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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: No Intervention

• Registration Number: NCT02636192
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-07-31
• Study First Submitted: 2015-12-17
• Study First Submitted QC: 2015-12-17
• Study First Posted: 2015-12-21
• Status Verified: 2017-04
• Primary Completion: 2017-04-07
• Study Completion: 2017-04-07
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200000

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	No Intervention	Cohort 1 included participants who were exposed to sodium-glucose co-transporter 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin and empagliflozin).
Cohort 2	No Intervention	Cohort 2 included participants who were exposed to other non-SGLT2 antihyperglycemic agents (AHA).

Primary Outcome Measures

Name	Time	Method
Number of Participants with a recorded diagnosis of Diabetic Ketoacidosis (DKA)	Day 1