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NCT02636192 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02636192
Other study ID # CR108054
Secondary ID RRA-15322
Status Completed
Phase N/A
First received December 17, 2015
Last updated April 12, 2017
Start date July 31, 2015
Est. completion date April 7, 2017

Study information
Verified date April 2017
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200000
Est. completion date April 7, 2017
Est. primary completion date April 7, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• No Intervention
This is an observational study and participants did not receive any intervention in this study.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Janssen Research & Development, LLC

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with a recorded diagnosis of Diabetic Ketoacidosis (DKA) Day 1
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