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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medicinal product name:
  JARDIANCE

  SYNJARDY
• Study drug International non-proprietary name (INN) or common name:
  EMPAGLIFLOZIN

Population studied

• Short description of the study population:
  Type 2 Diabetic Patients in Germany receiving Empagliflozin
• Estimated number of subjects:
  7.900

Study design details

• Study design:
  Retrospective non-interventional cross-sectional study
• Main study objective:
  Description of the real-life treatment of adult patients with T2DM receiving empagliflozin, comparing the characteristics of patients starting empagliflozin in three time intervals:; - The first analysis will include the patients receiving Empagliflozin before the EMPA-REG-OUTCOME study was published (time until mid-Sept. 2015; “Cohort 1”).; - The second analysis will include 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”). ; - The third analysis will include all patients receiving Empagliflozin starting from mid-Jan. 2017 until last available data cut (“Cohort 3").
• Setting:
  Real-world data from German patient registries
• Outcomes:
  Primary outcomes;  Previous occurrence (percentages) of; o Typical CV comorbidities:;  MI;  Stroke;  CAD;  PAD;  CHF (form (HFrEF/ HFpEF); o Other typical diabetes complications:;  Neuropathy;  Nephropathy / Renal function (eGFR, micro-/ macroalbuminuria);  Diabetic foot syndrome;  Retinopathy (background and proliferative);  Antidiabetic and cardiovascular co-medication (lipid-lowering agents, RAAS blockers, other antihypertensives, beta blockers, diuretics, antiplatelets and anticoagulants ); ; Secondary outcomes;  Age(<65; 65 – <75; 75 – 80 , >80);  Gender;  Weight [kg];  Height [cm];  HbA1c [% or mmol/ mol], FPG (available in subgroup only);  Duration of diabetes (time since diagnosis);  Previous glucose-lowering treatment;  Dosage of empagliflozin (10mg vs 25mg) (available in subgroup only);  Participation in Disease Management Programme (DMP) Type 2 Diabetes (from DPV registry);  Hospitalizations (from DPV registry)
• Data analysis plan:
  Variables will be assessed in half-yearly periods after index date (date of first prescription of empagliflozin), for total study population and separated by study cohort.; Anonymized data from the DIVE and the DPV registries will be combined; nonparametric descriptive analyses will be used. Group comparison will be based on Wilcoxon rank sum test (continuous variables) and X²-test for binary/categorial values. Analysis will be implemented using SAS 9.4. Complete case analysis will be used.; Analysis will be done by an experienced biostatistician with detailed knowledge of the DIVE and the DPV registries. A second independent programmer will check the generated SAS code for inconsistencies. The medical team will evaluate the results from a clinical background to ensure plausibility. Quality assurance and control will be the responsibility of the medical team.