Risk of Hospitalization for Severe Hypersensitivity (Including Severe Skin Reactions) in Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments
NCT ID: NCT01086319
Last Updated: 2016-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
113505 participants
OBSERVATIONAL
2009-08-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
Study Groups
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Patients exposed to saxagliptin
No interventions assigned to this group
Patients exposed to oral antidiabetic drugs (not saxagliptin)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 prescribed a DPP4 inhibitor during the baseline period
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
University of Pennsylvania
OTHER
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
References
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Lo Re V, Carbonari DM, Saine ME, Newcomb CW, Roy JA, Liu Q, Wu Q, Cardillo S, Haynes K, Kimmel SE, Reese PP, Margolis DJ, Apter AJ, Reddy KR, Hennessy S, Bhullar H, Gallagher AM, Esposito DB, Strom BL. Postauthorization safety study of the DPP-4 inhibitor saxagliptin: a large-scale multinational family of cohort studies of five outcomes. BMJ Open Diabetes Res Care. 2017 Jul 31;5(1):e000400. doi: 10.1136/bmjdrc-2017-000400. eCollection 2017.
Saine ME, Carbonari DM, Newcomb CW, Nezamzadeh MS, Haynes K, Roy JA, Cardillo S, Hennessy S, Holick CN, Esposito DB, Gallagher AM, Bhullar H, Strom BL, Lo Re V 3rd. Determinants of saxagliptin use among patients with type 2 diabetes mellitus treated with oral anti-diabetic drugs. BMC Pharmacol Toxicol. 2015 Apr 2;16:8. doi: 10.1186/s40360-015-0007-z.
Related Links
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Other Identifiers
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CV181-103
Identifier Type: -
Identifier Source: org_study_id
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