Post-authorization safety study to assess the risk of diabetic ketoacidosis among type 2 diabetes mellitus patients treated with ertugliflozin compared to patients treated with other antihyperglycemic agents (MK-8835-062)

First published 17/10/2019

Last updated 11/02/2025

EU PAS number:

EUPAS31718

Study

Finalised

Documents

Study protocol

Initial protocol

MK-8835-062-00-v4-Protocol_Final Redaction.pdf

English (3.92 MB - PDF)View document

Updated protocol

MK-8835-062-01-v1-Protocol_final redaction.pdf

First published: 07/02/2025

English (891.27 KB - PDF)View document

Study results

Study report

MK-8835-062-02-interim-report-dec-2022_final redaction

English (1.86 MB - PDF)View document

MK-8835-062-second-interim-report-nov-2022_final redaction

English (1.07 MB - PDF)View document

MK-8835-062-interim-report-dec-2021_final redaction.pdf

English (1.83 MB - PDF)View document

MK-8835-062-final-study-report-AUG-2024_final-redaction.pdf

English (1.25 MB - PDF)View document

Other information

ENCePP Seal

ENCePP Seal documents

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