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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02636192

CR108054

RRA-15322 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200,000 participants in 2 patient groups

Cohort 1

Description:

Cohort 1 included participants who were exposed to sodium-glucose co-transporter 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin and empagliflozin).

Treatment:

Drug: No Intervention

Cohort 2

Description:

Cohort 2 included participants who were exposed to other non-SGLT2 antihyperglycemic agents (AHA).

Treatment:

Drug: No Intervention