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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

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ClinicalTrials.gov Identifier: NCT02857764
Recruitment Status : Completed
First Posted : August 5, 2016
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Diabetes Mellitus, Type 2

Study Type : Observational
Actual Enrollment : 127690 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: SGLT2 Inhibitor Risk of Below-Knee Lower Extremity Amputation: A Retrospective Cohort Study Using a Large Claims Database in the United States
Actual Study Start Date : February 15, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Group/Cohort
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.
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.
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.
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.
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.



Primary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. 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) ]
    Hazard ratio will be estimated using a conditional Cox proportional hazards model based on propensity-matched cohorts.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who are new users (with at least 365 day of prior observation) to a drug exposure of interest between April 1, 2013 and January 31, 2015 and at least 1 condition occurrence of 'Type II diabetes' any time before or on index and no condition occurrences of 'Type I diabetes' or 'Secondary diabetes' any time before or on index date. January 31, 2015 reflects the data cutoff date for the initial analysis.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02857764


Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02857764     History of Changes
Other Study ID Numbers: RRA-17578
RRA-17578 ( Other Identifier: Janssen Research & Development, LLC. )
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Empagliflozin
Canagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs