Risk of Hospitalization for Severe Hypersensitivity (Including Severe Skin Reactions) in Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT01086319
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113505
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hospitalizations with any hypersensitivity reaction, including anaphylaxis, angioedema, generalized urticaria, SJS, TEN, and other severe skin reactions (i.e., acute generalized exanthematous pustulosis and drug rash with eosinophilia/systemic symptoms) 54-months
- Secondary Outcome Measures
Name Time Method Hospitalized for generalized urticaria 54-months Hospitalized for anaphylaxis 54-months Hospitalized for angioedema 54-months Hospitalized for all endpoints 54-months Hospitalized for severe skin reactions 54-months Death from hypersensitivity reactions 54-months Hospitalized for Stevens-Johnson syndrome (SJS) 54-months Hospitalized/emergency room (ER) visits for hypersensitivity reactions 54-months Hospitalized for for toxic epidermal necrolysis (TEN) 54-months