Risk of Hospitalization for Severe Hypersensitivity (Including Severe Skin Reactions) in Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments

AstraZeneca

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01086319

CV181-103

Details and patient eligibility

About

The purpose of this study is to compare the incidence hospitalization for severe hypersensitivity and cutaneous reactions among patients with type 2 diabetes who are new users of saxagliptin and those who are new users of other oral antidiabetic drugs.

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 Oral Anti-diabetic Drug (OAD) in a class other than Dipeptidyl peptidase IV (DPP4) inhibitors
• Enrolled in the respective database for at least 180 days prior to first prescription of new OAD
• Have at least one diagnostic code for a type 2 diabetes-related condition

Exclusion criteria

• Patients with an inpatient diagnostic code for any of the conditions of interest within the 180-day baseline period
• Patients prescribed a DPP4 inhibitor during the baseline period

Trial design

113,505 participants in 2 patient groups

Patients exposed to saxagliptin

Patients exposed to oral antidiabetic drugs (not saxagliptin)