '60.89', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '60.15', 'spread': '9.92', 'groupId': 'BG002'}, {'value': '59.03', 'spread': '9.88', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '165', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'placebo medication'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-31', 'studyFirstSubmitDate': '2011-12-09', 'resultsFirstSubmitDate': '2019-02-07', 'studyFirstSubmitQcDate': '2011-12-11', 'lastUpdatePostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-31', 'studyFirstPostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in Mean Glucose During CGMS Between 3 Group', 'timeFrame': 'Visit 2(baseline) and Visit 5(16W)', 'description': 'Change of mean glucose of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 3 groups'}, {'measure': 'Changes in Variation of Glucose During CGMS Between 3 Group', 'timeFrame': 'Visit 2(baseline) and Visit 5(16W)', 'description': 'Change of standard deviation of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 3 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin vs placebo + acarbose + sitagliptin)'}, {'measure': 'Changes in MAGE of Glucose During CGMS Between 2 Group(Group 1 vs Group 2),', 'timeFrame': 'Visit 2(baseline) and Visit 5(16W)', 'description': 'Change of mean amplitude of glycemic excursion of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)'}], 'primaryOutcomes': [{'measure': 'The Change of Glycated Hemoglogin(HbA1c) From Baseline to 16 Weeks of Treatment', 'timeFrame': 'baseline, 16 weeks', 'description': 'The change of glycated hemoglogin(HbA1c) from baseline to 16 weeks of treatment between Placebo + Metformin+Sitagliptin and Metformin + Sitagliptin + Acarbose group'}], 'secondaryOutcomes': [{'measure': 'The Change of HbA1c From Baseline to 24 Weeks of Treatment', 'timeFrame': 'baseline, 24 weeks', 'description': 'The change of glycated hemoglogin(HbA1c) from baseline to 24 weeks of treatment between 3 groups'}, {'measure': 'The Change of PPG2hr From Baseline to 24 Weeks of Treatment', 'timeFrame': 'baseline, 24 weeks', 'description': 'The change of PPG2hr (post prandia blood glucose 2hr from baseline to 24 weeks of treatment between 3 groups'}, {'measure': 'Changes in Glucose During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),', 'timeFrame': 'Visit 2(baseline) and Visit 5(16W)', 'description': 'Change of AUC(area under the curve) of glucose at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)'}, {'measure': 'Changes in Insulin During Mixed Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),', 'timeFrame': 'Visit 2(baseline) and Visit 5(16W)', 'description': 'Change of AUC(area under the curve) of insulin at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)'}, {'measure': 'Change in Active GLP-1 at 0 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2)', 'timeFrame': 'baseline, 16 week', 'description': 'Change of active GLP-1 at 0 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2)'}, {'measure': 'Change in Active GLP-1 at 120 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2)', 'timeFrame': 'baseline, 16 week', 'description': 'Change of active GLP-1 at 120 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2)'}, {'measure': 'Changes in Glucagon During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),', 'timeFrame': 'Visit 2(baseline) and Visit 5(16W)', 'description': 'Change of AUC(area under the curve) of glucagon at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acarbose', 'ACADEMIC'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Primary objective To evaluate the efficacy of Acarbose add-on therapy on glucose control in subjects with type 2 diabetes inadequately controlled with Metformin and Sitagliptin combination therapy.\n\nThe effect of acarbose, an alpha glucosidase inhibitor as a third-line therapeutic medication in subject who are inadequately controlled with metformin and DPP4 inhibitor will be evaluated with multicenter, randomized, 24-week, double blinded, placebo-controlled study in Korea.', 'detailedDescription': 'Eligible subjects will be assigned among 3 groups randomly at a ration of 2:2:1 to the following groups and primary efficacy variable analyzed at week 16.\n\ngroup 1 : acarbose placebo + metformin + sitagliptin (with switching placebo to acarbose qt week 16) group 2 : acarbose + metformin + sitagliptin group 3 : acarbose + metformin placebo + sitagliptin (with switching placebo to metformin at week 16)\n\nAfter 16 week of treatment, all subjects in 3 groups will be treated as triple combination of acarbose + metformin + sitagliptin, and diabetes related variables be collected and analyzed.\n\n1. Primary Endpoint Changes in HbA1c (hemoglobin A1c) at 16 week from baseline between group1 vs grou2\n2. Secondary Endpoints (1) Changes of HbA1c at 24 week between 3 groups (2) Changed of post-prandial blood glucose at 2 hour (ppg2h) at 16, 24 week\n\nfor exploratory purpose, following data will be collected and analyzed\n\n1. continuous glucose monitoring system (CGMS) data among selected subjects in 3 groups\n2. mixed meal tolerance test in only available institution. (glucose, insulin, GLP-1, GIP, glucagon ) among selected subjects in group 1 and group 2\n3. oxidative stress markers (8-OHdG, nitrotyrosin, CML)\n4. self monitoring of blood glucose'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects with type-II diabetes mellitus;\n2. Subjects aged between 20 and 80;\n3. Subjects whose HbA1c ratio is between 7.0% and 10.0%;\n4. Subjects who took Metformin and Sitagliptin for at least 12 weeks;\n5. Subjects who were given the explanation about this clinical study and signed the consent form.\n\nExclusion Criteria:\n\n1. Subjects who have taken drugs that are likely to affect blood glucose or who need to take such drugs, e.g., glucocorticoid;\n2. Subjects with severe renal diseases (men: Scr\\>1.5 / women: Scr\\>1.4);\n3. Subjects with severe liver diseases or whose AST and ALT are at least 2.5 times higher than the upper limits of normal (ULN);\n4. Subjects having the case history of lactic acidosis;\n5. Subjects who have the case history of myocardial infarction or unstable angina or who underwent the coronary artery bypass graft 6 months before the screening test or who have arrhythmia to be treated;\n6. Subjects with congestive heart failures to be treated;\n7. Subjects who fall into New York Heart Association (NYHA) class III or IV;\n8. Subjects having the case history of acute or chronic metabolic acidosis including ketoacidosis;\n9. Subjects who have been pregnant or who are in the period of lactation;\n10. Subjects diagnosed with malignant tumors within 5 years;\n11. Subjects who are hypersensitive to Metformin, Sitagliptin and Acarbose or their ingredients;\n12. Subjects with inflammatory bowel diseases or intestinal ulcers or enterostenosis (includes Subjects who are vulnerable to enterostenosis) or chronic enteric diseases related to digestion and absorption or whose symptoms are likely to worsen due to intestinal gas;\n13. Subjects who participated in other clinical studies as Subjects within 60 days before this study (or before taking the investigational drugs);\n14. Subjects judged unfit for this study by investigators.'}, 'identificationModule': {'nctId': 'NCT01490918', 'briefTitle': 'Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'A Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy of Acarbose Added on Top of Metformin and Sitagliptin Combination Treatment in Type 2 Diabetes Mellitus Patients', 'orgStudyIdInfo': {'id': 'ACADEMIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Acarbose placebo, Metformin, Sitagliptin', 'description': 'The Acarbose placebo should be changed into real Acarbose from the 16th week.', 'interventionNames': ['Drug: Placebo acarbose']}, {'type': 'EXPERIMENTAL', 'label': 'Sitagliptin, Metformin, Acarbose', 'description': 'Metformin, Sitagliptin, Acarbose group', 'interventionNames': ['Drug: Acarbose']}, {'type': 'OTHER', 'label': 'Metformin placebo, Sitagliptin, Acarbose', 'description': 'The Metformin placebo should be changed into real Metformin from the 16th week.', 'interventionNames': ['Drug: placebo metformin']}], 'interventions': [{'name': 'Acarbose', 'type': 'DRUG', 'otherNames': ['triple combination'], 'description': 'Acarbose 50mg b.i.d at first, at the 2nd week 50mg t.i.d and the 4th week, 100mg tid.', 'armGroupLabels': ['Sitagliptin, Metformin, Acarbose']}, {'name': 'Placebo acarbose', 'type': 'DRUG', 'otherNames': ['dual combination (metformin+sitagliptin)'], 'description': 'acarbose placebo', 'armGroupLabels': ['Acarbose placebo, Metformin, Sitagliptin']}, {'name': 'placebo metformin', 'type': 'DRUG', 'otherNames': ['dual combination (acarbose + sitagliptin)'], 'description': 'metformin placebo', 'armGroupLabels': ['Metformin placebo, Sitagliptin, Acarbose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'MedicalExcellence', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kun-HO Yoon, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Medical doctor', 'investigatorFullName': 'Kun-Ho Yoon', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}