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

Tracking Information

First Received Date ^ICMJE

March 11, 2010

Last Updated Date

December 29, 2011

Start Date ^ICMJE

January 2010

Estimated Primary Completion Date

April 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01086319 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Hospitalized for anaphylaxis [ Time Frame: 12-months, 18-months, 36-months, and 54-months ] [ Designated as safety issue: Yes ]
Hospitalized for angioedema [ Time Frame: 12-months, 18-months, 36-months, and 54-months ] [ Designated as safety issue: Yes ]
Hospitalized for urticaria [ Time Frame: 12-months, 18-months, 36-months, and 54-months ] [ Designated as safety issue: Yes ]
Hospital/ER for Stevens-Johnson syndrome (SJS) [ Time Frame: 12-months, 18-months, 36-months, and 54-months ] [ Designated as safety issue: Yes ]
Hospital/ER for toxic epidermal necrolysis (TEN) [ Time Frame: 12-months, 18-months, 36-months, and 54-months ] [ Designated as safety issue: Yes ]
Hospital/ER for other severe skin reactions [ Time Frame: 12-months, 18-months, 36-months, and 54-months ] [ Designated as safety issue: Yes ]
Hospitalized for all endpoints [ Time Frame: 12-months, 18-months, 36-months, and 54-months ] [ Designated as safety issue: Yes ]
Hospitalized/ER visits for hypersensitivity reactions [ Time Frame: 12-months, 18-months, 36-months, and 54-months ] [ Designated as safety issue: Yes ]
Death from hypersensitivity reactions [ Time Frame: 12-months, 18-months, 36-months, and 54-months ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Patients exposed to saxagliptin
Patients exposed to oral antidiabetic drugs (not saxagliptin)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

113505

Estimated Completion Date

April 2015

Estimated Primary Completion Date

April 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01086319

Other Study ID Numbers ^ICMJE

CV181-103

Has Data Monitoring Committee

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

AstraZeneca
University of Pennsylvania

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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