Protocol

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

October 17, 2019
Authors:

Harvard Pilgrim Health Care Institute, Reagan-Udall Foundation for FDA, CVS Health, Carelon Research, Humana HealthCare Research, Health Partners Institute, Marshfield Clinic Health System, Vanderbilt University Medical Center, Meyers Primary Care Institute, Optum Epidemiology, Merck Sharp & Dohme LLC

Capability:
Multi-Site Methods & Coordination
Expertise:
Regulatory Research & Support
RWE Research & Consulting
View the public protocol

Merck Sharp & Dohme LLC, Harvard Pilgrim Health Care Institute, Reagan-Udall Foundation for FDA, CVS Health, Carelon Research, Humana HealthCare Research, Health Partners Institute, Marshfield Clinic Health System, Vanderbilt University Medical Center, Meyers Primary Care Institute, Optum Epidemiology. 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) (EUPAS31718; Study ID 50276; MK-8835-062). Amsterdam: European Medicines Agency (EMA); 2019 Oct 17. Available from: https://catalogues.ema.europa.eu/node/3540/administrative-details