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
This trial is active, not recruiting.
|Condition||diabetes mellitus, type 2|
|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.
Number of Participants with a recorded diagnosis of Diabetic Ketoacidosis (DKA)
time frame: Day 1
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.
|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.|
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