Risk of Acute Kidney Injury Among Patients With Type 2 Diabetes Exposed to Oral Antidiabetic Treatments
NCT ID: NCT01377935
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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This will be a prospectively-designed database cohort study comparing hospitalizations for acute kidney injury among new initiators of Saxagliptin compared to those who are new initiators of OADs in classes other than DPP4 inhibitors. The study time frame will be from 2009 through 2014.
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 OAD in classes other than DPP4 inhibitors
OAD - Oral Antidiabetic Drug
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Newly prescribed Saxagliptin or an OAD in a class other than DPP4 inhibitors
* Enrolled in the respective database for at least 180 days prior to the first prescription of new OAD
Exclusion Criteria
* Patients with DPP4 inhibitor exposure during the baseline period
* Patients currently using Exenatide or Insulin
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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BMS Clinical Trials Disclosure
Investigator Inquiry form
For FDA Safety Alerts and Recalls refer to the following link
Other Identifiers
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CV181-157
Identifier Type: -
Identifier Source: org_study_id
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