Study on Incidence of Diabetic Ketoacidosis Among Participants With Type 2 Diabetes Mellitus Treated With Sodium-glucose Co-transporter 2 (SGLT2) Inhibitors or Other Antihyperglycemic Agents
Study on Incidence of Diabetic Ketoacidosis Among Participants With Type 2 Diabetes Mellitus Treated With Sodium-glucose Co-transporter 2 (SGLT2) Inhibitors or Other Antihyperglycemic Agents
The purpose of this study is to compare the incidence of diabetic ketoacidosis (DKA) among
 participants diagnosed with type 2 diabetes mellitus (T2DM) and pair-matched on exposure
 propensity scores for new use of any sodium-glucose co-transporter 2 inhibitors (SGLT2i)
 versus new use of various other antihyperglycemic agents (AHAs), combined as one group.
This study will be an overall retrospective, observational, new-user cohort study using 4
 large administrative claims databases in the US. Participants diagnosed with T2DM and
 initiated on SGLT2i or other AHAs (metformin, sulfonylureas (SU), thiazolidinediones (TZDs),
 DPP-4 inhibitors (DPP4i), GLP-1 agonists, insulin, and other AHAs) between April 1, 2013 and
 the end of claims data availability will be included in the study and will be estimated for
 incidence rates of DKA in the different AHA new-user groups.
Inclusion Criteria:

 -  At least 1 antihyperglycemic agents (AHA) prescription (Rx) during the study period,
 between 4/1/2013 and 9/30/2014.

 -  Diagnosed of type 2 diabetes mellitus

 -  Enrollment history of at least 12 months

 -  Having prescription drug coverage

 -  Having no prescription of the index drug during the 6 months prior

 Exclusion Criteria:

 - Participants who receive diagnosis of type1 diabetes mellitus (T1DM) and/or secondary
 diabetes mellitus (SDM) any time after index date.