Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-02-20 @ 1:43 PM
Study NCT ID:
NCT00103857
Status:
COMPLETED
Last Update Posted:
2017-05-05
First Post:
2005-02-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Colombia', 'Costa Rica', 'Guatemala', 'Hungary', 'Lithuania', 'Malaysia', 'New Zealand', 'Norway', 'Peru', 'Philippines', 'Puerto Rico', 'Russia', 'South Africa', 'United Kingdom', 'United States']}, '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': 'D008687', 'term': 'Metformin'}], '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'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Non-serious adverse experience results represent those events included in the primary safety analysis for this study (i.e., events that occurred prior to the initiation of glycemic rescue therapy).'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin 100 mg q.d.', 'description': 'The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.', 'otherNumAffected': 71, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Metformin 500 mg b.i.d.', 'description': 'The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).', 'otherNumAffected': 74, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Metformin 1000 mg b.i.d.', 'description': 'The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).', 'otherNumAffected': 99, 'seriousNumAffected': 14}, {'id': 'EG003', 'title': 'Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).', 'otherNumAffected': 87, 'seriousNumAffected': 17}, {'id': 'EG004', 'title': 'Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).', 'otherNumAffected': 94, 'seriousNumAffected': 13}, {'id': 'EG005', 'title': 'Placebo/Metformin 1000 mg b.i.d.', 'description': 'The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.', 'otherNumAffected': 73, 'seriousNumAffected': 23}, {'id': 'EG006', 'title': 'Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC', 'description': 'The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.', 'otherNumAffected': 40, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Any Gastrointestinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 42}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 35}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 17}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 25}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Infections And Infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 53}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 54}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 60}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 37}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 24}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Fasting blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 180, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 186, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 171, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Musculoskeletal And Connective Tissue Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 25}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Nervous System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Any Blood And Lymphatic System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Lymphadenopathy Mediastinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Cardiac Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 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unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pyogenic Granuloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Renal Cell Carcinoma Stage Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Retroperitoneal Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Squamous Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Nervous System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cervicobrachial Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Thalamic Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Renal And Urinary Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Micturition Urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Reproductive System And Breast Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Adenomyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Endometrial Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Respiratory, Thoracic And Mediastinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Vascular Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Peripheral Vascular Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Varicose Vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 182, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 176, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}, {'value': '183', 'groupId': 'OG003'}, {'value': '178', 'groupId': 'OG004'}, {'value': '165', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg q.d.', 'description': 'The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.'}, {'id': 'OG001', 'title': 'Metformin 500 mg b.i.d.', 'description': 'The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG002', 'title': 'Metformin 1000 mg b.i.d.', 'description': 'The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG003', 'title': 'Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG004', 'title': 'Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG005', 'title': 'Placebo/Metformin 1000 mg b.i.d.', 'description': 'The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.66', 'groupId': 'OG000', 'lowerLimit': '-0.83', 'upperLimit': '-0.50'}, {'value': '-0.82', 'groupId': 'OG001', 'lowerLimit': '-0.98', 'upperLimit': '-0.66'}, {'value': '-1.13', 'groupId': 'OG002', 'lowerLimit': '-1.29', 'upperLimit': '-0.97'}, {'value': '-1.40', 'groupId': 'OG003', 'lowerLimit': '-1.56', 'upperLimit': '-1.24'}, {'value': '-1.90', 'groupId': 'OG004', 'lowerLimit': '-2.06', 'upperLimit': '-1.74'}, {'value': '0.17', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '0.33'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': 'HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '183', 'groupId': 'OG003'}, {'value': '180', 'groupId': 'OG004'}, {'value': '169', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg q.d.', 'description': 'The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.'}, {'id': 'OG001', 'title': 'Metformin 500 mg b.i.d.', 'description': 'The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG002', 'title': 'Metformin 1000 mg b.i.d.', 'description': 'The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG003', 'title': 'Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG004', 'title': 'Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG005', 'title': 'Placebo/Metformin 1000 mg b.i.d.', 'description': 'The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.5', 'groupId': 'OG000', 'lowerLimit': '-24.1', 'upperLimit': '-10.8'}, {'value': '-27.3', 'groupId': 'OG001', 'lowerLimit': '-34.0', 'upperLimit': '-20.7'}, {'value': '-29.3', 'groupId': 'OG002', 'lowerLimit': '-35.9', 'upperLimit': '-22.6'}, {'value': '-47.1', 'groupId': 'OG003', 'lowerLimit': '-53.7', 'upperLimit': '-40.6'}, {'value': '-63.9', 'groupId': 'OG004', 'lowerLimit': '-70.5', 'upperLimit': '-57.3'}, {'value': '5.8', 'groupId': 'OG005', 'lowerLimit': '-1.0', 'upperLimit': '12.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': 'Change from baseline at Week 24 is defined as Week 24 minus Week 0.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '147', 'groupId': 'OG003'}, {'value': '152', 'groupId': 'OG004'}, {'value': '129', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg q.d.', 'description': 'The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.'}, {'id': 'OG001', 'title': 'Metformin 500 mg b.i.d.', 'description': 'The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG002', 'title': 'Metformin 1000 mg b.i.d.', 'description': 'The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG003', 'title': 'Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG004', 'title': 'Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG005', 'title': 'Placebo/Metformin 1000 mg b.i.d.', 'description': 'The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-51.9', 'groupId': 'OG000', 'lowerLimit': '-62.3', 'upperLimit': '-41.5'}, {'value': '-53.4', 'groupId': 'OG001', 'lowerLimit': '-63.6', 'upperLimit': '-43.2'}, {'value': '-78.0', 'groupId': 'OG002', 'lowerLimit': '-88.3', 'upperLimit': '-67.6'}, {'value': '-92.5', 'groupId': 'OG003', 'lowerLimit': '-102.6', 'upperLimit': '-82.5'}, {'value': '-116.6', 'groupId': 'OG004', 'lowerLimit': '-126.4', 'upperLimit': '-106.7'}, {'value': '0.3', 'groupId': 'OG005', 'lowerLimit': '-10.4', 'upperLimit': '11.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 24', 'description': 'Change from baseline at Week 24 is defined as Week 24 minus Week 0.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '147', 'groupId': 'OG003'}, {'value': '153', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg q.d.', 'description': 'The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.'}, {'id': 'OG001', 'title': 'Metformin 500 mg b.i.d.', 'description': 'The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG002', 'title': 'Metformin 1000 mg b.i.d.', 'description': 'The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG003', 'title': 'Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG004', 'title': 'Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG005', 'title': 'Placebo/Metformin 1000 mg b.i.d.', 'description': 'The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.82', 'groupId': 'OG000', 'lowerLimit': '-1.00', 'upperLimit': '-0.63'}, {'value': '-1.01', 'groupId': 'OG001', 'lowerLimit': '-1.18', 'upperLimit': '-0.83'}, {'value': '-1.34', 'groupId': 'OG002', 'lowerLimit': '-1.50', 'upperLimit': '-1.17'}, {'value': '-1.41', 'groupId': 'OG003', 'lowerLimit': '-1.57', 'upperLimit': '-1.25'}, {'value': '-1.80', 'groupId': 'OG004', 'lowerLimit': '-1.96', 'upperLimit': '-1.65'}, {'value': '-1.10', 'groupId': 'OG005', 'lowerLimit': '-1.32', 'upperLimit': '-0.88'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 54', 'description': 'HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '146', 'groupId': 'OG003'}, {'value': '153', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg q.d.', 'description': 'The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.'}, {'id': 'OG001', 'title': 'Metformin 500 mg b.i.d.', 'description': 'The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG002', 'title': 'Metformin 1000 mg b.i.d.', 'description': 'The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG003', 'title': 'Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG004', 'title': 'Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG005', 'title': 'Placebo/Metformin 1000 mg b.i.d.', 'description': 'The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.0', 'groupId': 'OG000', 'lowerLimit': '-23.2', 'upperLimit': '-8.7'}, {'value': '-29.0', 'groupId': 'OG001', 'lowerLimit': '-35.9', 'upperLimit': '-22.2'}, {'value': '-39.6', 'groupId': 'OG002', 'lowerLimit': '-46.0', 'upperLimit': '-33.2'}, {'value': '-42.5', 'groupId': 'OG003', 'lowerLimit': '-48.6', 'upperLimit': '-36.3'}, {'value': '-55.6', 'groupId': 'OG004', 'lowerLimit': '-61.6', 'upperLimit': '-49.6'}, {'value': '-43.9', 'groupId': 'OG005', 'lowerLimit': '-52.3', 'upperLimit': '-35.5'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 54', 'description': 'Change from baseline at Week 54 is defined as Week 54 minus Week 0.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}, {'value': '132', 'groupId': 'OG004'}, {'value': '66', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg q.d.', 'description': 'The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.'}, {'id': 'OG001', 'title': 'Metformin 500 mg b.i.d.', 'description': 'The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG002', 'title': 'Metformin 1000 mg b.i.d.', 'description': 'The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG003', 'title': 'Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG004', 'title': 'Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG005', 'title': 'Placebo/Metformin 1000 mg b.i.d.', 'description': 'The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-45.9', 'groupId': 'OG000', 'lowerLimit': '-57.2', 'upperLimit': '-34.6'}, {'value': '-58.6', 'groupId': 'OG001', 'lowerLimit': '-69.6', 'upperLimit': '-47.6'}, {'value': '-76.3', 'groupId': 'OG002', 'lowerLimit': '-86.1', 'upperLimit': '-66.5'}, {'value': '-89.6', 'groupId': 'OG003', 'lowerLimit': '-99.2', 'upperLimit': '-80.0'}, {'value': '-107.9', 'groupId': 'OG004', 'lowerLimit': '-117.1', 'upperLimit': '-98.7'}, {'value': '-80.9', 'groupId': 'OG005', 'lowerLimit': '-93.9', 'upperLimit': '-67.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 54', 'description': 'Change from baseline at Week 54 is defined as Week 54 minus Week 0.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg q.d.', 'description': 'The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.'}, {'id': 'OG001', 'title': 'Metformin 500 mg b.i.d.', 'description': 'The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG002', 'title': 'Metformin 1000 mg b.i.d.', 'description': 'The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG003', 'title': 'Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG004', 'title': 'Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG005', 'title': 'Placebo/Metformin 1000 mg b.i.d.', 'description': 'The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.15', 'groupId': 'OG000', 'lowerLimit': '-1.37', 'upperLimit': '-0.92'}, {'value': '-1.06', 'groupId': 'OG001', 'lowerLimit': '-1.26', 'upperLimit': '-0.87'}, {'value': '-1.34', 'groupId': 'OG002', 'lowerLimit': '-1.51', 'upperLimit': '-1.17'}, {'value': '-1.39', 'groupId': 'OG003', 'lowerLimit': '-1.55', 'upperLimit': '-1.22'}, {'value': '-1.66', 'groupId': 'OG004', 'lowerLimit': '-1.81', 'upperLimit': '-1.50'}, {'value': '-1.39', 'groupId': 'OG005', 'lowerLimit': '-1.63', 'upperLimit': '-1.15'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104', 'description': 'HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '96', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg q.d.', 'description': 'The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.'}, {'id': 'OG001', 'title': 'Metformin 500 mg b.i.d.', 'description': 'The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG002', 'title': 'Metformin 1000 mg b.i.d.', 'description': 'The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG003', 'title': 'Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG004', 'title': 'Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG005', 'title': 'Placebo/Metformin 1000 mg b.i.d.', 'description': 'The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.8', 'groupId': 'OG000', 'lowerLimit': '-36.2', 'upperLimit': '-17.4'}, {'value': '-41.4', 'groupId': 'OG001', 'lowerLimit': '-49.8', 'upperLimit': '-33.0'}, {'value': '-43.2', 'groupId': 'OG002', 'lowerLimit': '-50.3', 'upperLimit': '-36.2'}, {'value': '-47.5', 'groupId': 'OG003', 'lowerLimit': '-54.3', 'upperLimit': '-40.7'}, {'value': '-57.3', 'groupId': 'OG004', 'lowerLimit': '-63.7', 'upperLimit': '-50.8'}, {'value': '-45.2', 'groupId': 'OG005', 'lowerLimit': '-55.7', 'upperLimit': '-34.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104', 'description': 'Change from baseline at Week 104 is defined as Week 104 minus Week 0.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '88', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg q.d.', 'description': 'The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.'}, {'id': 'OG001', 'title': 'Metformin 500 mg b.i.d.', 'description': 'The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG002', 'title': 'Metformin 1000 mg b.i.d.', 'description': 'The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG003', 'title': 'Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG004', 'title': 'Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'OG005', 'title': 'Placebo/Metformin 1000 mg b.i.d.', 'description': 'The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-74.1', 'groupId': 'OG000', 'lowerLimit': '-90.3', 'upperLimit': '-57.9'}, {'value': '-72.7', 'groupId': 'OG001', 'lowerLimit': '-87.4', 'upperLimit': '-58.1'}, {'value': '-86.7', 'groupId': 'OG002', 'lowerLimit': '-99.0', 'upperLimit': '-74.5'}, {'value': '-96.2', 'groupId': 'OG003', 'lowerLimit': '-107.8', 'upperLimit': '-84.6'}, {'value': '-110.0', 'groupId': 'OG004', 'lowerLimit': '-120.9', 'upperLimit': '-99.1'}, {'value': '-93.3', 'groupId': 'OG005', 'lowerLimit': '-111.8', 'upperLimit': '-74.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 104', 'description': 'Change from baseline at Week 104 is defined as Week 104 minus Week 0.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin 100 mg q.d.', 'description': 'The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.'}, {'id': 'FG001', 'title': 'Metformin 500 mg b.i.d.', 'description': 'The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'FG002', 'title': 'Metformin 1000 mg b.i.d.', 'description': 'The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'FG003', 'title': 'Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'FG004', 'title': 'Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'FG005', 'title': 'Placebo/Metformin 1000 mg b.i.d.', 'description': 'The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.'}, {'id': 'FG006', 'title': 'Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC', 'description': 'The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.'}], 'periods': [{'title': '54-Week Base Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '179'}, {'groupId': 'FG001', 'numSubjects': '182'}, {'groupId': 'FG002', 'numSubjects': '182'}, {'groupId': 'FG003', 'numSubjects': '190'}, {'groupId': 'FG004', 'numSubjects': '182'}, {'groupId': 'FG005', 'numSubjects': '176'}, {'comment': 'Results for the OLC are through Week 24. Results for the 6 randomized groups are through Week 54.', 'groupId': 'FG006', 'numSubjects': '117'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '126'}, {'groupId': 'FG002', 'numSubjects': '135'}, {'groupId': 'FG003', 'numSubjects': '148'}, {'groupId': 'FG004', 'numSubjects': '141'}, {'groupId': 'FG005', 'numSubjects': '115'}, {'groupId': 'FG006', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '47'}, {'groupId': 'FG003', 'numSubjects': '42'}, {'groupId': 'FG004', 'numSubjects': '41'}, {'groupId': 'FG005', 'numSubjects': '61'}, {'groupId': 'FG006', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '19'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '15'}, {'groupId': 'FG006', 'numSubjects': '4'}]}, {'type': 'protocol discontinuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '5'}]}, {'type': 'patient moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'non-compliance with study procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'patient incarcerated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'laboratory reporting error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'site error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'patient intolerance to rescue therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': '50-Week Extension Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '19 randomized patients completed Period 1 but did not enter Period 2.', 'groupId': 'FG000', 'numSubjects': '103'}, {'comment': '19 randomized patients completed Period 1 but did not enter Period 2.', 'groupId': 'FG001', 'numSubjects': '107'}, {'comment': '14 randomized patients completed Period 1 but did not enter Period 2.', 'groupId': 'FG002', 'numSubjects': '121'}, {'comment': '14 randomized patients completed Period 1 but did not enter Period 2.', 'groupId': 'FG003', 'numSubjects': '134'}, {'comment': '19 randomized patients completed Period 1 but did not enter Period 2.', 'groupId': 'FG004', 'numSubjects': '122'}, {'comment': '17 randomized patients completed Period 1 but did not enter Period 2.', 'groupId': 'FG005', 'numSubjects': '98'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '95'}, {'groupId': 'FG003', 'numSubjects': '98'}, {'groupId': 'FG004', 'numSubjects': '101'}, {'groupId': 'FG005', 'numSubjects': '78'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '36'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '20'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'protocol discontinuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'non-compliance with study procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'patient moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'patient scheduled for elective surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'reason unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First Patient In: 01-Apr-2005\n\nLast Patient Last Visit: 29-Feb-2008\n\n140 study centers worldwide', 'preAssignmentDetails': 'Patients 18-78 years with T2DM and an HbA1c 7.5-11% on diet/exercise were eligible for randomization into the 54-week (wk) base study. Patients with an HbA1c \\>11% or glucose \\>280 mg/dL were eligible to participate in the Open-label Cohort through Wk 24. Randomized patients who completed the base study were eligible to enter a 50-wk extension study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}, {'value': '190', 'groupId': 'BG003'}, {'value': '182', 'groupId': 'BG004'}, {'value': '176', 'groupId': 'BG005'}, {'value': '117', 'groupId': 'BG006'}, {'value': '1208', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin 100 mg q.d.', 'description': 'The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.'}, {'id': 'BG001', 'title': 'Metformin 500 mg b.i.d.', 'description': 'The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'BG002', 'title': 'Metformin 1000 mg b.i.d.', 'description': 'The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'BG003', 'title': 'Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'BG004', 'title': 'Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.', 'description': 'The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study \\[24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B\\] and 50-week extension study).'}, {'id': 'BG005', 'title': 'Placebo/Metformin 1000 mg b.i.d.', 'description': 'The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.'}, {'id': 'BG006', 'title': 'Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC', 'description': 'The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.3', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '53.4', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '53.2', 'spread': '9.6', 'groupId': 'BG002'}, {'value': '54.1', 'spread': '10.0', 'groupId': 'BG003'}, {'value': '53.3', 'spread': '9.6', 'groupId': 'BG004'}, {'value': '53.6', 'spread': '10.0', 'groupId': 'BG005'}, {'value': '52.6', 'spread': '10.0', 'groupId': 'BG006'}, {'value': '53.4', 'spread': '9.9', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}, {'value': '83', 'groupId': 'BG005'}, {'value': '50', 'groupId': 'BG006'}, {'value': '602', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}, {'value': '93', 'groupId': 'BG005'}, {'value': '67', 'groupId': 'BG006'}, {'value': '606', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}, {'value': '81', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}, {'value': '608', 'groupId': 'BG007'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '85', 'groupId': 'BG007'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}, {'value': '54', 'groupId': 'BG006'}, {'value': '351', 'groupId': 'BG007'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '63', 'groupId': 'BG007'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '101', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HbA1c (Hemoglobin A1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '8.9', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '8.7', 'spread': '0.9', 'groupId': 'BG002'}, {'value': '8.8', 'spread': '1.0', 'groupId': 'BG003'}, {'value': '8.7', 'spread': '0.9', 'groupId': 'BG004'}, {'value': '8.7', 'spread': '1.0', 'groupId': 'BG005'}, {'value': '11.2', 'spread': '1.2', 'groupId': 'BG006'}, {'value': '9.0', 'spread': '1.2', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2008-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-31', 'studyFirstSubmitDate': '2005-02-15', 'resultsFirstSubmitDate': '2009-02-19', 'studyFirstSubmitQcDate': '2005-02-15', 'lastUpdatePostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-03-27', 'studyFirstPostDateStruct': {'date': '2005-02-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24', 'timeFrame': 'Week 24', 'description': 'HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24', 'timeFrame': 'Week 24', 'description': 'Change from baseline at Week 24 is defined as Week 24 minus Week 0.'}, {'measure': 'Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24', 'timeFrame': 'Week 24', 'description': 'Change from baseline at Week 24 is defined as Week 24 minus Week 0.'}, {'measure': 'Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54', 'timeFrame': 'Week 54', 'description': 'HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.'}, {'measure': 'Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54', 'timeFrame': 'Week 54', 'description': 'Change from baseline at Week 54 is defined as Week 54 minus Week 0.'}, {'measure': 'Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54', 'timeFrame': 'Week 54', 'description': 'Change from baseline at Week 54 is defined as Week 54 minus Week 0.'}, {'measure': 'Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104', 'timeFrame': 'Week 104', 'description': 'HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.'}, {'measure': 'Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104', 'timeFrame': 'Week 104', 'description': 'Change from baseline at Week 104 is defined as Week 104 minus Week 0.'}, {'measure': 'Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104', 'timeFrame': 'Week 104', 'description': 'Change from baseline at Week 104 is defined as Week 104 minus Week 0.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/policies-perspectives.html', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '17485570', 'type': 'BACKGROUND', 'citation': 'Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Williams-Herman DE; Sitagliptin 036 Study Group. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care. 2007 Aug;30(8):1979-87. doi: 10.2337/dc07-0627. Epub 2007 May 7.'}, {'pmid': '32501595', 'type': 'DERIVED', 'citation': 'Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n54-Week Base Study:\n\n* Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes)\n\n 50-Week Extension Study:\n* Patients who complete the 54-week base study are eligible to enter the 50-week extension study\n\nExclusion Criteria:\n\n* Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes)'}, 'identificationModule': {'nctId': 'NCT00103857', 'briefTitle': 'MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind Factorial Study of the Co-Administration of MK0431 and Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control', 'orgStudyIdInfo': {'id': '0431-036'}, 'secondaryIdInfos': [{'id': 'MK0431-036'}, {'id': '2005_003'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'MK0431 100 mg q.d.', 'interventionNames': ['Drug: Comparator: MK0431 100 mg q.d. (q.d. = once daily)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Metformin 500 mg b.i.d.', 'interventionNames': ['Drug: Comparator: Metformin 500 mg b.i.d.']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Metformin 1000 mg b.i.d.', 'interventionNames': ['Drug: Comparator: Metformin 1000 mg b.i.d.']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Coadministration of MK0431 and Metformin 50/500 mg b.i.d.', 'interventionNames': ['Drug: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)', 'Drug: Comparator: Metformin 500 mg b.i.d.']}, {'type': 'EXPERIMENTAL', 'label': '5', 'description': 'Coadministration of MK0431 and Metformin 50/1000 mg b.i.d.', 'interventionNames': ['Drug: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)', 'Drug: Comparator: Metformin 1000 mg b.i.d.']}, {'type': 'PLACEBO_COMPARATOR', 'label': '6', 'description': 'Placebo/Metformin 1000 mg b.i.d.', 'interventionNames': ['Drug: Comparator: Placebo (Phase A)/Metformin (Phase B)']}, {'type': 'EXPERIMENTAL', 'label': '7', 'description': 'Non-Randomized, Open-Label: Coadministration MK0431 and Metformin 50/1000 mg b.i.d.', 'interventionNames': ['Drug: Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.']}], 'interventions': [{'name': 'Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)', 'type': 'DRUG', 'otherNames': ['MK0431'], 'description': 'MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take MK0431 50 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.', 'armGroupLabels': ['4', '5']}, {'name': 'Comparator: MK0431 100 mg q.d. (q.d. = once daily)', 'type': 'DRUG', 'description': 'MK0431 oral tablets will be started on Day 1 as two 50 mg tablets (100 mg q.d.) (q.d. = once daily) and continued at this dose throughout the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.', 'armGroupLabels': ['1']}, {'name': 'Comparator: Placebo (Phase A)/Metformin (Phase B)', 'type': 'DRUG', 'description': 'During the placebo-controlled period (Day 1 through Week 24/Phase A), metformin and MK0431 matching placebos will be dispensed as oral tablets. At the beginning of the 30-week active-controlled period (Phase B), metformin will be started as 500 mg q.d. (q.d. = once daily) and up-titrated in 500 mg weekly increments to a stable dose of 1000 mg b.i.d. Patients who complete the 54-week base study and who enter the 50-week extension study will continue to take metformin 1000 mg b.i.d. (b.i.d. = twice daily) for a total placebo/metformin treatment duration of up to 104 weeks.', 'armGroupLabels': ['6']}, {'name': 'Comparator: Metformin 500 mg b.i.d.', 'type': 'DRUG', 'description': 'Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased after 1 week to a stable dose of 500 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 500 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.', 'armGroupLabels': ['2', '4']}, {'name': 'Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.', 'type': 'DRUG', 'description': 'MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Metformin oral tablets will be started on Day 1 at 500 mg q.d. and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. The open-label treatment period is 24 weeks.', 'armGroupLabels': ['7']}, {'name': 'Comparator: Metformin 1000 mg b.i.d.', 'type': 'DRUG', 'description': 'Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 1000 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.', 'armGroupLabels': ['3', '5']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}