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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

Study Description
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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.

Condition or disease
Diabetes Mellitus, Type 2

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 Design
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Study Type : Observational
Actual Enrollment : 113505 participants
Observational Model: Cohort
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 Start Date : August 2009
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Groups and Cohorts
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Group/Cohort
Patients exposed to saxagliptin
Patients exposed to oral antidiabetic drugs (not saxagliptin)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Secondary Outcome Measures :
  1. Hospitalized for anaphylaxis [ Time Frame: 12-months ]
  2. Hospitalized for anaphylaxis [ Time Frame: 18-months ]
  3. Hospitalized for anaphylaxis [ Time Frame: 36-months ]
  4. Hospitalized for anaphylaxis [ Time Frame: 54-months ]
  5. Hospitalized for angioedema [ Time Frame: 12-months ]
  6. Hospitalized for angioedema [ Time Frame: 18-months ]
  7. Hospitalized for angioedema [ Time Frame: 36-months ]
  8. Hospitalized for angioedema [ Time Frame: 54-months ]
  9. Hospitalized for generalized urticaria [ Time Frame: 12-months ]
  10. Hospitalized for generalized urticaria [ Time Frame: 18-months ]
  11. Hospitalized for generalized urticaria [ Time Frame: 36-months ]
  12. Hospitalized for generalized urticaria [ Time Frame: 54-months ]
  13. Hospitalized for severe skin reactions [ Time Frame: 12-months ]
  14. Hospitalized for severe skin reactions [ Time Frame: 18-months ]
  15. Hospitalized for severe skin reactions [ Time Frame: 36-months ]
  16. Hospitalized for severe skin reactions [ Time Frame: 54-months ]
  17. Hospitalized for all endpoints [ Time Frame: 12-months ]
  18. Hospitalized for all endpoints [ Time Frame: 18-months ]
  19. Hospitalized for all endpoints [ Time Frame: 36-months ]
  20. Hospitalized for all endpoints [ Time Frame: 54-months ]
  21. Hospitalized/emergency room (ER) visits for hypersensitivity reactions [ Time Frame: 12-months ]
  22. Hospitalized/emergency room (ER) visits for hypersensitivity reactions [ Time Frame: 18-months ]
  23. Hospitalized/emergency room (ER) visits for hypersensitivity reactions [ Time Frame: 36-months ]
  24. Hospitalized/emergency room (ER) visits for hypersensitivity reactions [ Time Frame: 54-months ]
  25. Death from hypersensitivity reactions [ Time Frame: 12-months ]
  26. Death from hypersensitivity reactions [ Time Frame: 18-months ]
  27. Death from hypersensitivity reactions [ Time Frame: 36-months ]
  28. Death from hypersensitivity reactions [ Time Frame: 54-months ]
  29. Hospitalized for Stevens-Johnson syndrome (SJS) [ Time Frame: 12-months ]
  30. Hospitalized for Stevens-Johnson syndrome (SJS) [ Time Frame: 18-months ]
  31. Hospitalized for Stevens-Johnson syndrome (SJS) [ Time Frame: 36-months ]
  32. Hospitalized for Stevens-Johnson syndrome (SJS) [ Time Frame: 54-months ]
  33. Hospitalized for for toxic epidermal necrolysis (TEN) [ Time Frame: 12-months ]
  34. Hospitalized for for toxic epidermal necrolysis (TEN) [ Time Frame: 18-months ]
  35. Hospitalized for for toxic epidermal necrolysis (TEN) [ Time Frame: 36-months ]
  36. Hospitalized for for toxic epidermal necrolysis (TEN) [ Time Frame: 54-months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086319


Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
University of Pennsylvania
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01086319    
Other Study ID Numbers: CV181-103
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypersensitivity
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Immune System Diseases