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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Study type: Observational

Funder types: Industry

Identifiers

NCT02857764

RRA-17578 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to estimate the incidence of below-knee lower extremity amputation in type 2 diabetes mellitus (T2DM) participants newly exposed to sodium-glucose co-transporter 2 inhibitors (SGLT2i)/ non-SGLT2i antihyperglycemic agents (AHA) overall and in the subgroup with high cardiovascular (CV) risk and to compare the hazards of below-knee lower extremity amputation in canagliflozin new users versus non-SGLT2i AHA new users.

Enrollment: 127,690 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• First exposure to the particular drug in person's history
• 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

• Participants who had amputations prior to the index date were excluded.

Trial design

127,690 participants in 5 patient groups

Sodium-glucose Co-transporter 2 Inhibitors (SGLT2i) New Users

Description:

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.

Canagliflozin New Users

Description:

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.

Dapagliflozin New Users

Description:

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.

Empagliflozin New Users

Description:

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.

First-time Non-SGLT2i AHA New Users

Description:

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.