Risk of Hospitalized Infections Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatment

Comparison of Risk of Hospitalization for Infections Between Patients With Type 2 Diabetes Exposed to Saxagliptin and Those Exposed to Other Oral Anti-Diabetic Treatments

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01086306

Enrollment

113505

Registered

2010-03-15

Start date

2010-01-31

Completion date

2015-12-31

Last updated

2016-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief summary

The purpose of this study is to compare the incidence of hospitalizations for infections among patients with type 2 diabetes mellitus who are new initiators of Saxagliptin and those who are new initiators of Oral Anti-Diabetic Drug (OADs) in classes other than DPP4 inhibitors; and to compare the incidence of hospitalizations with infections associated with T-lymphocyte dysfunction (i.e., herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections \[evaluated as a composite outcome\]) among patients with type 2 diabetes mellitus who are new initiators of Saxagliptin and those who are new initiators of OADs in classes other than DPP4 inhibitors.

Detailed description

Prospectively designed retrospective database study. This study will be conducted using administrative claims data and electronic medical records that are collected as part of routine clinical practice

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years of age or older * Newly prescribed Saxagliptin \[or an OAD in a class other than Dipeptidyl peptidase-4 (DPP4) inhibitors\] * Enrolled in the respective database for at least 180 days prior to the first prescription of new OAD

Exclusion criteria

* Patients identified with a diagnostic code for inpatient diagnostic code for any of the infections of interest within the 180-day baseline period * Patients with DPP4 inhibitor exposure during the baseline period * Patients currently using exenatide or insulin

Design outcomes

Primary

Measure	Time frame	Description
To compare the incidence of hospitalizations for infections among patients with type 2 Diabetes Mellitus who are new initiators of Saxagliptin and those who are new initiators of oral antidiabetic drug (OADs) in classes other than DPP4 inhibitors	18 months	—
To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction	18 months	To compare the incidence of hospitalizations with infections associated with T Lymphocyte dysfunction (i.e., herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections\[evaluated as a composite outcome\]) among patients with type 2 Diabetes Mellitus who are new initiators of Saxagliptin and those who are new initiators of OADs in classes other than DPP4 inhibitors

Secondary

Measure	Time frame
A composite outcome of either inpatient or outpatient diagnoses of herpes zoster, tuberculosis, and non-tuberculous mycobacterial infections plus prescriptions for related antimicrobial therapies	18 months
Inpatient or outpatient diagnoses of herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections (evaluated separately)	18 months
Inpatient diagnoses of respiratory tract infections	18 months

Outcome results