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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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
AstraZeneca
University of Pennsylvania
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01086319
First received: March 11, 2010
Last updated: December 29, 2011
Last verified: December 2011
History of Changes
  Purpose

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
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Drug Information available for: Saxagliptin
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hospitalized for anaphylaxis [ Time Frame: 12-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for anaphylaxis [ Time Frame: 18-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for anaphylaxis [ Time Frame: 36-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for anaphylaxis [ Time Frame: 54-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for angioedema [ Time Frame: 12-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for angioedema [ Time Frame: 18-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for angioedema [ Time Frame: 36-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for angioedema [ Time Frame: 54-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for generalized urticaria [ Time Frame: 12-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for generalized urticaria [ Time Frame: 18-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for generalized urticaria [ Time Frame: 36-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for generalized urticaria [ Time Frame: 54-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for severe skin reactions [ Time Frame: 12-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for severe skin reactions [ Time Frame: 18-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for severe skin reactions [ Time Frame: 36-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for severe skin reactions [ Time Frame: 54-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for all endpoints [ Time Frame: 12-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for all endpoints [ Time Frame: 18-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for all endpoints [ Time Frame: 36-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for all endpoints [ Time Frame: 54-months ] [ Designated as safety issue: Yes ]
  • Hospitalized/emergency room (ER) visits for hypersensitivity reactions [ Time Frame: 12-months ] [ Designated as safety issue: Yes ]
  • Hospitalized/emergency room (ER) visits for hypersensitivity reactions [ Time Frame: 18-months ] [ Designated as safety issue: Yes ]
  • Hospitalized/emergency room (ER) visits for hypersensitivity reactions [ Time Frame: 36-months ] [ Designated as safety issue: Yes ]
  • Hospitalized/emergency room (ER) visits for hypersensitivity reactions [ Time Frame: 54-months ] [ Designated as safety issue: Yes ]
  • Death from hypersensitivity reactions [ Time Frame: 12-months ] [ Designated as safety issue: Yes ]
  • Death from hypersensitivity reactions [ Time Frame: 18-months ] [ Designated as safety issue: Yes ]
  • Death from hypersensitivity reactions [ Time Frame: 36-months ] [ Designated as safety issue: Yes ]
  • Death from hypersensitivity reactions [ Time Frame: 54-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for Stevens-Johnson syndrome (SJS) [ Time Frame: 12-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for Stevens-Johnson syndrome (SJS) [ Time Frame: 18-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for Stevens-Johnson syndrome (SJS) [ Time Frame: 36-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for Stevens-Johnson syndrome (SJS) [ Time Frame: 54-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for for toxic epidermal necrolysis (TEN) [ Time Frame: 12-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for for toxic epidermal necrolysis (TEN) [ Time Frame: 18-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for for toxic epidermal necrolysis (TEN) [ Time Frame: 36-months ] [ Designated as safety issue: Yes ]
  • Hospitalized for for toxic epidermal necrolysis (TEN) [ Time Frame: 54-months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 113505
Study Start Date: January 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients exposed to saxagliptin
Patients exposed to oral antidiabetic drugs (not saxagliptin)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01086319

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

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01086319     History of Changes
Other Study ID Numbers: CV181-103
Study First Received: March 11, 2010
Last Updated: December 29, 2011
Health Authority: United States: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypersensitivity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Immune System Diseases
Saxagliptin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013