A Study Based on Data From German Registries That Looks at Characteristics of People Who Take the Medicine Empagliflozin for Type 2 Diabetes

Study Overview
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Brief Summary
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Description of the real-life treatment of adult patients with type-2 diabetes mellitus (T2DM) receiving Empagliflozin, comparing the characteristics of patients starting Empagliflozin in three time intervals

Official Title
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Treatment of T2DM Patients in Germany Receiving Empagliflozin: A Retrospective RWE Study Description of Treatment and Population Characteristics of Type 2 Diabetic Patients in Germany Receiving Empagliflozin: A Retrospective Real-World Evidence (RWE) Study Based on German Registries DPV&DIVE

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Empagliflozin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least two outpatient T2DM diagnoses (ICD E11.-) in two different quarters and/or at least one inpatient T2DM diagnosis (ICD E11) At least one prescription of an empagliflozin-containing antidiabetic drug: Jardiance® (Empagliflozin, ATC A10BK03, former A10BX12) or Synjardy® (Empagliflozin/ Met¬for¬min, ATC A10BD20) Exclusion Criteria: Any diagnosis of T1DM

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 receiving Empagliflozin until mid Sep 2015<br>Patients receiving Empagliflozin before the EMPA-REG-OUTCOME study was published time until mid-Sept. 2015; Cohort 1 | Drug: Empagliflozin<br>* drug<br>|
| Patients receiving Empagliflozin until CV Label Change time<br>Patients receiving Empagliflozin starting from the EMPA-REG-OUTCOME study being published until CV Label Change time from mid-Sept. 2015-mid-Jan. 2017; Cohort 2 | Drug: Empagliflozin<br>* drug<br>|
| Patients receiving Empagliflozin until last available data cut<br>Patients receiving Empagliflozin starting from mid-Jan. 2017 until last; Cohort 3 | Drug: Empagliflozin<br>* drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities | Percentage of patients with previous occurence of cardiovascular (CV) comorbidities, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, congestive heart failure. | At baseline. | 
| Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications | Percentage of participants with previous occurence of other typical diabetes complications, including, Neuropathy, Nephropathy, Chronic Kidney Disease, Microalbuminuria, Macroalbuminuria, estimated glomerular filtration rate (eGFR), diabetic foot syndrome, retinopathy (background and proliferative). | At baseline. | 
| Percentage of Participants With Antidiabetic and Cardiovascular Co-medication | Percentage of participants with antidiabetic and cardiovascular co-medication, including lipid-lowering agents, other antihypertensives, antiplatelets and anticoagulants. | At baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants by Age Category | Percentage of participants by age category; younger than 65 (< 65), from 65 to 74 (65 ≤ 75) , from 75 to 80 (75 - 80) , older than 80 (> 80). | At baseline. | 
| Percentage of Male Participants | The percentage of male participants is reported. | At baseline. | 
| Weight of Participants | Weight of participants. | At baseline. | 
| Height of Participants | Height of participants. | At baseline. | 
| Glycated Hemoglobin (HbA1c) | Glycated hemoglobin (HbA1c). | At baseline. | 
| Duration of Diabetes | Duration of diabetes (time since diagnosis). | At baseline. | 
| Percentage of Participants With Previous Glucose-lowering Treatment | Percentage of participants with glucose-lowering treatment prior to empagliflozin initiation. | At baseline. | 
| Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes | Percentage of patients participated in Disease Management Programme (DMP) Type 2 Diabetes. | At baseline. | 
| Number of Participants With Hospitalizations | Number of participants with hospitalizations. | At baseline. | 
| Dosage of Empagliflozin | Dosage of empagliflozin. Number of patients on 10 milligram versus patients on 25 milligram empagliflozin. | At baseline. | 
| Fasting Plasma Glucose (FPG) | Fasting plasma glucose (FPG). | At baseline. |