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

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT02857764
• Lead Sponsor: Janssen Research & Development, LLC

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2016-02-15
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-03
• Study First Posted: 2016-08-05
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127690

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	The occurrence of a below-knee lower extremity amputation will be defined by observing an associated procedure code in the outpatient or inpatient medical service claims.
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)	The occurrence of a below-knee lower extremity amputation will be defined by observing an associated procedure code in the outpatient or inpatient medical service claims.
Incidence of Below-Knee Lower Extremity Amputation in Canagliflozin New Users Versus non-SGLT2i Aha New Users	up to 6 years (estimated study duration)	Hazard ratio will be estimated using a conditional Cox proportional hazards model based on propensity-matched cohorts.