Study S002479

SGLT2 Inhibitor Risk of Below-Knee Lower Extremity Amputation: A Retrospective Cohort Study Using a Large Claims Database in the United States

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT02857764
Study type: OBSERVATIONAL
Status: COMPLETED
Enrollment: 127690
Start: 2016-02-15
Primary completion: 2017-06-30
Lead sponsor: Janssen Research & Development, LLC
Conditions: Diabetes Mellitus, Type 2
Results posted: FALSE
Secondary identifiers: OTHER:RRA-17578

Registered primary outcomes

Incidence of Below-knee Lower Extremity Amputation in Type 2 Diabetes Mellitus (T2DM) Patients Newly Exposed to Sodium-glucose Co-transporter 2 Inhibitors (SGLT2i) Overall and in the Subgroup With High Cardiovascular (CV) Risk [up to 6 years (estimated study duration)]
Incidence of Below-Knee Lower Extremity Amputation in T2DM Patients Newly Exposed To non-SGLT2i Aha Overall And In The Subgroup With High CV Risk [up to 6 years (estimated study duration)]
Incidence of Below-Knee Lower Extremity Amputation in Canagliflozin New Users Versus non-SGLT2i Aha New Users [up to 6 years (estimated study duration)]

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