Study identification

PURI

https://redirect.ema.europa.eu/resource/36466

EU PAS number

EUPAS28505

Study ID

36466

Official title and acronym

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

DARWIN EU® study

No

Study countries

Bulgaria
Czechia
Hungary
Poland
Russian Federation
Serbia
Slovenia

Study description

This study is initiated 1. 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 2. To describe the burden of comorbidities (prevalence of CVD, CKD) and CVD/CKD risk factors in this T2D patient population at index date 1 3. To describe and compare the actual treatment at study index date 1 in patients with and without established CVD Established CV disease defined as acute myocardial infarction (AMI), cardiology intervention, ischemic heart disease (IHD), congestive heart failure (CHF), peripheral arterial disease (PAD), or stroke. 4. To describe the association of socioeconomic parameters with treatment decisions at index date 1 5. To assess the discontinuation rate, reasons for discontinuation and average duration of treatment for GLP1a, DPP4i and SGLT2i after a follow up of approximately one year from the initial time point (= index date 2)

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 260 centres are involved in the study

Contact details

Martin Prázný

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim RCV GmbH & Co KG
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable