This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatment no intervention
Sponsor Janssen Research & Development, LLC
Start date June 2015
End date March 2017
Trial size 400000 participants
Trial identifier NCT02636192, CR108054, RRA-15322


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Cohort 1 included participants who were exposed to sodium-glucose co-transporter 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin and empagliflozin).
no intervention
This is an observational study and participants did not receive any intervention in this study.
Cohort 2 included participants who were exposed to other non-SGLT2 antihyperglycemic agents (AHA).
no intervention
This is an observational study and participants did not receive any intervention in this study.

Primary Outcomes

Number of Participants with a recorded diagnosis of Diabetic Ketoacidosis (DKA)
time frame: Day 1

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Incidence of Diabetic Ketoacidosis Among Patients With Type 2 Diabetes Mellitus Treated With SGLT2 Inhibitors or Other Antihyperglycemic Agents- A Retrospective, Observational, New-User Cohort Study Using 4 Administrative Claims Databases in the US
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Janssen Research & Development, LLC.