Clinical trial NCT01086319: Risk of Hospitalization for Severe Hypersensitivity (Including Severe Skin Reactions) in Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
name: University of Pennsylvania
First posted: 2010-03-15
Enrollment: 113505
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be carried out using databases containing administrative claims data (HealthCore Integrated Research DatabaseSM (HIRD) and Medicare in the U.S.) and electronic medical records (General Practice Research Database (GPRD) and The Health Improvement Network (THIN) in the UK). The US population includes patients from health plans in the northeast, southeastern, mid-Atlantic, central, mid-western, and western regions (HIRD) as well as US citizens 65 years of age and older (Medicare). The UK population includes patients seeking medical care from general practitioners (GPRD and THIN)

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

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 12-months
measure: 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)
timeFrame: 18-months
measure: 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)
timeFrame: 36-months
measure: 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)
timeFrame: 54-months
Secondary outcomes:
measure: Hospitalized for anaphylaxis
timeFrame: 12-months
measure: Hospitalized for anaphylaxis
timeFrame: 18-months
measure: Hospitalized for anaphylaxis
timeFrame: 36-months
measure: Hospitalized for anaphylaxis
timeFrame: 54-months
measure: Hospitalized for angioedema
timeFrame: 12-months
measure: Hospitalized for angioedema
timeFrame: 18-months
measure: Hospitalized for angioedema
timeFrame: 36-months
measure: Hospitalized for angioedema
timeFrame: 54-months
measure: Hospitalized for generalized urticaria
timeFrame: 12-months
measure: Hospitalized for generalized urticaria
timeFrame: 18-months
measure: Hospitalized for generalized urticaria
timeFrame: 36-months
measure: Hospitalized for generalized urticaria
timeFrame: 54-months
measure: Hospitalized for severe skin reactions
timeFrame: 12-months
measure: Hospitalized for severe skin reactions
timeFrame: 18-months
measure: Hospitalized for severe skin reactions
timeFrame: 36-months
measure: Hospitalized for severe skin reactions
timeFrame: 54-months
measure: Hospitalized for all endpoints
timeFrame: 12-months
measure: Hospitalized for all endpoints
timeFrame: 18-months
measure: Hospitalized for all endpoints
timeFrame: 36-months
measure: Hospitalized for all endpoints
timeFrame: 54-months
measure: Hospitalized/emergency room (ER) visits for hypersensitivity reactions
timeFrame: 12-months
measure: Hospitalized/emergency room (ER) visits for hypersensitivity reactions
timeFrame: 18-months
measure: Hospitalized/emergency room (ER) visits for hypersensitivity reactions
timeFrame: 36-months
measure: Hospitalized/emergency room (ER) visits for hypersensitivity reactions
timeFrame: 54-months
measure: Death from hypersensitivity reactions
timeFrame: 12-months
measure: Death from hypersensitivity reactions
timeFrame: 18-months
measure: Death from hypersensitivity reactions
timeFrame: 36-months
measure: Death from hypersensitivity reactions
timeFrame: 54-months
measure: Hospitalized for Stevens-Johnson syndrome (SJS)
timeFrame: 12-months
measure: Hospitalized for Stevens-Johnson syndrome (SJS)
timeFrame: 18-months
measure: Hospitalized for Stevens-Johnson syndrome (SJS)
timeFrame: 36-months
measure: Hospitalized for Stevens-Johnson syndrome (SJS)
timeFrame: 54-months
measure: Hospitalized for for toxic epidermal necrolysis (TEN)
timeFrame: 12-months
measure: Hospitalized for for toxic epidermal necrolysis (TEN)
timeFrame: 18-months
measure: Hospitalized for for toxic epidermal necrolysis (TEN)
timeFrame: 36-months
measure: Hospitalized for for toxic epidermal necrolysis (TEN)
timeFrame: 54-months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Lo Re V, Carbonari DM, Saine ME, Newcomb CW, Roy JA, Liu Q, Wu Q, Cardillo S, Haynes K, Kimmel SE, Reese PP, Margolis DJ, Apter AJ, Reddy KR, Hennessy S, Bhullar H, Gallagher AM, Esposito DB, Strom BL. Postauthorization safety study of the DPP-4 inhibitor saxagliptin: a large-scale multinational family of cohort studies of five outcomes. BMJ Open Diabetes Res Care. 2017 Jul 31;5(1):e000400. doi: 10.1136/bmjdrc-2017-000400. eCollection 2017.
citation: Saine ME, Carbonari DM, Newcomb CW, Nezamzadeh MS, Haynes K, Roy JA, Cardillo S, Hennessy S, Holick CN, Esposito DB, Gallagher AM, Bhullar H, Strom BL, Lo Re V 3rd. Determinants of saxagliptin use among patients with type 2 diabetes mellitus treated with oral anti-diabetic drugs. BMC Pharmacol Toxicol. 2015 Apr 2;16:8. doi: 10.1186/s40360-015-0007-z.