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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients exposed to saxagliptin<br> | |
| Patients exposed to oral antidiabetic drugs (not saxagliptin)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| 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) |  | 18-months | 
| 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) |  | 36-months | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalized for anaphylaxis |  | 12-months | 
| Hospitalized for anaphylaxis |  | 18-months | 
| Hospitalized for anaphylaxis |  | 36-months | 
| Hospitalized for anaphylaxis |  | 54-months | 
| Hospitalized for angioedema |  | 12-months | 
| Hospitalized for angioedema |  | 18-months | 
| Hospitalized for angioedema |  | 36-months | 
| Hospitalized for angioedema |  | 54-months | 
| Hospitalized for generalized urticaria |  | 12-months | 
| Hospitalized for generalized urticaria |  | 18-months | 
| Hospitalized for generalized urticaria |  | 36-months | 
| Hospitalized for generalized urticaria |  | 54-months | 
| Hospitalized for severe skin reactions |  | 12-months | 
| Hospitalized for severe skin reactions |  | 18-months | 
| Hospitalized for severe skin reactions |  | 36-months | 
| Hospitalized for severe skin reactions |  | 54-months | 
| Hospitalized for all endpoints |  | 12-months | 
| Hospitalized for all endpoints |  | 18-months | 
| Hospitalized for all endpoints |  | 36-months | 
| Hospitalized for all endpoints |  | 54-months | 
| Hospitalized/emergency room (ER) visits for hypersensitivity reactions |  | 12-months | 
| Hospitalized/emergency room (ER) visits for hypersensitivity reactions |  | 18-months | 
| Hospitalized/emergency room (ER) visits for hypersensitivity reactions |  | 36-months | 
| Hospitalized/emergency room (ER) visits for hypersensitivity reactions |  | 54-months | 
| Death from hypersensitivity reactions |  | 12-months | 
| Death from hypersensitivity reactions |  | 18-months | 
| Death from hypersensitivity reactions |  | 36-months | 
| Death from hypersensitivity reactions |  | 54-months | 
| Hospitalized for Stevens-Johnson syndrome (SJS) |  | 12-months | 
| Hospitalized for Stevens-Johnson syndrome (SJS) |  | 18-months | 
| Hospitalized for Stevens-Johnson syndrome (SJS) |  | 36-months | 
| Hospitalized for Stevens-Johnson syndrome (SJS) |  | 54-months | 
| Hospitalized for for toxic epidermal necrolysis (TEN) |  | 12-months | 
| Hospitalized for for toxic epidermal necrolysis (TEN) |  | 18-months | 
| Hospitalized for for toxic epidermal necrolysis (TEN) |  | 36-months | 
| Hospitalized for for toxic epidermal necrolysis (TEN) |  | 54-months |