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

AstraZeneca

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01086306

CV181-101

Details and patient eligibility

About

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.

Full 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

Enrollment: 113,505 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

113,505 participants in 2 patient groups

Patients exposed to Saxagliptin

Patients exposed to oral antidiabetic drugs (not Saxagliptin)