Status: Ongoing First registered on: 17/10/2019
Last updated on: 09/09/2020
1. Study identification
EU PAS Register NumberEUPAS31718
Official titlePost-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
Study title acronymMK-8835-062
Study typeObservational study
Brief description of the studyA non-interventional cohort study will be conducted using the Reagan-Udall Foundation for the Food and Drug Administration (FDA)’s Innovation in Medical Evidence and Development Surveillance Distributed Database (IMEDS-DD), a subset of the FDA Sentinel Distributed Database. This study will address the research question of whether new use of ertugliflozin is associated with an increased risk of diabetic ketoacidosis (DKA), compared to new use of other non-sodium–glucose cotransporter 2 (SGLT2) inhibitor antihyperglycemic agents (AHAs) among type 2 diabetes mellitus (T2DM) patients. Propensity score matching will be used for confounding adjustment, followed by Cox proportional hazards models for risk estimation.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameReagan-Udall Foundation for the Food and Drug Administration
Centre locationWashington, DC, U.S.A
Details of (Primary) lead investigator
Title Dr
Last name Brown
First name Jeffrey
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed03/07/2018
Start date of data collection24/10/201917/10/2019
Start date of data analysis31/07/2023
Date of interim report, if expected31/12/2021
Date of final study report31/12/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMerck Sharp & Dohme, Corp.60
Charities
Government body
Research councils
EU funding scheme
OtherPfizer Inc.40
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Merck Sharp & Dohme Corp.
First name Clinical Trials Disclosure
Address line 12000 Galloping Hill Road
Address line 2 
Address line 3 
CityKenilworth, N.J. 
Postcode07033 
CountryUnited States
Phone number (incl. country code)1-7325941816 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Merck Sharp & Dohme Corp. 
First name Clinical Trials Disclosure 
Address line 12000 Galloping Hill Road 
Address line 2 
Address line 3 
CityKenilworth, N.J. 
Postcode07033 
CountryUnited States 
Phone number (incl. country code)1-7325941816 
Alternative phone number 
Fax number (incl. country code) 
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