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| ID | Type | Description | Link |
|---|---|---|---|
| RRA-17578 | Other Identifier | Janssen Research & Development, LLC. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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 | 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. | up to 6 years (estimated study duration) |
| Incidence of Below-Knee Lower Extremity Amputation in Canagliflozin New Users Versus non-SGLT2i Aha New Users | Hazard ratio will be estimated using a conditional Cox proportional hazards model based on propensity-matched cohorts. | up to 6 years (estimated study duration) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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