CORDIALLY® - CEE: Characteristics of patients with Type 2 Diabetes treated with modern antidiabetic drugs. A real world data collection of patient baseline characteristics, treatment patterns and comorbidities in Central Eastern European (CEE) countries

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Study of association of socioeconomic parameters with treatment decision
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Multi-country, multi-site study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10BK) Sodium-glucose co-transporter 2 (SGLT2) inhibitors

  Sodium-glucose co-transporter 2 (SGLT2) inhibitors

  (A10BH) Dipeptidyl peptidase 4 (DPP-4) inhibitors

  Dipeptidyl peptidase 4 (DPP-4) inhibitors

  (A10BJ) Glucagon-like peptide-1 (GLP-1) analogues

  Glucagon-like peptide-1 (GLP-1) analogues
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  The study population included patients aged 18 years or older diagnosed with type 2 diabetes mellitus (T2DM) initiated treatment with empagliflozin or other SGLT2i, DPP4i or GLP-1 RA between August 2019 and January 2021 in European countries.; Inclusion criteria:; 1. Written informed consent prior to participation; 2. Female and male patients age ≥18 years; 3. Patients with T2D diagnosis; 4. Patients who have been initiated (first ever use) with empagliflozin or other SGLT2i, DPP4i or GLP-1 RA between September 2018 and December 2018 (study index date 1); 5. Patients who have been naive to treatment with empagliflozin or other SGLT2i, DPP4i or GLP-1 RA at study index date 1; ; Exclusion criteria:; 1. Patients age <18 years; 2. Patients diagnosis of other types of diabetes than T2D; 3. Patients who do not provide written consent to the terms of the study.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with type 2 diabetes mellitus
• Estimated number of subjects:
  4000

Study design details

• Main study objective:
  To describe and compare T2D patients' baseline characteristics when initiating either empagliflozin - or other SGLT2i, DPP4i or GLP1a on top of current antidiabetic treatment by different HCP specialties in CEE countries
• Outcomes:
  T2D patients’ baseline characteristics when initiating either empagliflozin - or other SGLT2i, DPP4i or GLP1a on top of current antidiabetic treatment by different HCP specialties in CEE countries., Burden of comorbidities (prevalence of CVD, CKD and CVD/CKD risk factors) (index date 1) - Actual treatment use (index date 1) in patients with/without established CVD - Association of socioeconomic parameters with treatment decisions (index date 1) - Discontinuation rate of actual treatment (index date 2), reasons for discontinuation and average treatment duration for GLP1a, DPP4i and SGLT2
• Data analysis plan:
  All analyses in this study are descriptive; results are to be interpreted in an explorative manner. For categorical variables summary tabulations of the number and percentage within each category (with a category for missing data) of the parameter will be presented. For continuous variables number of values, mean, standard deviation, minimum, median, maximum and number of missing values will be presented. Incidence rates and 95% CI will be given when appropriate.

Documents

Study results

1245-0187-CORDIALLY_CSR_final V1.0_Abstract