Sodium-glucose Co-transporter 2 (SGLT2) Inhibitor Risk of Below-Knee Lower Extremity Amputation: A Retrospective Cohort Study Using a Large Claims Database in the United States
NCT ID: NCT02857764
Last Updated: 2017-08-30
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
127690 participants
OBSERVATIONAL
2016-02-15
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Sodium-glucose Co-transporter 2 Inhibitors (SGLT2i) New Users
Participants will not receive any intervention as a part of this study. SGLT2i includes canagliflozin, dapagliflozin, empagliflozin as prescribed in clinical practice. Participants will be evaluated in 2 sub-cohorts (with or without high CV risk) and overall.
No interventions assigned to this group
Canagliflozin New Users
Participants will not receive any intervention as a part of this study. This cohort contains new users of canagliflozin as prescribed in clinical practice. Participants will be evaluated in 2 risk) and overall.
No interventions assigned to this group
Dapagliflozin New Users
Participants will not receive any intervention as a part of this study. This cohort contains new users of dapagliflozin as prescribed in clinical practice. Participants will be evaluated in 2 sub-cohorts (with or without high CV risk) and overall.
No interventions assigned to this group
Empagliflozin New Users
Participants will not receive any intervention as a part of this study. This cohort contains new users of empagliflozin as prescribed in clinical practice. Participants will be evaluated in 2 sub-cohorts (with or without high CV risk) and overall.
No interventions assigned to this group
First-time Non-SGLT2i AHA New Users
Participants will not receive any intervention as a part of this study. Non-SGLT2i AHA include dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) agonists, thiazolidinediones (TZDs), Sulfonylureas, Insulin, and other AHAs. Participants will be evaluated in 2 sub-cohorts (with or without high CV risk) and overall.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* For the initial analysis, exposure start is between April 1, 2013 and January 31, 2015. For the ongoing repeat analysis per the protocol amendment, the study period ending date will vary depending on the time of each data extraction and analysis
* At least 365 days of observation time prior to index
* At least 1 condition occurrence of 'Type II diabetes' any time before or on index
* Exactly 0 condition occurrences of 'Type I diabetes' any time before or on index
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Other Identifiers
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RRA-17578
Identifier Type: OTHER
Identifier Source: secondary_id
RRA-17578
Identifier Type: -
Identifier Source: org_study_id
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