Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Phase phase 4
Sponsor Janssen Research & Development, LLC
Start date February 2016
End date December 2018
Trial size 100000 participants
Trial identifier NCT02857764, RRA-17578

Summary

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
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.
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.
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.
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.
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.

Primary Outcomes

Measure
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
time frame: 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
time frame: up to 6 years (estimated study duration)
Incidence of Below-Knee Lower Extremity Amputation in Canagliflozin New Users Versus non-SGLT2i Aha New Users
time frame: up to 6 years (estimated study duration)

Eligibility Criteria

Male or female participants at least 18 years old.

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,
    • 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.

Additional Information

Official title SGLT2 Inhibitor Risk of Below-Knee Lower Extremity Amputation: A Retrospective Cohort Study Using a Large Claims Database in the United States
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Janssen Research & Development, LLC.