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Supplementary Data SUPPLEMENTARY DATA Supplementary Figure 1—GetGoal-O trial design. *Patients on both insulin and sulfonylurea/glinides were not eligible. eGFR, estimated glomerular filtration rate; FPG, fasting plasma glucose; PPG, postprandial plasma glucose; SMPG, self-monitored plasma glucose. ©2017 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-2143/-/DC1 SUPPLEMENTARY DATA Supplementary Figure 2—Patient disposition in the GetGoal-O trial. ©2017 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-2143/-/DC1 SUPPLEMENTARY DATA Supplementary Figure 3—Change in HbA1c by baseline factors and background antidiabetic therapy from baseline to week 24. eGFR, estimated glomerular filtration rate; OAD, oral antidiabetic drug. ©2017 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-2143/-/DC1 SUPPLEMENTARY DATA Supplementary Figure 4—Incidence of (A) nausea and (B) vomiting by week during the on- treatment period. ©2017 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-2143/-/DC1 SUPPLEMENTARY DATA Supplementary Table 1—Number of patients in the safety population reporting treatment- emergent adverse events Placebo Lixisenatide Patients with: (n = 174) (n = 176) At least one TEAE Any TEAE 118 (67.8) 125 (71.0) Serious TEAE 10 (5.7) 8 (4.5) TEAE leading to death 1 (0.6) 0 (0.0) TEAE leading to discontinuation 10 (5.7) 15 (8.5) AE by organ class Infections and infestations 53 (30.5) 41 (23.3) Nervous system disorders 19 (10.9) 21 (11.9) Gastrointestinal disorders (overall) 36 (20.7) 71 (40.3) Nausea 13 (7.5) 44 (25.0) Vomiting 1 (0.6) 10 (5.7) Diarrhea 13 (7.5) 19 (10.8) Gastrointestinal disorders leading to discontinuation 1 (0.6) 10 (5.7) Musculoskeletal and connective tissue disorders 31 (17.8) 19 (10.8) Arthralgia 8 (4.6) 4 (2.3) Musculoskeletal pain 7 (4.0) 0 (0.0) Hypoglycemia Any hypoglycemia* 18 (10.3) 31 (17.6) Symptomatic hypoglycemia Number of patients with events 10 (5.7) 13 (7.4) Number of events 12 33 Blood glucose <3.3 mmol/L Number of patients with events 10 (5.7) 12 (6.8) Data are presented as n (%) unless stated otherwise. *Symptomatic + asymptomatic (plasma glucose ≤3.9 mmol/L). AE, adverse event; TEAE, treatment-emergent adverse event. ©2017 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-2143/-/DC1 SUPPLEMENTARY DATA Supplementary Table 2—Summary of hypoglycemia with typical symptoms and plasma glucose ≤70 mg/dL (<3.9 mmol/L) during the on-treatment period (safety population) Type Placebo (n = 174) Lixisenatide (n = 176) Total patient years 77.3 76.9 Number of patients with events, n (%) 13 (7.5) 19 (10.8) Number of patients with events per 100 patient-years* 16.81 24.72 Number of events 28 47 Number of events per 100 patient-years† 36.20 61.15 *Calculated as: (number of patients with events × 100 divided by total exposure + 3 days in patient years). †Calculated as (number of events × 100 divided by total exposure + 3 days in patient years). ©2017 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-2143/-/DC1 SUPPLEMENTARY DATA LIST OF PRINCIPAL INVESTIGATOR(S) AND SUB-INVESTIGATOR(S) PER STUDY SITE WHERE PATIENTS WERE ENROLLED QSD-002219 Product Code: AVE0010 Study Code: EFC12703 List of Principal Investigator(s) and Sub-Investigator(s) per study site where patients were enrolled Study Center Professional Investigator last name and first name* Role in the Investigation Institutional Affiliation(s) No. Degree(s) Heidelberg Repatriation Hospital Department of Medicine Building 24, 300 Waterdale Road 036001 Price Sarah Sub-Investigator/Co-Investigator MD Heidelberg 3081 Victoria AUSTRALIA Heidelberg Repatriation Hospital Department of Medicine Building 24, 300 Waterdale Road 036001 Proietto~xr1i Joseph Principal Investigator MD Heidelberg 3081 Victoria AUSTRALIA Heidelberg Repatriation Hospital Department of Medicine Building 24, 300 Waterdale Road Sub-Investigator/Co-Investigator RDC 036001 Sumithran Priyadarsini K. MD Heidelberg Approver 3081 Victoria AUSTRALIA *CV provided as attachment to this appendix for all principal investigators Ensure that the printed copy of this document is the current version available on the Intranet. Property of the sanofi-aventis group - strictly confidential ©2017 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-2143/-/DC1 SUPPLEMENTARY DATA LIST OF PRINCIPAL INVESTIGATOR(S) AND SUB-INVESTIGATOR(S) PER STUDY SITE WHERE PATIENTS WERE ENROLLED QSD-002219 Product Code: AVE0010 Study Code: EFC12703 Study Center Professional Investigator last name and first name* Role in the Investigation Institutional Affiliation(s) No. Degree(s) Heidelberg Repatriation Hospital Department of Medicine Building 24, 300 Waterdale Road Sub-Investigator/Co-Investigator RDC 036001 Sandra Neoh MD Heidelberg Approver 3081 Victoria AUSTRALIA Box Hill Hospital Endocrinology Department Nelson Road 036002 Gilfillan Christopher P. Sub-Investigator/Co-Investigator MD Box Hill 3128 Victoria AUSTRALIA Box Hill Hospital Endocrinology Department Nelson Road 036002 Goh Sue L. Sub-Investigator/Co-Investigator MD Box Hill 3128 Victoria AUSTRALIA *CV provided as attachment to this appendix for all principal investigators Ensure that the printed copy of this document is the current version available on the Intranet. Property of the sanofi-aventis group - strictly confidential ©2017 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-2143/-/DC1 SUPPLEMENTARY DATA LIST OF PRINCIPAL INVESTIGATOR(S) AND SUB-INVESTIGATOR(S) PER STUDY SITE WHERE PATIENTS WERE ENROLLED QSD-002219 Product Code: AVE0010 Study Code: EFC12703 Study Center Professional Investigator last name and first name* Role in the Investigation Institutional Affiliation(s) No. Degree(s) Box Hill Hospital Endocrinology Department Nelson Road 036002 Kalra Balvinder Sub-Investigator/Co-Investigator MD Box Hill 3128 Victoria AUSTRALIA Box Hill Hospital Endocrinology Department Nelson Road 036002 Simpson~xr2i Richard W. Principal Investigator MD Box Hill 3128 Victoria AUSTRALIA Royal Melbourne Hospital Endocrine/Diabetes/Metabolism Grattan Street Sub-Investigator/Co-Investigator RDC 036003 Colman Peter G. MD Parkville Approver 3050 Victoria AUSTRALIA *CV provided as attachment to this appendix for all principal investigators Ensure that the printed copy of this document is the current version available on the Intranet. Property of the sanofi-aventis group - strictly confidential ©2017 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-2143/-/DC1 SUPPLEMENTARY DATA LIST OF PRINCIPAL INVESTIGATOR(S) AND SUB-INVESTIGATOR(S) PER STUDY SITE WHERE PATIENTS WERE ENROLLED QSD-002219 Product Code: AVE0010 Study Code: EFC12703 Study Center Professional Investigator last name and first name* Role in the Investigation Institutional Affiliation(s) No. Degree(s) Royal Melbourne Hospital Endocrine/Diabetes/Metabolism Grattan Street 036003 Fourlanos Spiros Sub-Investigator/Co-Investigator MD Parkville 3050 Victoria AUSTRALIA Royal Melbourne Hospital Endocrine/Diabetes/Metabolism Grattan Street 036003 Nankervis~xr3i Alison J. Principal Investigator MD Parkville 3050 Victoria AUSTRALIA Royal Melbourne Hospital Endocrine/Diabetes/Metabolism Grattan Street 036003 Kvi Mervyn Sub-Investigator/Co-Investigator MD Parkville 3050 Victoria AUSTRALIA *CV provided as attachment to this appendix for all principal investigators Ensure that the printed copy of this document is the current version available on the Intranet. Property of the sanofi-aventis group - strictly confidential ©2017 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-2143/-/DC1 SUPPLEMENTARY DATA LIST OF PRINCIPAL INVESTIGATOR(S) AND SUB-INVESTIGATOR(S) PER STUDY SITE WHERE PATIENTS WERE ENROLLED QSD-002219 Product Code: AVE0010 Study Code: EFC12703 Study Center Professional Investigator last name and first name* Role in the Investigation Institutional Affiliation(s) No. Degree(s) Royal Melbourne Hospital Endocrine/Diabetes/Metabolism Grattan Street 036003 Nguyen Hanh Sub-Investigator/Co-Investigator MD Parkville 3050 Victoria AUSTRALIA Royal Prince Alfred Hospital Diabetes Centre Level 6 West Wing Missenden Road 036004 Ho Jean P. Sub-Investigator/Co-Investigator MD Camperdown 2050 New South Wales AUSTRALIA Royal Prince Alfred Hospital Diabetes Centre Level 6 West Wing Missenden Road 036004 Ross Glynis Sub-Investigator/Co-Investigator MD Camperdown 2050 New South Wales AUSTRALIA *CV provided as attachment to this appendix for all principal investigators Ensure that the printed copy of this document is the current version available on the Intranet. Property of the sanofi-aventis group - strictly confidential ©2017 American Diabetes Association. Published online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-2143/-/DC1 SUPPLEMENTARY DATA LIST OF PRINCIPAL INVESTIGATOR(S) AND SUB-INVESTIGATOR(S) PER STUDY SITE WHERE PATIENTS WERE ENROLLED QSD-002219 Product Code: AVE0010 Study Code: EFC12703 Study Center Professional Investigator last name and first name* Role in the Investigation Institutional Affiliation(s)
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