A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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Non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of Type 2 diabetes mellitus.

Official Title
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Multi-country Non-interventional Study on the Effectiveness of Empagliflozin in Adult Patients With Type 2 Diabetes in Europe and Asia.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor
* Drug: Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dispensation or any other record of empagliflozin, any SGLT-2 inhibitor, or any DPP-4 inhibitor use during the study period No dispensation or any other record of any other SGLT-2 inhibitor or DPP-4 inhibitor use during the preceding 12 months including at index date Having a diagnosis of T2DM before the index date, based on ICD-10 codes or other available data Exclusion Criteria: Aged <18 years on the first dispensation date or date of the first record of empagliflozin, any SGLT-2 inhibitor or any DPP-4 inhibitor use Type 1 diabetes mellitus Secondary diabetes Gestational diabetes Having a diagnosis of ESRD during the 12 months before the index date <12 months of available data before the index date, and/or no complete history of drug dispensations/other records of the drug use during this period Missing or ambiguous data on age or sex

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with T2DM<br> | Drug: Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor<br>* Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor<br>Drug: Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor<br>* Dipeptidyl peptidase-4 (DPP-4) inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants hospitalized for heart failure |  | up to 4.5 years | 
| Number of participants with all-cause mortality |  | up to 4.5 years | 
| Number of participants with both hospitalization for heart failure and all cause mortality |  | up to 4.5 years | 
| Number of participants with myocardial infraction (MI), stroke, all cause mortality |  | up to 4.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Cardiovascular mortality |  | up to 4.5 years | 
| Number of participants with a composite outcome including hospitalization for heart failure and cardiovascular (CV) mortality |  | up to 4.5 years | 
| Number of participants with 3-point major adverse cardiovascular (CV) events (MACE), defined as a composite outcome including myocardial infarction (MI),stroke, and cardiovascular (CV) mortality |  | up to 4.5 years | 
| Number of participants with coronary revascularization procedure |  | up to 4.5 years | 
| Number of participants with end-stage renal disease (ESRD) |  | up to 4.5 years | 
| Number of participants with estimated glomerular filtration rate (eGFR) decline |  | up to 4.5 years | 
| Number of participants with progression from normoalbuminuria to micro- or macroalbuminuria |  | up to 4.5 years | 
| Number of participants with a composite outcome including eGFR decline and progression to micro- or macroalbuminuria |  | up to 4.5 years | 
| Number of participants with bone fracture |  | up to 4.5 years | 
| Number of participants with diabetic ketoacidosis |  | up to 4.5 years | 
| Number of participants with severe hypoglycemia |  | up to 4.5 years | 
| Number of participants with lower-limb amputation |  | up to 4.5 years | 
| Number of participants with acute kidney injury requiring dialysis |  | up to 4.5 years | 
| Healthcare resource utilization |  | up to 4.5 years | 
| Cost of care | Costs of HCRU | up to 4.5 years |