We thank Dr. Dhatariya (1) for his interest in our study that assessed the incidence of serious adverse events of diabetic ketoacidosis (DKA) and related events in the canagliflozin type 2 diabetes clinical trial program (2). Our analysis of DKA and related events was based on a standard collection of adverse event reports from investigators and included verbatim terms that map to the specific terms of diabetic ketoacidosis, ketoacidosis, metabolic acidosis, and acidosis from the Medical Dictionary for Regulatory Activities (MedDRA). These methods are in line with the U.S. Food and Drug Administration guidelines on good pharmacovigilance practices, which require investigators to report any adverse event (3). We acknowledge that the amount of data included in case reports of adverse events may vary; however, all available details were included in the published post hoc analysis. The data included in the article came from a pooling of studies conducted in more than 50 countries globally, where access to source data and details contained in the source vary considerably. Occasionally, information was not available for a variety of reasons (e.g., inability of the investigator to obtain detailed source documents from the institution where the patient was hospitalized or the patient not providing medical release of information). Further prospective studies are needed to better understand the risk of DKA in patients with type 2 diabetes treated with canagliflozin.
Dhatariya (1) also raises concerns regarding access to primary clinical trial data. Janssen Research & Development, LLC (the sponsor of canagliflozin), is committed to clinical trial data transparency in order to advance science and medicine and has an agreement with the Yale University Open Data Access (YODA) Project. Under the agreement, YODA serves as an independent body to review and make final decisions on requests from physicians and investigators to access clinical study reports and anonymized participant-level data from completed studies (4).
Article Information
Funding and Duality of Interest. This work was sponsored by Janssen Research & Development, LLC. Editorial support was provided by Kimberly Fuller, PhD, of MedErgy, and was funded by Janssen Global Services, LLC. Canagliflozin was developed by Janssen Research & Development, LLC, in collaboration with Mitsubishi Tanabe Pharma Corporation. N.E., M.D., K.W., and G.M. are full-time employees of Janssen Research & Development, LLC. No other potential conflicts of interest relevant to this article were reported.