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

Comparison of Risk of Hospitalization for Severe Hypersensitivity (Including Severe Cutaneous Reactions) Between Patients With Type 2 Diabetes Initiating Saxagliptin and Those Initiating Other Oral Antidiabetic Treatments

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01086319

Enrollment

113505

Registered

2010-03-15

Start date

2009-08-31

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 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

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 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

Design outcomes

Primary

Measure	Time frame
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)	12-months

Secondary

Measure	Time frame
Hospitalized for angioedema	12-months
Hospitalized for generalized urticaria	12-months
Hospitalized for severe skin reactions	12-months
Hospitalized for all endpoints	12-months
Hospitalized for anaphylaxis	12-months
Death from hypersensitivity reactions	12-months
Hospitalized for Stevens-Johnson syndrome (SJS)	12-months
Hospitalized for for toxic epidermal necrolysis (TEN)	12-months
Hospitalized/emergency room (ER) visits for hypersensitivity reactions	12-months

Outcome results