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

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ClinicalTrials.gov Identifier: NCT01086319
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : September 20, 2016
Sponsor:
Collaborators:
Bristol-Myers Squibb
University of Pennsylvania
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date March 11, 2010
First Posted Date March 15, 2010
Last Update Posted Date September 20, 2016
Study Start Date August 2009
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2011)
  • 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 54-months ]
Original Primary Outcome Measures
 (submitted: March 12, 2010)
Hospitalizations with any hypersensitivity reaction, including anaphylaxis, angioedema, urticaria, SJS, TEN, and other severe skin reactions (erythema multiforme, acute generalized exanthematous pustulosis, drug rash with eosinophilia/systemic symptoms) [ Time Frame: 52 months ]
Change History
Current Secondary Outcome Measures
 (submitted: April 28, 2011)
  • Hospitalized for anaphylaxis [ Time Frame: 12-months ]
  • Hospitalized for anaphylaxis [ Time Frame: 18-months ]
  • Hospitalized for anaphylaxis [ Time Frame: 36-months ]
  • Hospitalized for anaphylaxis [ Time Frame: 54-months ]
  • Hospitalized for angioedema [ Time Frame: 12-months ]
  • Hospitalized for angioedema [ Time Frame: 18-months ]
  • Hospitalized for angioedema [ Time Frame: 36-months ]
  • Hospitalized for angioedema [ Time Frame: 54-months ]
  • Hospitalized for generalized urticaria [ Time Frame: 12-months ]
  • Hospitalized for generalized urticaria [ Time Frame: 18-months ]
  • Hospitalized for generalized urticaria [ Time Frame: 36-months ]
  • Hospitalized for generalized urticaria [ Time Frame: 54-months ]
  • Hospitalized for severe skin reactions [ Time Frame: 12-months ]
  • Hospitalized for severe skin reactions [ Time Frame: 18-months ]
  • Hospitalized for severe skin reactions [ Time Frame: 36-months ]
  • Hospitalized for severe skin reactions [ Time Frame: 54-months ]
  • Hospitalized for all endpoints [ Time Frame: 12-months ]
  • Hospitalized for all endpoints [ Time Frame: 18-months ]
  • Hospitalized for all endpoints [ Time Frame: 36-months ]
  • Hospitalized for all endpoints [ Time Frame: 54-months ]
  • Hospitalized/emergency room (ER) visits for hypersensitivity reactions [ Time Frame: 12-months ]
  • Hospitalized/emergency room (ER) visits for hypersensitivity reactions [ Time Frame: 18-months ]
  • Hospitalized/emergency room (ER) visits for hypersensitivity reactions [ Time Frame: 36-months ]
  • Hospitalized/emergency room (ER) visits for hypersensitivity reactions [ Time Frame: 54-months ]
  • Death from hypersensitivity reactions [ Time Frame: 12-months ]
  • Death from hypersensitivity reactions [ Time Frame: 18-months ]
  • Death from hypersensitivity reactions [ Time Frame: 36-months ]
  • Death from hypersensitivity reactions [ Time Frame: 54-months ]
  • Hospitalized for Stevens-Johnson syndrome (SJS) [ Time Frame: 12-months ]
  • Hospitalized for Stevens-Johnson syndrome (SJS) [ Time Frame: 18-months ]
  • Hospitalized for Stevens-Johnson syndrome (SJS) [ Time Frame: 36-months ]
  • Hospitalized for Stevens-Johnson syndrome (SJS) [ Time Frame: 54-months ]
  • Hospitalized for for toxic epidermal necrolysis (TEN) [ Time Frame: 12-months ]
  • Hospitalized for for toxic epidermal necrolysis (TEN) [ Time Frame: 18-months ]
  • Hospitalized for for toxic epidermal necrolysis (TEN) [ Time Frame: 36-months ]
  • Hospitalized for for toxic epidermal necrolysis (TEN) [ Time Frame: 54-months ]
Original Secondary Outcome Measures
 (submitted: March 12, 2010)
  • Hospitalized for anaphylaxis [ Time Frame: 12-months, 18-months, 36-months, and 54-months ]
  • Hospitalized for angioedema [ Time Frame: 12-months, 18-months, 36-months, and 54-months ]
  • Hospitalized for urticaria [ Time Frame: 12-months, 18-months, 36-months, and 54-months ]
  • Hospital/ER for Stevens-Johnson syndrome (SJS) [ Time Frame: 12-months, 18-months, 36-months, and 54-months ]
  • Hospital/ER for toxic epidermal necrolysis (TEN) [ Time Frame: 12-months, 18-months, 36-months, and 54-months ]
  • Hospital/ER for other severe skin reactions [ Time Frame: 12-months, 18-months, 36-months, and 54-months ]
  • Hospitalized for all endpoints [ Time Frame: 12-months, 18-months, 36-months, and 54-months ]
  • Hospitalized/ER visits for hypersensitivity reactions [ Time Frame: 12-months, 18-months, 36-months, and 54-months ]
  • Death from hypersensitivity reactions [ Time Frame: 12-months, 18-months, 36-months, and 54-months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
Study Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition Diabetes Mellitus, Type 2
Intervention Not Provided
Study Groups/Cohorts
  • Patients exposed to saxagliptin
  • Patients exposed to oral antidiabetic drugs (not saxagliptin)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 29, 2011)
113505
Original Estimated Enrollment
 (submitted: March 12, 2010)
180000
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01086319
Other Study ID Numbers CV181-103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators
  • Bristol-Myers Squibb
  • University of Pennsylvania
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account AstraZeneca
Verification Date September 2016