Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-01-07 @ 8:30 AM
Study NCT ID:
NCT01301833
Status:
COMPLETED
Last Update Posted:
2015-11-18
First Post:
2011-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C579035', 'term': '3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D065089', 'term': 'Glycoside Hydrolase Inhibitors'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cti-inq-ml@ml.mt-pharma.co.jp', 'title': 'Clinical Trials, Information Desk', 'organization': 'Mitsubishi Tanabe Pharma Corporation'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Teneligliptin', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )', 'otherNumAtRisk': 212, 'otherNumAffected': 182, 'seriousNumAtRisk': 212, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Teneligliptin and Glinide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide', 'otherNumAtRisk': 80, 'otherNumAffected': 72, 'seriousNumAtRisk': 80, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Teneligliptin and Biguanide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide', 'otherNumAtRisk': 95, 'otherNumAffected': 81, 'seriousNumAtRisk': 95, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Teneligliptin and Alpha-glucosidase Inhibitor', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor', 'otherNumAtRisk': 75, 'otherNumAffected': 59, 'seriousNumAtRisk': 75, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Body tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Cellulitis orbital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Dermatitis infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Mumps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Pneumonia mycoplasmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Pulpitis dental', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Urethritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 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infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Gingival abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Helicobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Mycoplasma infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Dental gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Haemangioma of liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Seborrhoeic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Thyroid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 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'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 95, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 75, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA(15.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Teneligliptin', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )'}, {'id': 'OG001', 'title': 'Teneligliptin and Glinide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide'}, {'id': 'OG002', 'title': 'Teneligliptin and Biguanide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide'}, {'id': 'OG003', 'title': 'Teneligliptin and Alpha-glucosidase Inhibitor', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor'}], 'classes': [{'title': 'Serious Adverse Event', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Other Adverse Event', 'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 Weeks', 'description': 'Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set, consisting of all patients, who received at least one dose of study drug and who had at least one safety data after the treatment of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Teneligliptin', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )'}, {'id': 'OG001', 'title': 'Teneligliptin and Glinide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide'}, {'id': 'OG002', 'title': 'Teneligliptin and Biguanide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide'}, {'id': 'OG003', 'title': 'Teneligliptin and Alpha-glucosidase Inhibitor', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '0.70', 'groupId': 'OG001'}, {'value': '-0.78', 'spread': '0.75', 'groupId': 'OG002'}, {'value': '-0.89', 'spread': '0.64', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 52 weeks', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Teneligliptin', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )'}, {'id': 'OG001', 'title': 'Teneligliptin and Glinide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide'}, {'id': 'OG002', 'title': 'Teneligliptin and Biguanide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide'}, {'id': 'OG003', 'title': 'Teneligliptin and Alpha-glucosidase Inhibitor', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.7', 'spread': '25.5', 'groupId': 'OG000'}, {'value': '-13.7', 'spread': '23.7', 'groupId': 'OG001'}, {'value': '-12.7', 'spread': '27.1', 'groupId': 'OG002'}, {'value': '-19.5', 'spread': '23.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 52 weeks', 'unitOfMeasure': 'mg / dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Glucagon at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Teneligliptin', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )'}, {'id': 'OG001', 'title': 'Teneligliptin and Glinide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide'}, {'id': 'OG002', 'title': 'Teneligliptin and Biguanide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide'}, {'id': 'OG003', 'title': 'Teneligliptin and Alpha-glucosidase Inhibitor', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '13.7', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '14.4', 'groupId': 'OG002'}, {'value': '6.9', 'spread': '15.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 52 weeks', 'unitOfMeasure': 'pg / mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Teneligliptin', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )'}, {'id': 'OG001', 'title': 'Teneligliptin and Glinide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide'}, {'id': 'OG002', 'title': 'Teneligliptin and Biguanide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide'}, {'id': 'OG003', 'title': 'Teneligliptin and Alpha-glucosidase Inhibitor', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor'}], 'classes': [{'categories': [{'measurements': [{'value': '0.988', 'spread': '8.314', 'groupId': 'OG000'}, {'value': '0.211', 'spread': '2.378', 'groupId': 'OG001'}, {'value': '-0.173', 'spread': '9.093', 'groupId': 'OG002'}, {'value': '-0.330', 'spread': '2.713', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 52 weeks', 'unitOfMeasure': 'μU / mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Teneligliptin', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )'}, {'id': 'FG001', 'title': 'Teneligliptin and Glinide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide'}, {'id': 'FG002', 'title': 'Teneligliptin and Biguanide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide'}, {'id': 'FG003', 'title': 'Teneligliptin and Alpha-glucosidase Inhibitor', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '95'}, {'groupId': 'FG003', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '88'}, {'groupId': 'FG003', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Personal matter', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}, {'value': '462', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Teneligliptin', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )'}, {'id': 'BG001', 'title': 'Teneligliptin and Glinide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide'}, {'id': 'BG002', 'title': 'Teneligliptin and Biguanide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide'}, {'id': 'BG003', 'title': 'Teneligliptin and Alpha-glucosidase Inhibitor', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '291', 'groupId': 'BG004'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '171', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '164', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '298', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 462}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-15', 'studyFirstSubmitDate': '2011-02-14', 'resultsFirstSubmitDate': '2015-07-31', 'studyFirstSubmitQcDate': '2011-02-21', 'lastUpdatePostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-31', 'studyFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': '52 Weeks', 'description': 'Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c at Week 52', 'timeFrame': 'Baseline and 52 weeks'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose at Week 52', 'timeFrame': 'Baseline and 52 weeks'}, {'measure': 'Change From Baseline in Fasting Glucagon at Week 52', 'timeFrame': 'Baseline and 52 weeks'}, {'measure': 'Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52', 'timeFrame': 'Baseline and 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insulin resistance'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25861982', 'type': 'RESULT', 'citation': 'Kadowaki T, Marubayashi F, Yokota S, Katoh M, Iijima H. Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies. Expert Opin Pharmacother. 2015 May;16(7):971-81. doi: 10.1517/14656566.2015.1032249. Epub 2015 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug\n* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug\n* Patients whose HbA1c is between 6.5% - 10.0%\n* Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)\n* Patients who are accepting treatments of arrhythmias\n* Patients with serious diabetic complications\n* Patients who are habitual excessive alcohol consumption.\n* Patients with severe hepatic disorder or severe renal disorder.\n* Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception'}, 'identificationModule': {'nctId': 'NCT01301833', 'briefTitle': 'Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'Long-term Safety Study of MP-513 as Monotherapy or in Combination With Oral Antihyperglycaemic Agent in Japanese Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '3000-A14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'teneligliptin', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )', 'interventionNames': ['Drug: teneligliptin']}, {'type': 'EXPERIMENTAL', 'label': 'teneligliptin and glinide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide', 'interventionNames': ['Drug: teneligliptin', 'Drug: glinide']}, {'type': 'EXPERIMENTAL', 'label': 'teneligliptin and biguanide', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide', 'interventionNames': ['Drug: teneligliptin', 'Drug: biguanide']}, {'type': 'EXPERIMENTAL', 'label': 'teneligliptin and alpha-glucosidase inhibitor', 'description': 'teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor', 'interventionNames': ['Drug: teneligliptin', 'Drug: alpha-glucosidase inhibitor']}], 'interventions': [{'name': 'teneligliptin', 'type': 'DRUG', 'otherNames': ['MP-513'], 'armGroupLabels': ['teneligliptin', 'teneligliptin and alpha-glucosidase inhibitor', 'teneligliptin and biguanide', 'teneligliptin and glinide']}, {'name': 'glinide', 'type': 'DRUG', 'armGroupLabels': ['teneligliptin and glinide']}, {'name': 'biguanide', 'type': 'DRUG', 'armGroupLabels': ['teneligliptin and biguanide']}, {'name': 'alpha-glucosidase inhibitor', 'type': 'DRUG', 'armGroupLabels': ['teneligliptin and alpha-glucosidase inhibitor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chitose-shi', 'state': 'Hokkaido', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Takashi Kadowaki, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tokyo University'}, {'name': 'Kazuoki Kondo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanabe Pharma Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}