Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-29 @ 10:02 PM
Study NCT ID:
NCT01183104
Status:
COMPLETED
Last Update Posted:
2017-04-14
First Post:
2010-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
START-J: SiTAgliptin in eldeRly Trial in Japan
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': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'C057619', 'term': 'glimepiride'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'terauchi-tky@umin.ac.jp', 'phone': '+81-3-3514-1721', 'title': 'Prof. Yasuo Terauchi', 'organization': 'Japan Association for Diabetes Education and Care'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin', 'description': 'Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\\< \\<50).', 'otherNumAtRisk': 148, 'otherNumAffected': 33, 'seriousNumAtRisk': 148, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Glimepiride', 'description': 'Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg', 'otherNumAtRisk': 143, 'otherNumAffected': 31, 'seriousNumAtRisk': 143, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Intestinal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 7}], 'organSystem': 'Infections and infestations'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Helicobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Bile ｄuct ｃancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Colon ｃancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Polycythemia vera', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Thyroid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Mediastinal lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hypoesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Allergic conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Pterygium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Retinal hemorrhages', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Erosive gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hemorrhoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Choledocholith', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Liver Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Seborrheic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hives', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Spondylosis deformans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Hygroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Tenovaginitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Ureteral calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Face edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'T-wave abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Sprained ligament', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Wrist join fraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Ureteral stone removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Dental care', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Infectious enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Acute myeloid leukemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Tongue neoplasm malignant stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Hemorrhagic diathesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hyphema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Complete atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Takotsubo cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Colon polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dermatitis exfoliative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Trismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Globe rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c at 52 W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\\< \\<50).'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.66', 'groupId': 'OG000', 'lowerLimit': '-0.77', 'upperLimit': '-0.54'}, {'value': '-0.77', 'groupId': 'OG001', 'lowerLimit': '-0.88', 'upperLimit': '-0.66'}]}]}], 'analyses': [{'pValue': '0.087', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The pre-defined non-inferiority margin was 0.3%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 52 W', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set of evaluation for efficacy; Per Protocol Set.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Hypoglycaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\\< \\<50).'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to 52 W', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set of evaluation for safety.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants Achieving HbA1c < 6.9 %', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\\< \\<50).'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 W', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set of evaluation for efficacy; Per Protocol Set Some participants were not completed to 52 W.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HOMA-β at 52 W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\\< \\<50).'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '35.7', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '56.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.030', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 52 W', 'description': 'β cell function is measured by the Homeostatic Model Assessment(HOMA-β). HOMA β = \\[20 x fasting insulin (μU/mL)\\] / \\[fasting plasma glucose (mmol/L) - 3.5\\]', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin/Proinsulin Ratio at 52 W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\\< \\<50).'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.049', 'spread': '0.111', 'groupId': 'OG000'}, {'value': '-0.002', 'spread': '0.095', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 52 W', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at 52 W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\\< \\<50).'}, {'id': 'OG001', 'title': 'Glimepiride', 'description': 'Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.367', 'spread': '2.441', 'groupId': 'OG000'}, {'value': '0.309', 'spread': '2.915', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 52 W', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set of evaluation for efficacy; Per Protocol Set. Some participants had loss of the measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin', 'description': 'Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=\\< \\<50).'}, {'id': 'FG001', 'title': 'Glimepiride', 'description': 'Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'Received Study Drug', 'comment': 'Analysis set of evaluation for safety', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'Continued Treatment for 12 Weeks', 'comment': 'Analysis set of evaluation for efficacy; Per Protocol Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '129'}]}, {'type': 'Completed 52-week Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'Enrolled in Extension Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'comment': '104-week extension study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '92'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Nonparticipation in Extension Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'Did not receive study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin', 'description': 'Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=\\< \\<50).'}, {'id': 'BG001', 'title': 'Glimepiride', 'description': 'Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.2', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '70.8', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '70.5', 'spread': '5.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '7.48', 'spread': '0.68', 'groupId': 'BG000'}, {'value': '7.49', 'spread': '0.67', 'groupId': 'BG001'}, {'value': '7.48', 'spread': '0.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '24.1', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '24.2', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '24.2', 'spread': '3.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'eGFR', 'classes': [{'categories': [{'measurements': [{'value': '68.8', 'spread': '17.1', 'groupId': 'BG000'}, {'value': '67.9', 'spread': '17.1', 'groupId': 'BG001'}, {'value': '68.4', 'spread': '17.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body weight', 'classes': [{'categories': [{'measurements': [{'value': '60.9', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '60.9', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '60.9', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HOMA-β', 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'spread': '33.7', 'groupId': 'BG000'}, {'value': '38.5', 'spread': '34.0', 'groupId': 'BG001'}, {'value': '41.1', 'spread': '33.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insulin/Proinsulin Ratio', 'classes': [{'categories': [{'measurements': [{'value': '0.217', 'spread': '0.122', 'groupId': 'BG000'}, {'value': '0.205', 'spread': '0.129', 'groupId': 'BG001'}, {'value': '0.211', 'spread': '0.125', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Analysis set of evaluation for efficacy ; Per Protocol Set'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 305}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-03', 'studyFirstSubmitDate': '2010-08-16', 'resultsFirstSubmitDate': '2016-12-05', 'studyFirstSubmitQcDate': '2010-08-16', 'lastUpdatePostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-03', 'studyFirstPostDateStruct': {'date': '2010-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c at 52 W', 'timeFrame': 'Baseline and 52 W'}, {'measure': 'Number of Participants With Hypoglycaemia', 'timeFrame': 'From baseline to 52 W'}], 'secondaryOutcomes': [{'measure': 'The Number of Participants Achieving HbA1c < 6.9 %', 'timeFrame': '52 W'}, {'measure': 'Change From Baseline in HOMA-β at 52 W', 'timeFrame': 'Baseline and 52 W', 'description': 'β cell function is measured by the Homeostatic Model Assessment(HOMA-β). HOMA β = \\[20 x fasting insulin (μU/mL)\\] / \\[fasting plasma glucose (mmol/L) - 3.5\\]'}, {'measure': 'Change From Baseline in Insulin/Proinsulin Ratio at 52 W', 'timeFrame': 'Baseline and 52 W'}, {'measure': 'Change From Baseline in Body Weight at 52 W', 'timeFrame': 'Baseline and 52 W'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 2 Diabetes', 'Sitagliptin', 'Glimepiride', 'Elderly patients', 'Japanese'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '28294488', 'type': 'DERIVED', 'citation': 'Terauchi Y, Yamada Y, Ishida H, Ohsugi M, Kitaoka M, Satoh J, Yabe D, Shihara N, Seino Y. Efficacy and safety of sitagliptin as compared with glimepiride in Japanese patients with type 2 diabetes mellitus aged >/= 60 years (START-J trial). Diabetes Obes Metab. 2017 Aug;19(8):1188-1192. doi: 10.1111/dom.12933. Epub 2017 Apr 12.'}], 'seeAlsoLinks': [{'url': 'https://www.nittokyo.or.jp/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and the safety of sitagliptin and glimepiride in drug naïve elderly patients with Type 2 diabetes as evaluated by HbA1c change from baseline at 52 W as efficacy and incidence of hypoglycemia from randomization to 52 W as safety. The clinical hypotheses are non-inferiority of sitagliptin to glimepiride in efficacy as judged by HbA1c change from baseline at 52 W and superiority of sitagliptin to glimepiride in safety as judged by incidence of hypoglycemia in drug naïve elderly patients with T2DM. In addition, comparison of efficacy is extended to 104 W.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with type 2 diabetes who are oral hypoglycemic agent naive or, α-glucosidase inhibitor or biguanide monotherapy (to be washed out 4 weeks prior to randomization)\n2. Signed informed consent obtained before any trial-related activities\n3. Treatment with diet and exercise for 12 weeks and longer at screening\n4. Age =\\>60 y.o.\n5. Male and Female\n6. HbA1c 6.9%=\\< \\<8.9%\n\nExclusion Criteria:\n\n1. Active proliferative retinopathy or maculopathy requiring treatment\n2. Liver dysfunction (\\>x2 of upper normal limit), moderate or severe renal dysfunction(serum Cr\\>1.5mg/dL in male, Cr\\>1.3mg/dL in female, eGFR\\<30), severe cardiac disease (NYHA III or IV), malignancy or uncontrolled hypertension (treated or untreated) as judged by the Investigator\n3. Mental incapacity (including moderate or severe dementia) precluding adequate understanding and/or cooperation as judged by the Investigator\n4. Recurrent hypoglycaemia or hypoglycaemic unawareness as judged by the investigator\n5. Previous history of severe allergy to pharmaceutical products\n6. Systemic glucocorticoids users or potential users\n7. Suspected type 1 diabetes (including slowly progressive insulin dependent diabetes mellitus) or positive anti-glutamic acid decarboxylase antibody\n8. Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis'}, 'identificationModule': {'nctId': 'NCT01183104', 'acronym': 'START-J', 'briefTitle': 'START-J: SiTAgliptin in eldeRly Trial in Japan', 'organization': {'class': 'OTHER', 'fullName': 'Japan Association for Diabetes Education and Care'}, 'officialTitle': 'Efficacy and Safety Comparison of Sitagliptin and Glimepiride in Elderly Japanese Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'START-J'}, 'secondaryIdInfos': [{'id': 'UMIN000004047', 'type': 'OTHER', 'domain': 'UMIN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sitagliptin', 'interventionNames': ['Drug: Sitagliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glimepiride', 'interventionNames': ['Drug: Glimepiride']}], 'interventions': [{'name': 'Sitagliptin', 'type': 'DRUG', 'description': 'Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=\\< \\<50).', 'armGroupLabels': ['Sitagliptin']}, {'name': 'Glimepiride', 'type': 'DRUG', 'description': 'Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg', 'armGroupLabels': ['Glimepiride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '102-0083', 'city': 'Chiyoda-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Japan Association for Diabetes Education and Care'}], 'overallOfficials': [{'name': 'Yasuo Terauchi, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yokohama City University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Japan Association for Diabetes Education and Care', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}