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Protocol for Non-Interventional Studies Based on Existing Data TITLE PAGE ABCD TITLE PAGE Protocol for non-interventional studies based on existing data TITLE PAGE Document Number: c12992044-01 BI Study Number: 1218.178 BI Investigational Trazenta (Linagliptin) Product(s): Title: Clinical characteristics and practice patterns of type 2 diabetes mellitus (T2DM) patients treated with oral antidiabetic drugs (OAD) in Japan: analysis of medical and health care database of the Medical Data Vision (MDV) Protocol version Version 1 identifier: Date of last version of Not Applicable protocol: PASS: No EU PAS register Not Applicable number: Active substance: Linagliptin Medicinal product: Trazenta Product reference: Not applicable Procedure number: Not applicable Joint PASS: No Research question and To understand the prescription pattern in T2DM patients of each objectives: compound and each class for all OADs, available throughout study period. Country(-ies) of study: Japan Author: Marketing authorisation Nippon Boehringer Ingelheim Co,, Ltd. holder(s): 2-1-1, Osaki, Shinagawa-ku, Tokyo 141-6017, Japan 001-MCS-90-124_RD-01 (4.0) Boehringer Ingelheim Page 2 of 32 Protocol for non-interventional studies based on existing data BI Study Number 1218.178 c12992044-01 Proprietary confidential information © 2017 Boehringer Ingelheim International GmbH or one or more of its affiliated companies MAH contact person: Clinical Development and Medical Affairs Nippon Boehringer Ingelheim Co., Ltd. 2-1-1, Osaki, Shinagawa-ku, Tokyo 141-6017, Japan In case of PASS, add: Not Applicable <EU-QPPV:> In case of PASS, add: Not Applicable <Signature of EU- QPPV:> Date: 09 February 2017 Page 1 of 32 Proprietary confidential information © 2017 Boehringer Ingelheim International GmbH or one or more of its affiliated companies. All rights reserved. This document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written permission 001-MCS-90-124_RD-01 (4.0) Boehringer Ingelheim Page 3 of 32 Protocol for non-interventional studies based on existing data BI Study Number 1218.178 c12992044-01 Proprietary confidential information © 2017 Boehringer Ingelheim International GmbH or one or more of its affiliated companies 1. TABLE OF CONTENTS TITLE PAGE .................................................................................................................. 1 1. TABLE OF CONTENTS....................................................................................... 3 2. LIST OF ABBREVIATIONS................................................................................ 5 3. RESPONSIBLE PARTIES.................................................................................... 6 4. ABSTRACT........................................................................................................... 7 5. AMENDMENTS AND UPDATES..................................................................... 13 6. MILESTONES..................................................................................................... 14 7. RATIONALE AND BACKGROUND................................................................ 15 8. RESEARCH QUESTION AND OBJECTIVES ................................................. 17 9. RESEARCH METHODS .................................................................................... 18 9.1 STUDY DESIGN............................................................................................ 18 9.2 SETTING ........................................................................................................ 19 9.3 VARIABLES .................................................................................................. 20 9.3.1 Exposures ................................................................................................ 20 9.3.2 Outcomes................................................................................................. 21 9.3.2.1 Primary outcomes..................................................................................21 9.3.2.2 Secondary outcomes..............................................................................21 ...................................................................................21 9.3.3 Covariates................................................................................................ 21 9.4 DATA SOURCES........................................................................................... 22 9.5 STUDY SIZE.................................................................................................. 22 9.6 DATA MANAGEMENT................................................................................ 22 9.7 DATA ANALYSIS......................................................................................... 22 9.7.1 Main analysis........................................................................................... 22 ....................................................................................... 23 9.8 QUALITY CONTROL................................................................................... 24 9.9 LIMITATIONS OF THE RESEARCH METHODS...................................... 24 9.10 OTHER ASPECTS ......................................................................................... 24 9.11 SUBJECTS...................................................................................................... 24 9.11.1 Cases........................................................................................................ 24 9.11.2 Controls ................................................................................................... 24 9.12 BIAS................................................................................................................ 24 10. PROTECTION OF HUMAN SUBJECTS .......................................................... 26 001-MCS-90-124_RD-01 (4.0) Boehringer Ingelheim Page 4 of 32 Protocol for non-interventional studies based on existing data BI Study Number 1218.178 c12992044-01 Proprietary confidential information © 2017 Boehringer Ingelheim International GmbH or one or more of its affiliated companies 11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS....................................................................................................... 27 12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS............................................................................................................ 28 13. REFERENCES .................................................................................................... 29 13.1 PUBLISHED REFERENCES......................................................................... 29 13.2 UNPUBLISHED REFERENCES................................................................... 29 ANNEX 1. LIST OF STAND-ALONE DOCUMENTS.............................................. 30 ANNEX 2. ENCEPP CECKLIST FOR STUDY PROTOCOLS ................................. 31 ANNEX 3. ADDITIONAL INFORMATION.............................................................. 32 001-MCS-90-124_RD-01 (4.0) Boehringer Ingelheim Page 5 of 32 Protocol for non-interventional studies based on existing data BI Study Number 1218.178 c12992044-01 Proprietary confidential information © 2017 Boehringer Ingelheim International GmbH or one or more of its affiliated companies 2. LIST OF ABBREVIATIONS AE Adverse Event CI Confidence Interval EudraCT European Clinical Trials Database FAS Full Analysis Set IEC Independent Ethics Committee IRB Institutional Review Board i.v. Intravenous MedDRA Medical Dictionary for Drug Regulatory Activities OAD Oral Antidiabetic Drugs OPU Operative Unit p.o. per os (oral) q.d. quaque die (once a day) SAE Serious Adverse Event s.c. Subcutaneous T2DM Type 2 Diabetes Mellitus TCM Trial Clinical Monitor t.i.d. ter in die (3 times a day) TMM Team Member Medicine 001-MCS-90-124_RD-01 (4.0) Boehringer Ingelheim Page 6 of 32 Protocol for non-interventional studies based on existing data BI Study Number 1218.178 c12992044-01 Proprietary confidential information © 2017 Boehringer Ingelheim International GmbH or one or more of its affiliated companies 3. RESPONSIBLE PARTIES • Medical Advisor Department of Diabetes and Metabolic Diseases Graduate School of Medicine The University of Tokyo Drug Development & Regulatory Science Faculty of Pharmacy Keio University • Person responsible for trial (Alphabetic order in each affiliation) Clinical Development and Medical Affairs Nippon Boehringer Ingelheim Co., Ltd. 2-1-1, Osaki, Shinagawa-ku, Tokyo 141-6017, Japan (Alliance partner) Diabetes products, Medicine Development Unit Japan Eli Lilly Japan K.K. 4-15-1, Akasaka, Minato-ku, Tokyo 107-0052, Japan (Statistics/Data analysis) (Statistics/Data analysis) Japan Healthcare Practice and Data Analytics Milliman, Inc. 1-6-2, Kojimachi, Chiyoda-ku, Tokyo 102-0083, Japan 001-MCS-90-124_RD-01 (4.0) Boehringer Ingelheim Page 7 of 32 Protocol for non-interventional studies based on existing data BI Study Number 1218.178 c12992044-01 Proprietary confidential information © 2017 Boehringer Ingelheim International GmbH or one or more of its affiliated companies 4. ABSTRACT Name of company: Boehringer Ingelheim Name of finished medicinal product: If applicable, list centrally-authorised medicinal product(s) subject to the study. Trazenta Name of active ingredient: List pharmacotherapeutic A10N,A10H,A10J,A10K,A10L group(s){ACT codes} and active substance(s) subject to the study A10M Protocol date: Study Version/Revision: Version/Revision number: date: 09 February 2017 1218.178 1.0 Title of study: Clinical characteristics
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