Viewing Study NCT01708902

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Ignite Creation Date: 2025-12-25 @ 4:04 AM
Ignite Modification Date: 2025-12-26 @ 3:00 AM
Study NCT ID: NCT01708902
Status: COMPLETED
Last Update Posted: 2015-04-24
First Post: 2012-10-16
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069476', 'term': 'Linagliptin'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration (week 1) until end of treatment, up to 24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Main: Linagliptin 5mg QD', 'description': 'Main Group: Patients once daily received linagliptin 5mg QD, administered oral as tablet.', 'otherNumAtRisk': 147, 'otherNumAffected': 30, 'seriousNumAtRisk': 147, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Main: Metformin 500mg BID', 'description': 'Main Group: Patients twice daily received metformin 500mg BID, administered oral as tablet.', 'otherNumAtRisk': 145, 'otherNumAffected': 31, 'seriousNumAtRisk': 145, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Main: Metformin 1000mg BID', 'description': 'Main Group: Patients twice daily received metformin 1000mg BID, administered oral as tablet.', 'otherNumAtRisk': 144, 'otherNumAffected': 42, 'seriousNumAtRisk': 144, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Main: Linagliptin 2.5mg / Metformin 500mg BID', 'description': 'Main Group: Patients twice daily received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.', 'otherNumAtRisk': 147, 'otherNumAffected': 32, 'seriousNumAtRisk': 147, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Main: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Main Group: Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.', 'otherNumAtRisk': 147, 'otherNumAffected': 41, 'seriousNumAtRisk': 147, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'APG: Linagliptin 5mg QD up to Week 12', 'description': 'Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet.\n\n(Data up to week 12)', 'otherNumAtRisk': 71, 'otherNumAffected': 20, 'seriousNumAtRisk': 71, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'APG: Linagliptin 2.5mg / Metformin 1000mg BID up to Week 12', 'description': 'Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.\n\n(Data up to week 12)', 'otherNumAtRisk': 72, 'otherNumAffected': 15, 'seriousNumAtRisk': 72, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'APG: Linagliptin 5mg After Week 12', 'description': 'Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet. Data from week 12 to week 24', 'otherNumAtRisk': 33, 'otherNumAffected': 2, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'APG: Linagliptin 5mg - Linagliptin 2.5mg / Met After Week 12', 'description': 'Additional parallel group (APG): Patients who received linagliptin 5mg QD, administered oral as tablet during the first 12 weeks and switched to linagliptin 2.5mg and metformin 1000mg (met) BID, administered oral as fixed dose combination (FDC) tablet from week 12 to week 24. Data from week 12 to week 24.', 'otherNumAtRisk': 31, 'otherNumAffected': 9, 'seriousNumAtRisk': 31, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': 'APG: Linagliptin 2.5mg / Metformin 1000mg After Week 12', 'description': 'Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.\n\nData from week 12 to week 24.', 'otherNumAtRisk': 65, 'otherNumAffected': 9, 'seriousNumAtRisk': 65, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Otosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Pituitary tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}, {'term': 'Breast disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Main: Linagliptin 5mg QD', 'description': 'Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.'}, {'id': 'OG001', 'title': 'Main: Metformin 500mg BID', 'description': 'Main Group: Patients received metformin 500mg BID, administered oral as tablet.'}, {'id': 'OG002', 'title': 'Main: Metformin 1000mg BID', 'description': 'Main Group: Patients received metformin 1000mg BID, administered oral as tablet.'}, {'id': 'OG003', 'title': 'Main: Linagliptin 2.5mg / Metformin 500mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.'}, {'id': 'OG004', 'title': 'Main: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.29', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-1.64', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '-2.07', 'spread': '0.08', 'groupId': 'OG002'}, {'value': '-2.15', 'spread': '0.08', 'groupId': 'OG003'}, {'value': '-2.29', 'spread': '0.08', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0587', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': "The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.", 'groupDescription': "The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.\n\nThe null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c.", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.00', 'ciLowerLimit': '-1.23', 'ciUpperLimit': '-0.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'estimateComment': "The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.", 'groupDescription': "The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.\n\nThe null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c.", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '-0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'estimateComment': "The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Metformin 500mg BID'.", 'groupDescription': "The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.\n\nThe null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c.", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-1.09', 'ciUpperLimit': '-0.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'estimateComment': "The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.", 'groupDescription': "The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.\n\nThe null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c.", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 24', 'description': 'The change from baseline in HbA1c after 24 weeks of treatment in main group.\n\nThe mean was adjusted by baseline HbA1c and treatment group.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): all randomised and treated patients who had a baseline and at least 1 on-treatment HbA1c value As the imputation rule for missing data the last observation carried forward (LOCF) was used.'}, {'type': 'SECONDARY', 'title': 'The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 24 Weeks of Treatment in Main Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Main: Linagliptin 5mg QD', 'description': 'Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.'}, {'id': 'OG001', 'title': 'Main: Metformin 500mg BID', 'description': 'Main Group: Patients received metformin 500mg BID, administered oral as tablet.'}, {'id': 'OG002', 'title': 'Main: Metformin 1000mg BID', 'description': 'Main Group: Patients received metformin 1000mg BID, administered oral as tablet.'}, {'id': 'OG003', 'title': 'Main: Linagliptin 2.5mg / Metformin 500mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.'}, {'id': 'OG004', 'title': 'Main: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.6', 'groupId': 'OG000', 'lowerLimit': '35.2', 'upperLimit': '52.2'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '41.6', 'upperLimit': '58.4'}, {'value': '69.0', 'groupId': 'OG002', 'lowerLimit': '60.3', 'upperLimit': '76.8'}, {'value': '72.1', 'groupId': 'OG003', 'lowerLimit': '63.9', 'upperLimit': '79.4'}, {'value': '77.1', 'groupId': 'OG004', 'lowerLimit': '69.3', 'upperLimit': '83.8'}]}]}], 'analyses': [{'pValue': '0.0771', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.673', 'ciLowerLimit': '0.946', 'ciUpperLimit': '2.961', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.487', 'groupDescription': "Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.489', 'ciLowerLimit': '3.164', 'ciUpperLimit': '9.522', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.543', 'groupDescription': "Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.829', 'ciLowerLimit': '1.678', 'ciUpperLimit': '4.767', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.753', 'groupDescription': "Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.818', 'ciLowerLimit': '2.259', 'ciUpperLimit': '6.454', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.023', 'groupDescription': "Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 (after first drug administration)', 'description': 'The occurrence of treat to target efficacy response in terms of HbA1c \\< 7.0 % after 24 weeks of treatment in main group.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - non-completers were considered as nonresponders (NCF)'}, {'type': 'SECONDARY', 'title': 'The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 12 Weeks of Treatment in APG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APG: Linagliptin 5mg QD', 'description': 'Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.\n\n(Data up to week 12)'}, {'id': 'OG001', 'title': 'APG: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.\n\n(Data up to week 12)'}], 'classes': [{'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '39.1'}, {'value': '58.8', 'groupId': 'OG001', 'lowerLimit': '46.2', 'upperLimit': '70.6'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.169', 'ciLowerLimit': '1.997', 'ciUpperLimit': '8.701', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.565', 'groupDescription': "Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 (after first drug administration)', 'description': 'The occurrence of treat to target efficacy response in terms of HbA1c \\< 7.0 % after 12 weeks of treatment in APG.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (NCF)'}, {'type': 'SECONDARY', 'title': 'The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 24 Weeks of Treatment in Main Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Main: Linagliptin 5mg QD', 'description': 'Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.'}, {'id': 'OG001', 'title': 'Main: Metformin 500mg BID', 'description': 'Main Group: Patients received metformin 500mg BID, administered oral as tablet.'}, {'id': 'OG002', 'title': 'Main: Metformin 1000mg BID', 'description': 'Main Group: Patients received metformin 1000mg BID, administered oral as tablet.'}, {'id': 'OG003', 'title': 'Main: Linagliptin 2.5mg / Metformin 500mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.'}, {'id': 'OG004', 'title': 'Main: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '31.3'}, {'value': '34.7', 'groupId': 'OG001', 'lowerLimit': '27.0', 'upperLimit': '43.1'}, {'value': '50.4', 'groupId': 'OG002', 'lowerLimit': '41.6', 'upperLimit': '59.2'}, {'value': '56.3', 'groupId': 'OG003', 'lowerLimit': '47.8', 'upperLimit': '64.6'}, {'value': '60.3', 'groupId': 'OG004', 'lowerLimit': '51.7', 'upperLimit': '68.4'}]}]}], 'analyses': [{'pValue': '0.0480', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.661', 'ciLowerLimit': '1.004', 'ciUpperLimit': '2.746', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.426', 'groupDescription': "Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.923', 'ciLowerLimit': '3.452', 'ciUpperLimit': '10.164', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.632', 'groupDescription': "Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.574', 'ciLowerLimit': '1.563', 'ciUpperLimit': '4.239', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.655', 'groupDescription': "Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.682', 'ciLowerLimit': '2.751', 'ciUpperLimit': '7.968', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.270', 'groupDescription': "Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 (after first drug administration)', 'description': 'The occurrence of treat to target efficacy response in terms of HbA1c \\< 6.5% after 24 weeks of treatment in main group.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (NCF)'}, {'type': 'SECONDARY', 'title': 'The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 12 Weeks of Treatment in APG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APG: Linagliptin 5mg QD', 'description': 'Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.\n\n(Data up to week 12)'}, {'id': 'OG001', 'title': 'APG: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.\n\n(Data up to week 12)'}], 'classes': [{'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '26.4'}, {'value': '36.8', 'groupId': 'OG001', 'lowerLimit': '25.4', 'upperLimit': '49.3'}]}]}], 'analyses': [{'pValue': '0.0062', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.135', 'ciLowerLimit': '1.383', 'ciUpperLimit': '7.110', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.310', 'groupDescription': "Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 (after first drug administration)', 'description': 'The occurrence of treat to target efficacy response in terms of HbA1c \\< 6.5% after 12 weeks of treatment in APG.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (NCF)'}, {'type': 'PRIMARY', 'title': 'The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}, {'value': '128', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Main: Linagliptin 5mg QD', 'description': 'Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.'}, {'id': 'OG001', 'title': 'Main: Metformin 500mg BID', 'description': 'Main Group: Patients received metformin 500mg BID, administered oral as tablet.'}, {'id': 'OG002', 'title': 'Main: Metformin 1000mg BID', 'description': 'Main Group: Patients received metformin 1000mg BID, administered oral as tablet.'}, {'id': 'OG003', 'title': 'Main: Linagliptin 2.5mg / Metformin 500mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.'}, {'id': 'OG004', 'title': 'Main: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.34', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-1.68', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '-2.08', 'spread': '0.08', 'groupId': 'OG002'}, {'value': '-2.16', 'spread': '0.08', 'groupId': 'OG003'}, {'value': '-2.38', 'spread': '0.08', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0109', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '-0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': "The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.", 'groupDescription': 'Sensitivity analysis: Mixed Model for repeated measurements\n\nThe model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.04', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '-0.81', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': "The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.", 'groupDescription': 'Sensitivity analysis: Mixed Model for repeated measurements\n\nThe model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '-0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': "The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID ' minus 'Main: Metformin 500mg BID' .", 'groupDescription': 'Sensitivity analysis: Mixed Model for repeated measurements\n\nThe model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.81', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '-0.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': "The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.", 'groupDescription': 'Sensitivity analysis: Mixed Model for repeated measurements\n\nThe model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 24', 'description': 'The change from baseline in HbA1c after 24 weeks of treatment in main group. Only subjects from the FAS with measured HbA1c values (observed cases \\[OC\\]) were considered.\n\nThe mean was adjusted by treatment, baseline HbA1c, week and treatment\\*week.\n\nThe sensitivity analysis was added as the primary analysis failed with borderline results.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (OC): subjects from the FAS with measured HbA1c values (observed cases \\[OC\\]) were considered'}, {'type': 'PRIMARY', 'title': 'The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APG: Linagliptin 5mg QD', 'description': 'Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.\n\n(Data up to week 12)'}, {'id': 'OG001', 'title': 'APG: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.\n\n(Data up to week 12)'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.46', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-4.71', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.25', 'ciLowerLimit': '-1.87', 'ciUpperLimit': '-0.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'estimateComment': "The adjusted mean difference was calculated as the adjusted mean of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'APG: Linagliptin 5mg QD'.", 'groupDescription': "The treatment effect of the 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' was compared with 'APG: Linagliptin 5mg QD'.\n\nThe model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12', 'description': 'The change from baseline in HbA1c after 12 weeks of treatment in additional parallel group (APG)\n\nThe mean was adjusted by baseline HbA1c and treatment group.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (LOCF)'}, {'type': 'SECONDARY', 'title': 'The Occurrence of Relative Efficacy Response in Main Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Main: Linagliptin 5mg QD', 'description': 'Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.'}, {'id': 'OG001', 'title': 'Main: Metformin 500mg BID', 'description': 'Main Group: Patients received metformin 500mg BID, administered oral as tablet.'}, {'id': 'OG002', 'title': 'Main: Metformin 1000mg BID', 'description': 'Main Group: Patients received metformin 1000mg BID, administered oral as tablet.'}, {'id': 'OG003', 'title': 'Main: Linagliptin 2.5mg / Metformin 500mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.'}, {'id': 'OG004', 'title': 'Main: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.0', 'groupId': 'OG000', 'lowerLimit': '64.9', 'upperLimit': '80.2'}, {'value': '80.6', 'groupId': 'OG001', 'lowerLimit': '73.1', 'upperLimit': '86.7'}, {'value': '89.5', 'groupId': 'OG002', 'lowerLimit': '83.0', 'upperLimit': '94.1'}, {'value': '93.0', 'groupId': 'OG003', 'lowerLimit': '87.4', 'upperLimit': '96.6'}, {'value': '89.4', 'groupId': 'OG004', 'lowerLimit': '83.1', 'upperLimit': '93.9'}]}]}], 'analyses': [{'pValue': '0.9705', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.986', 'ciLowerLimit': '0.456', 'ciUpperLimit': '2.130', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.387', 'groupDescription': "Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0007', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.093', 'ciLowerLimit': '1.612', 'ciUpperLimit': '5.938', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.029', 'groupDescription': "Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0029', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.190', 'ciLowerLimit': '1.486', 'ciUpperLimit': '6.849', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.243', 'groupDescription': "Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.871', 'ciLowerLimit': '2.318', 'ciUpperLimit': '10.238', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.846', 'groupDescription': "Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline until week 24', 'description': 'The occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) in main group', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (NCF)'}, {'type': 'SECONDARY', 'title': 'The Occurrence of Relative Efficacy Response in APG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APG: Linagliptin 5mg QD', 'description': 'Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.\n\n(Data up to week 12)'}, {'id': 'OG001', 'title': 'APG: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.\n\n(Data up to week 12)'}], 'classes': [{'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000', 'lowerLimit': '73.6', 'upperLimit': '91.9'}, {'value': '91.2', 'groupId': 'OG001', 'lowerLimit': '81.8', 'upperLimit': '96.7'}]}]}], 'analyses': [{'pValue': '0.2523', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.865', 'ciLowerLimit': '0.642', 'ciUpperLimit': '5.420', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.015', 'groupDescription': "Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline until week 12', 'description': 'The Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 12 Weeks of Treatment) in APG', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (NCF)'}, {'type': 'SECONDARY', 'title': 'The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Main: Linagliptin 5mg QD', 'description': 'Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.'}, {'id': 'OG001', 'title': 'Main: Metformin 500mg BID', 'description': 'Main Group: Patients received metformin 500mg BID, administered oral as tablet.'}, {'id': 'OG002', 'title': 'Main: Metformin 1000mg BID', 'description': 'Main Group: Patients received metformin 1000mg BID, administered oral as tablet.'}, {'id': 'OG003', 'title': 'Main: Linagliptin 2.5mg / Metformin 500mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.'}, {'id': 'OG004', 'title': 'Main: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.03', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '-29.87', 'spread': '2.23', 'groupId': 'OG001'}, {'value': '-42.07', 'spread': '2.31', 'groupId': 'OG002'}, {'value': '-39.33', 'spread': '2.24', 'groupId': 'OG003'}, {'value': '-47.44', 'spread': '2.26', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0971', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.37', 'ciLowerLimit': '-11.72', 'ciUpperLimit': '0.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.23', 'estimateComment': "The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.", 'groupDescription': 'The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.42', 'ciLowerLimit': '-38.67', 'ciUpperLimit': '-26.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.19', 'estimateComment': "The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.", 'groupDescription': 'The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0028', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.47', 'ciLowerLimit': '-15.66', 'ciUpperLimit': '-3.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.16', 'estimateComment': "The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Metformin 500mg BID'.", 'groupDescription': 'The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.31', 'ciLowerLimit': '-30.54', 'ciUpperLimit': '-18.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.17', 'estimateComment': "The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.", 'groupDescription': 'The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 24', 'description': 'The change in fasting plasma glucose (FPG) from baseline after 24 weeks of treatment in main group.\n\nAdjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (LOCF)'}, {'type': 'SECONDARY', 'title': 'The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APG: Linagliptin 5mg QD', 'description': 'Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.\n\n(Data up to week 12)'}, {'id': 'OG001', 'title': 'APG: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.\n\n(Data up to week 12)'}], 'classes': [{'categories': [{'measurements': [{'value': '-56.70', 'spread': '6.53', 'groupId': 'OG000'}, {'value': '-91.92', 'spread': '6.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35.21', 'ciLowerLimit': '-53.48', 'ciUpperLimit': '-16.95', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.23', 'estimateComment': "The adjusted mean difference was calculated as the adjusted mean of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'APG: Linagliptin 5mg QD'.", 'groupDescription': 'The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12', 'description': 'The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG.\n\nAdjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (LOCF)'}, {'type': 'SECONDARY', 'title': 'The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}, {'value': '141', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Main: Linagliptin 5mg QD', 'description': 'Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.'}, {'id': 'OG001', 'title': 'Main: Metformin 500mg BID', 'description': 'Main Group: Patients received metformin 500mg BID, administered oral as tablet.'}, {'id': 'OG002', 'title': 'Main: Metformin 1000mg BID', 'description': 'Main Group: Patients received metformin 1000mg BID, administered oral as tablet.'}, {'id': 'OG003', 'title': 'Main: Linagliptin 2.5mg / Metformin 500mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.'}, {'id': 'OG004', 'title': 'Main: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '12.7'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '6.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '2.7'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '5.0'}, {'value': '2.1', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '6.1'}]}]}], 'analyses': [{'pValue': '0.0271', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.209', 'ciLowerLimit': '0.052', 'ciUpperLimit': '0.838', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.148', 'groupDescription': "Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9699', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.965', 'ciLowerLimit': '0.150', 'ciUpperLimit': '6.202', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.916', 'groupDescription': "Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0343', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.183', 'ciLowerLimit': '0.038', 'ciUpperLimit': '0.882', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.147', 'groupDescription': "Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline until week 24', 'description': "The frequency of patients with use of rescue therapy during 24 week treatment period in main group.\n\nFor this analysis the main group contrast 'Metformin 1000mg BID, Linagliptin 2.5mg / Metformin 1000mg BID' could not be analysed due to lack of events in the Metformin 1000mg BID group.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'APG: Linagliptin 5mg QD', 'description': 'Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.\n\n(Data up to week 12)'}, {'id': 'OG001', 'title': 'APG: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.\n\n(Data up to week 12)'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '19.5'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.9'}]}]}], 'analyses': [{'pValue': '0.0474', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.114', 'ciLowerLimit': '0.013', 'ciUpperLimit': '0.976', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.125', 'groupDescription': "Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.\n\nThe logistic regression includes treatment and continuous baseline HbA1c.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline until week 12', 'description': 'The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Main: Linagliptin 5mg QD', 'description': 'Main Group: Patients received linagliptin 5mg once daily (QD), administered oral as tablet.'}, {'id': 'FG001', 'title': 'Main: Metformin 500mg BID', 'description': 'Main Group: Patients received metformin 500mg twice daily (BID), administered oral as tablet.'}, {'id': 'FG002', 'title': 'Main: Metformin 1000mg BID', 'description': 'Main Group: Patients received metformin 1000mg twice daily (BID), administered oral as tablet.'}, {'id': 'FG003', 'title': 'Main: Linagliptin 2.5mg / Metformin 500mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 500mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.'}, {'id': 'FG004', 'title': 'Main: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.'}, {'id': 'FG005', 'title': 'APG: Linagliptin 5mg QD', 'description': 'Additional parallel group (APG): Patients received linagliptin 5mg once daily (QD), administered oral as tablet.\n\n(Data up to week 12)'}, {'id': 'FG006', 'title': 'APG: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.\n\n(Data up to week 12)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '144'}, {'groupId': 'FG003', 'numSubjects': '147'}, {'groupId': 'FG004', 'numSubjects': '147'}, {'groupId': 'FG005', 'numSubjects': '71'}, {'groupId': 'FG006', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '137'}, {'groupId': 'FG002', 'numSubjects': '127'}, {'groupId': 'FG003', 'numSubjects': '137'}, {'groupId': 'FG004', 'numSubjects': '131'}, {'groupId': 'FG005', 'numSubjects': '64'}, {'groupId': 'FG006', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Non compliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Refused to continue trial medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'After 2-weeks placebo run-in in the main group, 730 of 733 randomised patients were treated in a double-blind fashion for 24 weeks. In the additional parallel group (APG), all of 143 randomised patients with HbA1c \\>=11% were treated for 24 weeks (the first 12 weeks were double-blind). There was a 1-week follow-up period after treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}, {'value': '147', 'groupId': 'BG003'}, {'value': '147', 'groupId': 'BG004'}, {'value': '71', 'groupId': 'BG005'}, {'value': '72', 'groupId': 'BG006'}, {'value': '873', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Main: Linagliptin 5mg QD', 'description': 'Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.'}, {'id': 'BG001', 'title': 'Main: Metformin 500mg BID', 'description': 'Main Group: Patients received metformin 500mg BID, administered oral as tablet.'}, {'id': 'BG002', 'title': 'Main: Metformin 1000mg BID', 'description': 'Main Group: Patients received metformin 1000mg BID, administered oral as tablet.'}, {'id': 'BG003', 'title': 'Main: Linagliptin 2.5mg / Metformin 500mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.'}, {'id': 'BG004', 'title': 'Main: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.'}, {'id': 'BG005', 'title': 'APG: Linagliptin 5mg QD', 'description': 'Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.\n\n(Data up to week 12)'}, {'id': 'BG006', 'title': 'APG: Linagliptin 2.5mg / Metformin 1000mg BID', 'description': 'Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.\n\n(Data up to week 12)'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.8', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '52.1', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '51.4', 'spread': '10.4', 'groupId': 'BG002'}, {'value': '51.4', 'spread': '10.2', 'groupId': 'BG003'}, {'value': '50.7', 'spread': '9.4', 'groupId': 'BG004'}, {'value': '49.5', 'spread': '11.6', 'groupId': 'BG005'}, {'value': '49.9', 'spread': '11.7', 'groupId': 'BG006'}, {'value': '51.0', 'spread': '10.3', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '348', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}, {'value': '48', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}, {'value': '525', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set (TS): all patients treated with at least 1 dose of study medication'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 876}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-08', 'studyFirstSubmitDate': '2012-10-16', 'resultsFirstSubmitDate': '2015-04-08', 'studyFirstSubmitQcDate': '2012-10-16', 'lastUpdatePostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-08', 'studyFirstPostDateStruct': {'date': '2012-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group', 'timeFrame': 'Baseline and week 24', 'description': 'The change from baseline in HbA1c after 24 weeks of treatment in main group.\n\nThe mean was adjusted by baseline HbA1c and treatment group.'}, {'measure': 'The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC)', 'timeFrame': 'Baseline and week 24', 'description': 'The change from baseline in HbA1c after 24 weeks of treatment in main group. Only subjects from the FAS with measured HbA1c values (observed cases \\[OC\\]) were considered.\n\nThe mean was adjusted by treatment, baseline HbA1c, week and treatment\\*week.\n\nThe sensitivity analysis was added as the primary analysis failed with borderline results.'}, {'measure': 'The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG', 'timeFrame': 'Baseline and week 12', 'description': 'The change from baseline in HbA1c after 12 weeks of treatment in additional parallel group (APG)\n\nThe mean was adjusted by baseline HbA1c and treatment group.'}], 'secondaryOutcomes': [{'measure': 'The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 24 Weeks of Treatment in Main Group', 'timeFrame': 'Week 24 (after first drug administration)', 'description': 'The occurrence of treat to target efficacy response in terms of HbA1c \\< 7.0 % after 24 weeks of treatment in main group.'}, {'measure': 'The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 12 Weeks of Treatment in APG', 'timeFrame': 'Week 12 (after first drug administration)', 'description': 'The occurrence of treat to target efficacy response in terms of HbA1c \\< 7.0 % after 12 weeks of treatment in APG.'}, {'measure': 'The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 24 Weeks of Treatment in Main Group', 'timeFrame': 'Week 24 (after first drug administration)', 'description': 'The occurrence of treat to target efficacy response in terms of HbA1c \\< 6.5% after 24 weeks of treatment in main group.'}, {'measure': 'The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 12 Weeks of Treatment in APG', 'timeFrame': 'Week 12 (after first drug administration)', 'description': 'The occurrence of treat to target efficacy response in terms of HbA1c \\< 6.5% after 12 weeks of treatment in APG.'}, {'measure': 'The Occurrence of Relative Efficacy Response in Main Group', 'timeFrame': 'From baseline until week 24', 'description': 'The occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) in main group'}, {'measure': 'The Occurrence of Relative Efficacy Response in APG', 'timeFrame': 'From baseline until week 12', 'description': 'The Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 12 Weeks of Treatment) in APG'}, {'measure': 'The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group', 'timeFrame': 'Baseline and week 24', 'description': 'The change in fasting plasma glucose (FPG) from baseline after 24 weeks of treatment in main group.\n\nAdjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.'}, {'measure': 'The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG', 'timeFrame': 'Baseline and week 12', 'description': 'The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG.\n\nAdjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.'}, {'measure': 'The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group', 'timeFrame': 'From baseline until week 24', 'description': "The frequency of patients with use of rescue therapy during 24 week treatment period in main group.\n\nFor this analysis the main group contrast 'Metformin 1000mg BID, Linagliptin 2.5mg / Metformin 1000mg BID' could not be analysed due to lack of events in the Metformin 1000mg BID group."}, {'measure': 'The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG', 'timeFrame': 'From baseline until week 12', 'description': 'The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '32328953', 'type': 'DERIVED', 'citation': 'Lv Q, Shen J, Miao L, Ye B, Schepers C, Plat A, Shi Y. Early Combination Therapy with Linagliptin and Metformin in People with Type 2 Diabetes Improves Glycemic Control to HbA1c </= 6.5% without Increasing Hypoglycemia: Pooled Analysis of Two Randomized Clinical Trials. Diabetes Ther. 2020 Jun;11(6):1317-1330. doi: 10.1007/s13300-020-00819-9. Epub 2020 Apr 23.'}]}, 'descriptionModule': {'briefSummary': 'Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Diagnosis of Type 2 diabetes mellitus(T2DM) prior to informed consent\n2. Male and female patients on diet and exercise regimen who are drug-naïve\n3. Glycosylated haemoglobin A1c (HbA1c) at V1a \\>/=7.5 %\\<11% for main group and HbA1c \\>/= 11.0 % for the additional parallel group\n4. Age \\>/= 18 and \\</= 80 years at Visit 1a (Screening)\n5. Body Mass Index(BMI)\\</ = 40 kg/m2 at Visit 1a (Screening)\n6. Signed and dated written informed consent by date of Visit 1a in accordance with good clinical practice(GCP) and local legislation\n\nExclusion criteria:\n\n1. Uncontrolled hyperglycaemia required for rescue medication during placebo run-in phase\n2. In main group, the patients with investigational medicinal product(IMP) compliance \\< 80 % or \\>120 % during 2 weeks placebo run in period\n3. Acute coronary syndrome stroke or Transient ischaemic attack (TIA) within 3 months prior to randomisation\n4. Impaired hepatic function, defined by serum levels of either Alanine aminotransferase(ALT) ,Aspartate aminotransferase(AST), or alkaline phosphatase (AP) above 3 x upper limit of normal (ULN) ,or total bilirubin above 1.5 x ULN as determined at Visit 1a\n5. Known hypersensitivity or allergy to linagliptin or its excipients or metformin or placebo\n6. Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening\n7. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator.\n8. Concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form or during the trial.\n9. Pre-menopausal women (last menstruation \\</= 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study\n10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.\n11. Renal failure or renal impairment at Visit 1a (screening) with an Estimated Glomerular Filtration Rate(eGFR) \\< 60 ml/min\n12. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption\n13. Dehydration by clinical judgement of the investigator\n14. Clinical detected unstable or acute congestive heart failure\n15. Acute or chronic metabolic acidosis (present in patient history)\n16. Hereditary galactose intolerance\n17. Known history of pancreatitis and chronic pancreatitis\n18. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within last 5 years.\n19. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial at the discretion of investigator'}, 'identificationModule': {'nctId': 'NCT01708902', 'briefTitle': 'Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase III Randomised, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Fix Dose Combination of Linagliptin 2.5 mg + Metformin 500 mg, or of Linagliptin 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg, Twice Daily), and Linagliptin (5.0 mg, Once Daily) Over 24 Weeks in Treatment naïve Type 2 Diabetic Patients With Insufficient Glycaemic Control', 'orgStudyIdInfo': {'id': '1288.18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'linagliptin2.5mg / metformin500mg BID', 'description': 'patient to receive a tablet containing linagliptin 2.5mg and metformin 500mg BID', 'interventionNames': ['Drug: linagliptin 5mg', 'Drug: Metformin 500mg']}, {'type': 'EXPERIMENTAL', 'label': 'linagliptin2.5mg / metformin1000mg BID', 'description': 'patient to receive a tablet containing linagliptin 2.5mg and metformin 1000mg BID', 'interventionNames': ['Drug: linagliptin 5mg', 'Drug: Metformin 1000mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'metformin 500mg BID', 'description': 'patient to receive a tablet containing metformin 500mg BID', 'interventionNames': ['Drug: linagliptin2.5mg/metformin500mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'metformin 1000mg BID', 'description': 'patient to receive a tablet containing metformin 1000mg BID', 'interventionNames': ['Drug: linagliptin2.5mg/metformin1000mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'linagliptin 5 mg QD', 'description': 'patient to receive a tablet containing linagliptin 5mg once daily', 'interventionNames': ['Drug: linagliptin2.5mg/metformin1000mg', 'Drug: linagliptin2.5mg/metformin500mg']}], 'interventions': [{'name': 'linagliptin2.5mg/metformin1000mg', 'type': 'DRUG', 'description': 'linagliptin2.5mg/metformin1000mg BID', 'armGroupLabels': ['metformin 1000mg BID']}, {'name': 'linagliptin2.5mg/metformin1000mg', 'type': 'DRUG', 'description': 'linagliptin2.5mg/metformin1000mg BID', 'armGroupLabels': ['linagliptin 5 mg QD']}, {'name': 'linagliptin 5mg', 'type': 'DRUG', 'description': 'linagliptin 5mg once daily', 'armGroupLabels': ['linagliptin2.5mg / metformin500mg BID']}, {'name': 'Metformin 500mg', 'type': 'DRUG', 'description': 'Metformin 500mg BID', 'armGroupLabels': ['linagliptin2.5mg / metformin500mg BID']}, {'name': 'linagliptin2.5mg/metformin500mg', 'type': 'DRUG', 'description': 'linagliptin2.5mg/metformin500mg BID', 'armGroupLabels': ['metformin 500mg BID']}, {'name': 'linagliptin2.5mg/metformin500mg', 'type': 'DRUG', 'description': 'linagliptin2.5mg/metformin500mg BID', 'armGroupLabels': ['linagliptin 5 mg QD']}, {'name': 'linagliptin 5mg', 'type': 'DRUG', 'description': 'linagliptin 5mg once daily', 'armGroupLabels': ['linagliptin2.5mg / metformin1000mg BID']}, {'name': 'Metformin 1000mg', 'type': 'DRUG', 'description': 'Metformin 1000mg BID', 'armGroupLabels': ['linagliptin2.5mg / metformin1000mg BID']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': '1288.18.86001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': '1288.18.86002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': '1288.18.86003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 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