Content uploaded by Gary Meininger
Author content
All content in this area was uploaded by Gary Meininger on May 13, 2016
Content may be subject to copyright.
RESPONSE TO COMMENT ON ERONDU ET AL.
Diabetic Ketoacidosis and Related Events
in the Canagliflozin Type 2 Diabetes
Clinical Program. Diabetes Care
2015;38:1680–1686
Diabetes Care 2016;39:e19 |DOI: 10.2337/dci15-0026
We thank Dr. Dhatariya (1) for his inter-
est in our study that assessed the inci-
dence of serious adverse events of
diabetic ketoacidosis (DKA) and related
events in the canagliflozin type 2 diabe-
tes clinical trial program (2). Our analysi s
of DKA and related events was based
on a standard collection of adverse
event reports from investigators and in-
cluded 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 anal-
ysis. The data included in the article
came from a pooling of studies con-
ducted in more than 50 countries glob-
ally, 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 in-
stitution where the patient was hospital-
ized or the patient not providing medical
release of information). Further prospec-
tive studies are needed to better under-
stand the risk of DKA in patients with
type 2 diabetes treated with canagliflozin.
Dhatariya (1) also raises concerns re-
garding access to primary clinical trial
data. Janssen Research & Development,
LLC (the sponsor of canagliflozin), is com-
mitted to clinical trial data transparency in
order to advance science and medicine
and has an agreement with the Yale Uni-
versity Open Data Access (YODA) Project.
Under the agreement, YODA serves as an
independent body to review and make fi-
nal decisions on requests from physicians
and investigators to access clinical study
reports and anonymized participant-level
data from completed studies (4).
Funding and Duality of Interest. This work
was sponsored by Janssen Research &
Development , LLC. Editorial support was pro-
vided by Kimberly Fuller, PhD, of MedErgy,
andwasfundedbyJanssenGlobalServices,
LLC. Canagliflozin was developed by Janssen Re-
search & Development, LLC, in collaboration
with Mitsubishi Tanabe Pharma Corporation.
N.E., M.D., K.W., and G.M. are full-time em-
ployees of Janssen Research & Development,
LLC. No other potential conflicts of interest rele-
vant to this article were reported.
References
1. Dhatariya K. Comment on Erondu et al. Diabetic
ketoacidosis and related events in the canagliflozin
type 2 diabetes clinical program. Diabetes Care
2015;38:1680–1686 (Letter). Diabetes Care 2016;
39:e18. DOI: 10.2337/dc15-1956
2. Erondu N, Desai M, Ways K, Meininger G.
Diabetic ketoacidosis and related events in the
canagliflozin type 2 diabetes clinical program.
Diabetes Care 2015;38:1680–1686
3. U.S. Department of Health and Human Servic es,
Food and Drug Administration, Center for Drug
Evaluation and Research, Center for Biologics
Evaluation and Research (CBER). Guidance for in-
dustry: good pharmacovigilance practices and
pharmacoepidemiologic assessment [Internet],
2005. Available from http://www.fda.gov/
downloads/RegulatoryInformation/Guidances/
UCM126834.pdf. Accessed 12 October 2015
4. Yale Universit y. The YODA Project [Inter net],
2015. Available from http://yoda.yale.edu/.
Accessed 12 October 2015
Janssen Research & Development, LLC, Raritan, NJ
Corresponding author: Gary Meininger, gmeining@its.jnj.com.
© 2016 by the American Diabe tes Association. Readers may use this article as long as the work is properly cited, t he use is educational and not for profit,
and the work is not altered.
Ngozi Erondu, Mehul Desai, Kirk Ways,
and Gary Meininger
Diabetes Care Volume 39, January 2016 e19
e-LETTERS –COMMENTS AND RE SPONSES
