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Completed

NCT Number: NCT01086319

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb
  • University of Pennsylvania

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Mar 15, 2010
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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