Study identification

PURI

https://redirect.ema.europa.eu/resource/50276

EU PAS number

EUPAS31718

Study ID

50276

Official title and acronym

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)

DARWIN EU® study

No

Study countries

United States

Study description

A 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.

Study status

Finalised
Research institution and networks

Institutions

Contact details

Sengwee Toh

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other
Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC, Pfizer Inc.
Study protocol
Initial protocol

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

English (891.27 KB - PDF)View document
Updated protocol

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

English (3.92 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)