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1 abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical study report had been prepared in accordance with best practice and applicable legal and regulatory requirements at the time of study completion. The synopsis may include approved and non approved uses, doses, formulations, treatment regimens and/or age groups; it has not necessarily been submitted to regulatory authorities. A synopsis is not intended to provide a comprehensive analysis of all data currently available regarding a particular drug. More current information regarding a drug is available in the approved labeling information which may vary from country to country.. Additional information on this study and the drug concerned may be provided upon request based on Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis is supplied for informational purposes only in the interests of scientific disclosure. It must not be used for any commercial purposes and must not be distributed, published, modified, reused, posted in any way, or used for any other purpose without the express written permission of Boehringer Ingelheim.

2 Name of company: Boehringer Ingelheim Name of finished product: Name of active ingredient: Empagliflozin, BI Page: 1 of 5 Tabulated Trial Report ABCD Synopsis No.: Module: Report date: 18 APR 2013 Trial No. / U No.: / U Volume: {hyperlink } Date of trial: 23 APR NOV 2012 Date of revision: Proprietary confidential information 2013 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. Title of trial: A Phase I, open-label, parallel-group study to investigate pharmacokinetics, pharmacodynamics and safety of a single 25 mg dose of Empagliflozin in Japanese type 2 diabetes patients with different degrees of renal impairment in comparison to type 2 diabetes patients with normal renal function Principal/Coordinating Investigator: MD, PhD Trial site: Publication (reference): Clinical phase: Objectives: Methodology: The data of this trial have not been published. I Japan Japan To assess the effect of different degrees of renal impairment on the pharmacokinetics, pharmacodynamics, and safety of empagliflozin after oral administration of 25 mg empagliflozin as a single dose in Japanese patients with type 2 diabetes mellitus Open-label, parallel group study

3 Name of company: Boehringer Ingelheim Name of finished product: Tabulated Trial Report ABCD Name of active ingredient: Empagliflozin, BI Module: Report date: 18 APR 2013 Trial No. / U No.: / U Page: 2 of 5 Volume: {hyperlink } Date of trial: 23 APR NOV 2012 Synopsis No.: Date of revision: Proprietary confidential information 2013 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. No. of patients: planned: actual: Diagnosis and main criteria for inclusion: To be entered: 32 patients (8 per renal function group) enrolled: 51 patients entered: 32 patients Test product: Empagliflozin, BI dose: mode of admin.: Patients with normal renal function (Group 1): entered: 8 treated: 8 analysed: 8 for pharmacokinetic endpoints, 8 for pharmacodynamic endpoint Patients with mild renal impairment (Group 2): entered: 8 treated: 8 analysed: 8 for pharmacokinetic endpoints, 6 for pharmacodynamic endpoint Patients with moderate renal impairment (Group 3): entered: 8 treated: 8 analysed: 8 for pharmacokinetic endpoints, 8 for pharmacodynamic endpoint Patients with severe renal impairment (Group 4): entered: 8 treated: 8 analysed: 8 for pharmacokinetic endpoints, 7 for pharmacodynamic endpoint Type 2 diabetes mellitus Male and female patients with type 2 diabetes mellitus, age 20 to 75 years, falling in the following 4 groups depending on estimated glomerular filtration rate (egfr) calculated by modification of diet in renal disease formula Degree of renal impairment: egfr [ml/min/1.73m 2 ] Normal renal function: 90 (Group 1) Mild renal impairment: 60 to <90 (Group 2) Moderate renal impairment: 30 to <60 (Group 3) Severe renal impairment: 15 to <30 (Group 4) 25 mg Oral, fasted batch no.:

4 Name of company: Boehringer Ingelheim Name of finished product: Tabulated Trial Report ABCD Name of active ingredient: Empagliflozin, BI Module: Report date: 18 APR 2013 Trial No. / U No.: / U Page: 3 of 5 Volume: {hyperlink } Date of trial: 23 APR NOV 2012 Synopsis No.: Date of revision: Proprietary confidential information 2013 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. Reference therapy: dose: mode of admin.: batch no.: Criteria for evaluation: For pharmacokinetics: AUC 0-, C max, AUC 0-tz, %AUC tz-, t max, t 1/2,, MRT po, λ z, CL/F, V z /F, Ae t1-t2, fe t1-t2, CL R,t1-t2, and plasma protein binding of empagliflozin For pharmacodynamics/ Urinary glucose excretion (UGE) for pharmacodynamics and plasma glucose for biomarker: biomarker For Safety: Statistical methods: Adverse events (AEs), laboratory parameters, and vital signs (blood pressure and pulse rate) Analysis of variance model was used for primary pharmacokinetic parameters. Analysis of covariance model was used for primary pharmacodynamic endpoint. Other pharmacokinetic parameters, other pharmacodynamic endpoints, and safety endpoints were analysed descriptively.

5 Name of company: Boehringer Ingelheim Name of finished product: Tabulated Trial Report ABCD Name of active ingredient: Empagliflozin, BI Module: Report date: 18 APR 2013 Trial No. / U No.: / U Page: 4 of 5 Volume: {hyperlink } Date of trial: 23 APR NOV 2012 Synopsis No.: Date of revision: Proprietary confidential information 2013 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. SUMMARY CONCLUSIONS: In total, 32 patients with type 2 diabetes mellitus and with 4 different renal functions were entered in this trial to receive a single dose of empagliflozin 25 mg: 8 patients with normal renal function; 8 patients with mild renal impairment; 8 patients with moderate renal impairment; and 8 patients with severe renal impairment. Of the 32 patients, 23 patients were male and 9 patients were female. The mean age (SD) of all the patients was 65.5 (5.6) years old and the mean body weight (SD) was (8.10) kg. Clinical pharmacology Pharmacokinetics and pharmacodynamics of empagliflozin were evaluated after results: a single oral administration of 25 mg empagliflozin in Japanese patients with type 2 diabetes mellitus and with normal or impaired renal function. Empagliflozin was rapidly absorbed after a single oral administration and reached peak levels at h (median t max ) in patients with normal renal function and those with impaired renal function. Renal impairment had no impact on the peak level (C max ) or t max of empagliflozin. The extent of exposure (AUC 0- ) to empagliflozin increased with increasing degree of renal impairment. The geometric mean ratios (90% confidence interval) of AUC 0- of empagliflozin were approximately 129% ( %) for patients with mild renal impairment; 144% ( %) for patients with moderate renal impairment; and 152% ( %) for patients with severe renal impairment compared with patients with normal renal function. CL/F and V z /F decreased in patients with renal impairment. The mean terminal half-life of empagliflozin was slightly prolonged in patients with moderate renal impairment, but this was not observed in patients with severe renal impairment. No marked effect of renal impairment on protein binding of empagliflozin was observed. Renal impairment had a greater effect on the renal excretion of empagliflozin. The mean fraction of the parent compound excreted in urine was 19.1% in patients with normal renal function; 16.8% in patients with mild renal impairment; 14.6% in patients with moderate renal impairment; and 5.41% in patients with severe renal impairment.

6 Name of company: Boehringer Ingelheim Name of finished product: Tabulated Trial Report ABCD Name of active ingredient: Empagliflozin, BI Module: Report date: 18 APR 2013 Trial No. / U No.: / U Page: 5 of 5 Volume: {hyperlink } Date of trial: 23 APR NOV 2012 Synopsis No.: Date of revision: Proprietary confidential information 2013 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. Pharmacodynamic/ biomarker results: Safety results: Conclusions: A corresponding decrease in UGE was observed with increase in the degree of renal impairment. The adjusted means of total amount of UGE (change from baseline) over 24 h were approximately 75.0 g in patients with normal renal function; 62.6 g in patients with mild renal impairment; 57.9 g in patients with moderate renal impairment; and 23.7 g in patients with severe renal impairment. The decrease in UGE correlated with the decrease in cumulative amount of empagliflozin excreted in urine and the decrease in egfr. Also, the reduction in plasma glucose from baseline tended to decrease with renal impairment and correlated with the decrease in UGE. Adverse events: In this trial, of the 32 patients, only 2 AEs were reported (2 [25.0%]) of the 8 patients with moderate renal impairment). Both AEs were mild in intensity and disappeared without any treatment. A drug-related AE assessed by the investigator was reported for 1 patient (abdominal distension). Serious, severe, or protocol-specified significant AEs were not reported. No death occurred. No patients with laboratory values consistent with a potential Hy s law case were reported. Laboratory parameters and vital signs: There were no clinically significant findings in clinical laboratory evaluation and vital signs. In Japanese patients with type 2 diabetes mellitus and with renal impairment, empagliflozin exposure increased and renal excretion of empagliflozin and glucose decreased with increasing degree of renal impairment. The geometric mean ratio of exposure to empagliflozin reached approximately 152% to the maximum for patients with severe renal impairment compared with patients with normal renal function. On the basis of the pharmacokinetic results, no dose adjustment of empagliflozin was warranted in patients with any degree of renal impairment. After administration of a single oral dose of empagliflozin 25 mg, empagliflozin was safe in Japanese patients with type 2 diabetes mellitus and with different degrees of renal function.

7 Boehringer Ingelheim BI trial number Trial Synopsis - Appendix c Trial Synopsis Appendix The appended tables on the following pages supplement the trial results presented in the Trial Synopsis. They complement primary pharmacokinetic results of the trial. Note that not all secondary endpoints defined in the trial protocol are presented in this synopsis because their number was too large to allow meaningful presentation in this format. Results for presented in C max for Patients with Mild Renal Impairment Table : 2 C max for Patients with Moderate Renal Impairment Table : 2 C max for Patients with Severe Renal Impairment Table : 2 AUC for Patients with Mild Renal Impairment Table : 1 AUC for Patients with Moderate Renal Impairment Table : 1 AUC for Patients with Severe Renal Impairment Table : 1

8 Boehringer Ingelheim Page 448 BI Trial No.: U CTR Main Part Table : 2 Adjusted by treatment geometric means and relative bioavailability comparison Mild : Normal, Treated set Cmax [nmol/l] for BI (PLASMA EDTA) Mild Normal Ratio gse 90% Inter N gmean N gmean Mild : Confidence indiv. Normal interval gcv [%] [%] [%] [%] Source data: Appendix , Statdoc 2 sa\t xpki reports cmax.sas 15JAN2013

9 Boehringer Ingelheim Page 451 BI Trial No.: U CTR Main Part Table : 2 Adjusted by treatment geometric means and relative bioavailability comparison Moderate : Normal, Treated set Cmax [nmol/l] for BI (PLASMA EDTA) Moderate Normal Ratio gse 90% Inter N gmean N gmean Moderate : Confidence indiv. Normal interval gcv [%] [%] [%] [%] Source data: Appendix , Statdoc 4 sa\t xpki reports cmax.sas 15JAN2013

10 Boehringer Ingelheim Page 454 BI Trial No.: U CTR Main Part Table : 2 Adjusted by treatment geometric means and relative bioavailability comparison Severe : Normal, Treated set Cmax [nmol/l] for BI (PLASMA EDTA) Severe Normal Ratio gse 90% Inter N gmean N gmean Severe : Confidence indiv. Normal interval gcv [%] [%] [%] [%] Source data: Appendix , Statdoc 6 sa\t xpki reports cmax.sas 15JAN2013

11 Boehringer Ingelheim Page 447 BI Trial No.: U CTR Main Part Table : 1 Adjusted by treatment geometric means and relative bioavailability comparison Mild : Normal, Treated set AUCinfpred [nmol*h/l] for BI (PLASMA EDTA) Mild Normal Ratio gse 90% Inter N gmean N gmean Mild : Confidence indiv. Normal interval gcv [%] [%] [%] [%] Source data: Appendix , Statdoc 1 sa\t xpki reports auc.sas 15JAN2013

12 Boehringer Ingelheim Page 450 BI Trial No.: U CTR Main Part Table : 1 Adjusted by treatment geometric means and relative bioavailability comparison Moderate : Normal, Treated set AUCinfpred [nmol*h/l] for BI (PLASMA EDTA) Moderate Normal Ratio gse 90% Inter N gmean N gmean Moderate : Confidence indiv. Normal interval gcv [%] [%] [%] [%] Source data: Appendix , Statdoc 3 sa\t xpki reports auc.sas 15JAN2013

13 Boehringer Ingelheim Page 453 BI Trial No.: U CTR Main Part Table : 1 Adjusted by treatment geometric means and relative bioavailability comparison Severe : Normal, Treated set AUCinfpred [nmol*h/l] for BI (PLASMA EDTA) Severe Normal Ratio gse 90% Inter N gmean N gmean Severe : Confidence indiv. Normal interval gcv [%] [%] [%] [%] Source data: Appendix , Statdoc 5 sa\t xpki reports auc.sas 15JAN2013

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