Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-03 @ 11:10 PM
Study NCT ID:
NCT02489968
Status:
COMPLETED
Last Update Posted:
2018-09-06
First Post:
2015-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Japanese Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}, {'id': 'D000069476', 'term': 'Linagliptin'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "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 till two weeks after last drug administration; up to 72 weeks (including 16 weeks open-label, 2 weeks run-in period and 52 weeks double-blind treatment period).', 'description': 'All patients who were randomised and treated with at least 1 dose of trial drug during open-label and double-blind part of the trial. Adverse events were coded using the MedDRA coding system version 19.1 (Week 24 analysis) and version 20.0 (Week 52 analysis).', 'eventGroups': [{'id': 'EG000', 'title': 'Empagliflozin 25 mg + Linagliptin 5 mg', 'description': 'Patients who received empagliflozin 25 mg during open-label stabilisation period were randomized to receive a FDC tablet of empagliflozin 25 mg and linagliptin 5 mg along with a matching placebo of empagliflozin 25 mg, orally with water, once daily for 52-weeks of double-blind treatment period.', 'otherNumAtRisk': 116, 'otherNumAffected': 54, 'seriousNumAtRisk': 116, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Empagliflozin 10 mg + Linagliptin 5 mg', 'description': 'Patients who received empagliflozin 10 mg during open-label stabilisation period were randomized to receive a fixed dose combination (FDC) tablet of empagliflozin 10 mg and linagliptin 5 mg along with a matching placebo of empagliflozin 10 mg, orally with water, once daily for 24-weeks of double-blind treatment period.', 'otherNumAtRisk': 107, 'otherNumAffected': 24, 'seriousNumAtRisk': 107, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Empagliflozin 25 mg + Placebo', 'description': 'Patients who received empagliflozin 25 mg during open-label stabilisation period were randomized to receive empagliflozin 25 mg along with a matching placebo of the FDC tablet of empagliflozin 25 mg and linagliptin 5 mg, orally with water, once daily for 52-weeks of double-blind treatment period.', 'otherNumAtRisk': 116, 'otherNumAffected': 51, 'seriousNumAtRisk': 116, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Empagliflozin 10 mg + Placebo', 'description': 'Patients who received empagliflozin 10 mg during open-label stabilisation period were randomized to receive empagliflozin 10 mg along with a matching placebo of the FDC tablet of empagliflozin 10 mg and linagliptin 5 mg, orally with water, once daily for 24-weeks of double-blind treatment period.', 'otherNumAtRisk': 108, 'otherNumAffected': 36, 'seriousNumAtRisk': 108, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Empagliflozin 25 mg OL', 'description': 'Patients were administered empagliflozin 25 mg tablets, orally with water, once daily for 16-weeks of open-label stabilisation period.', 'otherNumAtRisk': 440, 'otherNumAffected': 131, 'seriousNumAtRisk': 440, 'seriousNumAffected': 11}, {'id': 'EG005', 'title': 'Empagliflozin 10 mg OL', 'description': 'Patients were administered empagliflozin 10 milligram (mg) tablets, orally with water, once daily for 16-weeks of open-label stabilisation period.', 'otherNumAtRisk': 439, 'otherNumAffected': 120, 'seriousNumAtRisk': 439, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 35}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 30}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood ketone body increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 40}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 46}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 47}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diabetic gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lymphangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Immune thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lateral medullary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ventricular hypokinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Torus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatitis E', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mediastinal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 439, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Glycated Haemoglobin A1c (HbA1c) (%) From Baseline After 24 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Empagliflozin 10 mg + Linagliptin 5 mg', 'description': 'Patients who received empagliflozin 10 mg during open-label stabilisation period were randomized to receive a fixed dose combination (FDC) tablet of empagliflozin 10 mg and linagliptin 5 mg along with a matching placebo of empagliflozin 10 mg, orally with water, once daily for 24-weeks of double-blind treatment period.'}, {'id': 'OG001', 'title': 'Empagliflozin 10 mg + Placebo', 'description': 'Patients who received empagliflozin 10 mg during open-label stabilisation period were randomized to receive empagliflozin 10 mg along with a matching placebo of the FDC tablet of empagliflozin 10 mg and linagliptin 5 mg, orally with water, once daily for 24-weeks of double-blind treatment period.'}, {'id': 'OG002', 'title': 'Empagliflozin 25 mg + Linagliptin 5 mg', 'description': 'Patients who received empagliflozin 25 mg during open-label stabilisation period were randomized to receive a FDC tablet of empagliflozin 25 mg and linagliptin 5 mg along with a matching placebo of empagliflozin 25 mg, orally with water, once daily for 52-weeks of double-blind treatment period.'}, {'id': 'OG003', 'title': 'Empagliflozin 25 mg + Placebo', 'description': 'Patients who received empagliflozin 25 mg during open-label stabilisation period were randomized to receive empagliflozin 25 mg along with a matching placebo of the FDC tablet of empagliflozin 25 mg and linagliptin 5 mg, orally with water, once daily for 52-weeks of double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.94', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '-0.91', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-0.33', 'spread': '0.05', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.82', 'ciLowerLimit': '-0.97', 'ciUpperLimit': '-0.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'estimateComment': 'Adjusted mean difference: Change in HbA1c in (empagliflozin 10 mg + linagliptin 5 mg) - change in HbA1c in (empagliflozin 10 mg + placebo)', 'statisticalMethod': 'REML based MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model including baseline HbA1c, treatment, baseline renal function, prior use of antidiabetic drug, visit, and visit by treatment interaction.'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '-0.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'estimateComment': 'Adjusted mean difference: Change in HbA1c in (empagliflozin 25 mg + linagliptin 5 mg) - change in HbA1c in (empagliflozin 25 mg + placebo)', 'statisticalMethod': 'REML based MMRM', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model including baseline HbA1c, treatment, baseline renal function, prior use of antidiabetic drug, visit, and visit by treatment interaction.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 24 week', 'description': 'Change from baseline in HbA1c (%) after 24 weeks of treatment with double-blind trial medication. Change was calculated as: HbA1c value at 24-week - HbA1c value at baseline, for each patient. Baseline was defined as the last observation before the first intake of double-blind randomised trial medication. Statistical analysis presented is based on a restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach. Full Analysis Set (Observed Cases) \\[FAS (OC)\\]: This analysis set consisted of all patients who were randomised and treated with at least 1 dose of trial drug during the double-blind part of the trial and who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the 24-week double-blind part of the trial. Observed cases analysis included only the available data that were observed while patients were on treatment, i.e., excluding the missing data.', 'unitOfMeasure': 'Percentage (%)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (OC)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Empagliflozin 10 mg OL', 'description': 'Patients were administered empagliflozin 10 milligram (mg) tablets, orally with water, once daily for 16-weeks of open-label stabilisation period.'}, {'id': 'FG001', 'title': 'Empagliflozin 25 mg OL', 'description': 'Patients were administered empagliflozin 25 mg tablets, orally with water, once daily for 16-weeks of open-label stabilisation period.'}, {'id': 'FG002', 'title': 'Empagliflozin 10 mg + Linagliptin 5 mg', 'description': 'Patients who received empagliflozin 10 mg during open-label stabilisation period were randomized to receive a fixed dose combination (FDC) tablet of empagliflozin 10 mg and linagliptin 5 mg along with a matching placebo of empagliflozin 10 mg, orally with water, once daily for 24-weeks of double-blind treatment period.'}, {'id': 'FG003', 'title': 'Empagliflozin 10 mg + Placebo', 'description': 'Patients who received empagliflozin 10 mg during open-label stabilisation period were randomized to receive empagliflozin 10 mg along with a matching placebo of the FDC tablet of empagliflozin 10 mg and linagliptin 5 mg, orally with water, once daily for 24-weeks of double-blind treatment period.'}, {'id': 'FG004', 'title': 'Empagliflozin 25 mg + Linagliptin 5 mg', 'description': 'Patients who received empagliflozin 25 mg during open-label stabilisation period were randomized to receive a FDC tablet of empagliflozin 25 mg and linagliptin 5 mg along with a matching placebo of empagliflozin 25 mg, orally with water, once daily for 52-weeks of double-blind treatment period.'}, {'id': 'FG005', 'title': 'Empagliflozin 25 mg + Placebo', 'description': 'Patients who received empagliflozin 25 mg during open-label stabilisation period were randomized to receive empagliflozin 25 mg along with a matching placebo of the FDC tablet of empagliflozin 25 mg and linagliptin 5 mg, orally with water, once daily for 52-weeks of double-blind treatment period.'}], 'periods': [{'title': 'Open-label Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '439'}, {'comment': '1 subject did not receive treatment and hence excluded. Started represents treated numbers.', 'groupId': 'FG001', 'numSubjects': '440'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '232'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '224'}, {'groupId': 'FG001', 'numSubjects': '208'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other than specified above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '204'}, {'groupId': 'FG001', 'numSubjects': '189'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Double-blind Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '107'}, {'groupId': 'FG003', 'numSubjects': '108'}, {'groupId': 'FG004', 'numSubjects': '116'}, {'groupId': 'FG005', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '105'}, {'groupId': 'FG003', 'numSubjects': '100'}, {'groupId': 'FG004', 'numSubjects': '110'}, {'groupId': 'FG005', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Other than specified above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '880 subjects started the open label period'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'BG000'}, {'value': '433', 'groupId': 'BG001'}, {'value': '868', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Empagliflozin 10 mg OL', 'description': 'Patients were administered empagliflozin 10 milligram (mg) tablets, orally with water, once daily for 16-weeks of open-label stabilisation period.'}, {'id': 'BG001', 'title': 'Empagliflozin 25 mg OL', 'description': 'Patients were administered empagliflozin 25 mg tablets, orally with water, once daily for 16-weeks of open-label stabilisation period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.8', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '57.5', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '57.2', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '324', 'groupId': 'BG000'}, {'value': '309', 'groupId': 'BG001'}, {'value': '633', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Open-label full analysis set (OLFAS) consisted of all patients in the open-label period who received at least 1 dose of open-label study drug during the trial and had a pre-treatment Glycated haemoglobin A1c (HbA1c) assessment and at least 1 on-treatment HbA1c assessment during the open-label part of the trial.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 880}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-03', 'studyFirstSubmitDate': '2015-05-27', 'resultsFirstSubmitDate': '2017-11-16', 'studyFirstSubmitQcDate': '2015-07-01', 'lastUpdatePostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-03', 'studyFirstPostDateStruct': {'date': '2015-07-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glycated Haemoglobin A1c (HbA1c) (%) From Baseline After 24 Weeks of Treatment', 'timeFrame': 'Baseline and 24 week', 'description': 'Change from baseline in HbA1c (%) after 24 weeks of treatment with double-blind trial medication. Change was calculated as: HbA1c value at 24-week - HbA1c value at baseline, for each patient. Baseline was defined as the last observation before the first intake of double-blind randomised trial medication. Statistical analysis presented is based on a restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach. Full Analysis Set (Observed Cases) \\[FAS (OC)\\]: This analysis set consisted of all patients who were randomised and treated with at least 1 dose of trial drug during the double-blind part of the trial and who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the 24-week double-blind part of the trial. Observed cases analysis included only the available data that were observed while patients were on treatment, i.e., excluding the missing data.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '30091172', 'type': 'DERIVED', 'citation': 'Kaku K, Haneda M, Tanaka Y, Lee G, Shiki K, Miyamoto Y, Solimando F, Lee J, Lee C, George J. Linagliptin as add-on to empagliflozin in a fixed-dose combination in Japanese patients with type 2 diabetes: Glycaemic efficacy and safety profile in a two-part, randomized, placebo-controlled trial. Diabetes Obes Metab. 2019 Jan;21(1):136-145. doi: 10.1111/dom.13496. Epub 2018 Sep 6.'}]}, 'descriptionModule': {'briefSummary': 'Two independent study parts (i.e. Part A and Part B) are included in this trial. Part A will evaluate empagliflozin 10 mg + linagliptin and Part B will evaluate empagliflozin 25 mg + linagliptin. All analyses will be carried out separately for these study parts. The objective of Part A is to investigate the efficacy, safety and tolerability of the fixed dose combination (FDC) of empagliflozin 10 mg / linagliptin 5 mg compared with empagliflozin 10 mg plus FDC matching placebo administered orally once daily for 24 weeks in Japanese patients with T2DM (Type 2 Diabetes Mellitus) who have insufficient glycaemic control after 16 weeks of treatment with empagliflozin 10 mg alone once daily. The study is designed to show superiority of the FDC of empagliflozin 10 mg / linagliptin 5 mg over empagliflozin 10 mg plus FDC matching placebo after 24 weeks of treatment. The objective of Part B is to investigate the efficacy, safety and tolerability of the FDC of empagliflozin 25 mg / linagliptin 5 mg compared with empagliflozin 25 mg plus FDC matching placebo administered orally once daily for 24 weeks in Japanese patients with T2DM who have insufficient glycaemic control after 16 weeks of treatment with empagliflozin 25 mg alone once daily. The study is designed to show superiority of the FDC of empagliflozin 25 mg / linagliptin 5 mg over empagliflozin 25 mg plus FDC matching placebo after 24 weeks of treatment. The 24 week treatment period will be followed by a 28 week extension treatment period to evaluate further efficacy and safety up to 52 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Diagnosis of type 2 diabetes prior to informed consent\n* Male and female patients on diet and exercise regimen for at least 12 weeks prior to informed consent who are:\n\n * drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or,\n * pre-treated with one oral antidiabetic drug (for sulfonylurea, with up to half of the maximum approved dose) on stable dosage for at least 12 weeks prior to the informed consent (for thiazolidinedione, therapy has to be unchanged for at least 18 weeks prior to the informed consent). Individual antidiabetic drug will have to be discontinued at Visit 1.\n* haemoglobin A1c (HbA1c) at Visit 1 (screening)\n\n * for patients without antidiabetic therapy : HbA1c \\>=8.0 to =\\<10.5%\n * for patients with one oral antidiabetic drug : HbA1c \\>=7.5 to =\\<10.5%\n* HbA1c \\>=7.5 to =\\<10.0% at Visit 4 for randomisation into the double blind treatment period\n\nExclusion criteria:\n\n* Uncontrolled hyperglycaemia with a glucose level \\>270 mg/dL (\\>15.0 mmol/L) during the open label stabilisation period and placebo run in period\n* Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \\<45 mL/min/1.73m2 (modification of diet in renal disease (MDRD) formula)\n* Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent\n* Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)'}, 'identificationModule': {'nctId': 'NCT02489968', 'briefTitle': 'Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Japanese Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase III, Randomised, Double-blind, Parallel Group, 24-week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and Linagliptin 5 mg Fixed Dose Combination Compared With Empagliflozin 10 mg Plus Placebo and a 52-week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 25 mg and Linagliptin 5 mg Fixed Dose Combination Compared With Empagliflozin 25 mg Plus Placebo in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16-week Treatment With Empagliflozin (10 mg or 25 mg) Alone Once Daily.', 'orgStudyIdInfo': {'id': '1275.13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'empagliflozin 10 mg + linagliptin 5 mg', 'description': 'patient to receive a tablet containing low dose empagliflozin and linagliptin once daily', 'interventionNames': ['Drug: empagliflozin 10 mg + linagliptin 5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'empagliflozin 10 mg', 'description': 'patient to receive a tablet containing low dose empagliflozin once daily', 'interventionNames': ['Drug: empagliflozin 10 mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'empagliflozin 25 mg + linagliptin 5 mg', 'description': 'patient to receive a tablet containing high dose empagliflozin and linagliptin once daily', 'interventionNames': ['Drug: empagliflozin 25 mg + linagliptin 5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'empagliflozin 25 mg', 'description': 'patients to receive a tablet containing high dose empagliflozin once daily', 'interventionNames': ['Drug: empagliflozin 25 mg', 'Drug: Placebo']}], 'interventions': [{'name': 'empagliflozin 10 mg + linagliptin 5 mg', 'type': 'DRUG', 'description': 'empagliflozin low dose + linagliptin once daily', 'armGroupLabels': ['empagliflozin 10 mg + linagliptin 5 mg']}, {'name': 'empagliflozin 10 mg', 'type': 'DRUG', 'description': 'empagliflozin low dose once daily', 'armGroupLabels': ['empagliflozin 10 mg']}, {'name': 'empagliflozin 25 mg + linagliptin 5 mg', 'type': 'DRUG', 'description': 'empagliflozin high dose + linagliptin once daily', 'armGroupLabels': ['empagliflozin 25 mg + linagliptin 5 mg']}, {'name': 'empagliflozin 25 mg', 'type': 'DRUG', 'description': 'empagliflozin high dose once daily', 'armGroupLabels': ['empagliflozin 25 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['empagliflozin 10 mg', 'empagliflozin 25 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '487-0031', 'city': 'Aichi, Kasugai', 'country': 'Japan', 'facility': 'Tokai Memorial Hospital'}, {'zip': '455-8530', 'city': 'Aichi, Nagoya', 'country': 'Japan', 'facility': 'Japan Organization of Occupational Health and Safety Chubu Rosai Hospital'}, {'zip': '261-0004', 'city': 'Chiba, Chiba', 'country': 'Japan', 'facility': 'Tokuyama Clinic'}, {'zip': '790-0067', 'city': 'Ehime, Matsuyama', 'country': 'Japan', 'facility': 'Matsuyama Shimin Hospital', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '792-0045', 'city': 'Ehime, Niihama', 'country': 'Japan', 'facility': 'Tanaka Int. Clinic, Ehime, DIA Med.,CV Med.', 'geoPoint': {'lat': 33.96047, 'lon': 133.30522}}, {'zip': '793-0030', 'city': 'Ehime, Saijo', 'country': 'Japan', 'facility': 'Murakami Memorial Hp., Ehime, I.M.', 'geoPoint': {'lat': 33.91667, 'lon': 133.18333}}, {'zip': '819-0168', 'city': 'Fukuoka, Fukuoka', 'country': 'Japan', 'facility': 'Kunisaki Makoto Clinic, Fukuoka, I.M./CV Med.'}, {'zip': '807-0051', 'city': 'Fukuoka, Onga', 'country': 'Japan', 'facility': 'Fukuoka Shin Mizumaki Hospital'}, {'zip': '824-0026', 'city': 'Fukuoka, Yukuhashi', 'country': 'Japan', 'facility': 'Shin Yukuhashi Hospital'}, {'zip': '500-8225', 'city': 'Gifu, Gifu', 'country': 'Japan', 'facility': 'Hashimoto I.M., Gifu, I.M.'}, {'zip': '370-3573', 'city': 'Gunma, Maebashi', 'country': 'Japan', 'facility': 'Kikuchi Naika Clinic, Gunma, I.M.', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'zip': '066-0032', 'city': 'Hokkaido, Chitose', 'country': 'Japan', 'facility': 'Hasegawa Internal Medicine Clinic', 'geoPoint': {'lat': 42.81944, 'lon': 141.65222}}, {'zip': '067-0041', 'city': 'Hokkaido, Ebetsu', 'country': 'Japan', 'facility': 'Ebetsu Internal Medicine Clinic', 'geoPoint': {'lat': 43.10806, 'lon': 141.55056}}, {'zip': '040-8585', 'city': 'Hokkaido, Hakodate', 'country': 'Japan', 'facility': 'Hakodate Koseiin Hakodate Central General Hospital', 'geoPoint': {'lat': 41.77583, 'lon': 140.73667}}, {'zip': '042-0942', 'city': 'Hokkaido, Hakodate', 'country': 'Japan', 'facility': 'Iida Medical Clinic', 'geoPoint': {'lat': 41.77583, 'lon': 140.73667}}, {'zip': '004-0053', 'city': 'Hokkaido, Sapporo', 'country': 'Japan', 'facility': 'Kurihara Clinic', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '006-0031', 'city': 'Hokkaido, Sapporo', 'country': 'Japan', 'facility': 'Uehara Clinic', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '060-0062', 'city': 'Hokkaido, Sapporo', 'country': 'Japan', 'facility': 'Manda Memorial Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '060-0807', 'city': 'Hokkaido, Sapporo', 'country': 'Japan', 'facility': 'Sapporo Diabetes, Thyroid Clinic', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '062-8618', 'city': 'Hokkaido, Sapporo', 'country': 'Japan', 'facility': 'Japan Community Health Care Organization Hokkaido Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '659-8502', 'city': 'Hyogo, Ashiya', 'country': 'Japan', 'facility': 'Ashiya Municipal Hospital'}, {'zip': '306-0232', 'city': 'Ibaraki, Koga', 'country': 'Japan', 'facility': 'Itabashi DIA Med. and DERM Clinic, Ibaraki, I.M.'}, {'zip': '311-3516', 'city': 'Ibaraki, Namegata', 'country': 'Japan', 'facility': 'Namegata District General Hospital'}, {'zip': '921-8035', 'city': 'Ishikawa, Kanazawa', 'country': 'Japan', 'facility': 'Hokuriku Hp., Ishikawa, I.M.'}, {'zip': '020-0066', 'city': 'Iwate, Morioka', 'country': 'Japan', 'facility': 'Oikawa Clinic'}, {'zip': '020-0132', 'city': 'Iwate, Morioka', 'country': 'Japan', 'facility': 'Hirano Medical Clinic'}, {'zip': '765-0071', 'city': 'Kagawa, Zentsuji', 'country': 'Japan', 'facility': 'Iwamoto Clinic, Kagawa, DIAB I.M.'}, {'zip': '890-0061', 'city': 'Kagoshima, Kagoshima', 'country': 'Japan', 'facility': 'Tenpozan Clinic of I.M., Kagoshima, I.M.'}, {'zip': '253-0044', 'city': 'Kanagawa, Chigasaki', 'country': 'Japan', 'facility': 'Hayashi DIA Clinic, Kanagawa, DIA Tract Med.·I.M.'}, {'zip': '247-0056', 'city': 'Kanagawa, Kamakura', 'country': 'Japan', 'facility': 'Takai Naika Clinic'}, {'zip': '226-0027', 'city': 'Kanagawa, Yokohama', 'country': 'Japan', 'facility': 'Nagatsuta Family Clinic, Kanagawa, I.M.'}, {'zip': '231-0023', 'city': 'Kanagawa, Yokohama', 'country': 'Japan', 'facility': 'Motomachi Takatsuka Naika Clinic, Kanagawa, I.M.'}, {'zip': '232-0064', 'city': 'Kanagawa, Yokohama', 'country': 'Japan', 'facility': 'Yokohama Minoru Clinic'}, {'zip': '860-0863', 'city': 'Kumamoto, Kumamoto', 'country': 'Japan', 'facility': 'Morinagaueno clinic, Kumamoto, Digestive Tract I.M.'}, {'zip': '860-8556', 'city': 'Kumamoto, Kumamoto', 'country': 'Japan', 'facility': 'Kumamoto University Hospital'}, {'zip': '862-0976', 'city': 'Kumamoto, Kumamoto', 'country': 'Japan', 'facility': 'Jinnouchi Clinic Diabetes Care Center'}, {'zip': '615-0035', 'city': 'Kyoto, Kyoto', 'country': 'Japan', 'facility': 'Kajiyama Clinic, Kyoto, I.M.'}, {'zip': '399-0006', 'city': 'Nagano, Matsumoto', 'country': 'Japan', 'facility': 'Matsumoto Nakagawa Hospital'}, {'zip': '380-0802', 'city': 'Nagano, Nagano', 'country': 'Japan', 'facility': 'Ota DIA I.M. Clinic, Nagano, I.M.'}, {'zip': '950-1104', 'city': 'Niigata, Niigata', 'country': 'Japan', 'facility': 'Saiseikai Niigata Daini Hp., Niigata, METAB ENDO'}, {'zip': '708-0841', 'city': 'Okayama, Tsuyama', 'country': 'Japan', 'facility': 'Tsuyama Chuo Hospital'}, {'zip': '900-0032', 'city': 'Okinawa, Naha', 'country': 'Japan', 'facility': 'Yaesu Clinic, Okinawa, I.M.'}, {'zip': '901-0244', 'city': 'Okinawa, Tomigusuku', 'country': 'Japan', 'facility': 'Tanaka Clinic, Okinawa, I.M.'}, {'zip': '530-0001', 'city': 'Osaka', 'country': 'Japan', 'facility': 'AMC Nishi-umeda Clinic', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '582-0005', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Shiraiwa Medical Clinic, Osaka, I.M.', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '530-0057', 'city': 'Osaka, Osaka', 'country': 'Japan', 'facility': 'Umeda Oak Clinic, Osaka, I.M.'}, {'zip': '532-0026', 'city': 'Osaka, Osaka', 'country': 'Japan', 'facility': 'Kinugawa CARDIOL Clinic, Osaka, I.M.'}, {'zip': '536-0008', 'city': 'Osaka, Osaka', 'country': 'Japan', 'facility': 'Ikeoka Clinic, Osaka, I.M.'}, {'zip': '559-0011', 'city': 'Osaka, Osaka', 'country': 'Japan', 'facility': 'Nanko Clinic, Osaka, I.M.'}, {'zip': '565-0853', 'city': 'Osaka, Suita', 'country': 'Japan', 'facility': 'OCROM Clinic'}, {'zip': '849-0917', 'city': 'Saga, Saga', 'country': 'Japan', 'facility': 'Saga Memorial Hospital'}, {'zip': '343-0828', 'city': 'Saitama, Koshigaya', 'country': 'Japan', 'facility': 'Odayaka Life Naika Clinic, Saitama, I.M.'}, {'zip': '363-0022', 'city': 'Saitama, Okegawa', 'country': 'Japan', 'facility': 'Medical corporation Chisei-kai Watanabe clinic'}, {'zip': '350-0233', 'city': 'Saitama, Sakado', 'country': 'Japan', 'facility': 'Medical Corporation Toujinkai Sakado Central Hospital'}, {'zip': '359-1141', 'city': 'Saitama, Tokorozawa', 'country': 'Japan', 'facility': 'SAINO Clinic,'}, {'zip': '430-8525', 'city': 'Shizuoka, Hamamatsu', 'country': 'Japan', 'facility': 'Hamamatsu Rosai Hospital'}, {'zip': '422-8006', 'city': 'Shizuoka, Shizuoka', 'country': 'Japan', 'facility': 'Plumeria Clinic, Shizuoka, I.M.'}, {'zip': '329-0433', 'city': 'Tochigi, Shimotsuke', 'country': 'Japan', 'facility': 'Wakakusa Clinic, Tochigi, I.M.'}, {'zip': '101-0047', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Kanda Clinic, Tokyo, I.M.', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '103-0025', 'city': 'Tokyo, Chuo-ku', 'country': 'Japan', 'facility': 'Nihonbashi Sakura Clinic'}, {'zip': '103-0027', 'city': 'Tokyo, Chuo-ku', 'country': 'Japan', 'facility': 'Fukuwa Clinic'}, {'zip': '103-0027', 'city': 'Tokyo, Chuo-ku', 'country': 'Japan', 'facility': 'Nihonbashi Enomoto Internal Medicine'}, {'zip': '103-0027', 'city': 'Tokyo, Chuo-ku', 'country': 'Japan', 'facility': 'Tokyo-Eki Center-building Clinic'}, {'zip': '103-0028', 'city': 'Tokyo, Chuo-ku', 'country': 'Japan', 'facility': 'Tokyo Center Clinic'}, {'zip': '104-0031', 'city': 'Tokyo, Chuo-ku', 'country': 'Japan', 'facility': 'Hosono Clinic'}, {'zip': '104-0061', 'city': 'Tokyo, Chuo-ku', 'country': 'Japan', 'facility': 'AGE Makita Medical Clinic'}, {'zip': '134-0084', 'city': 'Tokyo, Edogawa-ku', 'country': 'Japan', 'facility': 'Kasai Diabetes Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '192-0046', 'city': 'Tokyo, Hachioji', 'country': 'Japan', 'facility': 'New Medical Research System Clinic'}, {'zip': '192-0071', 'city': 'Tokyo, Hachioji', 'country': 'Japan', 'facility': 'Medical Corporation Keikokai P1-Clinic'}, {'zip': '192-0918', 'city': 'Tokyo, Hachioji', 'country': 'Japan', 'facility': 'Minamino Heart Clinic'}, {'zip': '124-0024', 'city': 'Tokyo, Katushika-ku', 'country': 'Japan', 'facility': 'Shinkoiwa Ekimae Sougou Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '204-0021', 'city': 'Tokyo, Kiyose', 'country': 'Japan', 'facility': 'Musashino Polyclinic'}, {'zip': '105-7390', 'city': 'Tokyo, Minato-ku', 'country': 'Japan', 'facility': 'Pedi Shiodome Clinic'}, {'zip': '108-0075', 'city': 'Tokyo, Minato-ku', 'country': 'Japan', 'facility': 'Shinagawa East one Medical Clinic'}, {'zip': '177-0051', 'city': 'Tokyo, Nerima-ku', 'country': 'Japan', 'facility': 'Shimamura Kinen Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '143-0015', 'city': 'Tokyo, Ota-ku', 'country': 'Japan', 'facility': 'Kenkoukan Suzuki Clinic'}, {'zip': '143-0023', 'city': 'Tokyo, Ota-ku', 'country': 'Japan', 'facility': 'Honda Hidehiko Clinic'}, {'zip': '140-0011', 'city': 'Tokyo, Shinagawa-ku', 'country': 'Japan', 'facility': 'Sakayori Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '141-0032', 'city': 'Tokyo, Shinagawa-ku', 'country': 'Japan', 'facility': 'Miho Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '160-0022', 'city': 'Tokyo, Shinjuku-ku', 'country': 'Japan', 'facility': 'ToCROM Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '171-0021', 'city': 'Tokyo, Toshima-ku', 'country': 'Japan', 'facility': 'Ikebukuro Metropolitan Clinic', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '930-0964', 'city': 'Toyama, Toyama', 'country': 'Japan', 'facility': 'Fujikoshi Hp., Toyama, I.M.'}, {'zip': '990-0885', 'city': 'Yamagata, Yamagata', 'country': 'Japan', 'facility': 'Clinic Sugiyama, Yamagata, I.M.'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}