DIA_CENTRAL:T2D Treatment Pattern in Central Europe

NCT ID: NCT03807440

Last Updated: 2023-12-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4083 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-26
• Study Completion Date: 2021-08-31

Brief Summary

This is a non-interventional study using existing data including medical chart review.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Subjects with Diabetes Mellitus, Type 2

Empagliflozin

Intervention Type: DRUG

Empagliflozin

Sodium Glucose Transporter 2 inhibitor

Intervention Type: DRUG

Sodium Glucose Transporter 2 inhibitor

Dipeptidyl-peptidase 4 inhibitor

Intervention Type: DRUG

Dipeptidyl-peptidase 4 inhibitor

Glucagon-like peptide 1 agonist

Intervention Type: DRUG

Glucagon-like peptide 1 agonist

Interventions

Empagliflozin

Empagliflozin

Intervention Type: DRUG

Sodium Glucose Transporter 2 inhibitor

Sodium Glucose Transporter 2 inhibitor

Intervention Type: DRUG

Dipeptidyl-peptidase 4 inhibitor

Dipeptidyl-peptidase 4 inhibitor

Intervention Type: DRUG

Glucagon-like peptide 1 agonist

Glucagon-like peptide 1 agonist

Intervention Type: DRUG

Other Intervention Names

Jardiance® Synjardy® Trajenta® Jentadueto®; Jardiance® Synjardy® Trajenta® Jentadueto®; Jardiance® Synjardy® Trajenta® Jentadueto®; Jardiance® Synjardy® Trajenta® Jentadueto®

Eligibility Criteria

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 newly initiated (first ever use) with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), Dipeptidyl-peptidase 4 inhibitor (DPP4i) or Glucagon-like peptide 1 agonist (GLP1a) between September 2018 and December 2018 (study index date 1)

5. Patients have been naïve to treatment with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), Dipeptidyl-peptidase 4 inhibitor (DPP4i) or Glucagon-like peptide 1 agonist (GLP1a) at study index date 1

Exclusion Criteria

1. Patients age < 18 years

2. Patients with diagnosis of other types of diabetes than T2D

3. Patients who do not provide written consent to the terms of the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexey Medvedchikov, +43180105-7896

Role: STUDY_CHAIR

Alexey.Medvedchikov@Boehringer-Ingelheim.com

Locations

MHAT "Julia Verevska-Byala" EOOD, Center Nr.: 35903

Byala, , Bulgaria

MC "Diamedical 2013" OOD, Center Nr.: 35902

Dimitrovgrad, , Bulgaria

MBAL- Dobrich AD, Center Nr.: 35916

Dobrich, , Bulgaria

Dr. T. K. Bacheva - ASMP-IP-E EOOD, Center Nr.: 35904

Dupnitsa, , Bulgaria

MHAT "Medline Clinic", Center Nr.: 35911

Plovdiv, , Bulgaria

MC Kuchuk Parij OOD, Center Nr.: 35906

Plovdiv, , Bulgaria

MC Saint Elisaveta-Rakovski EOOD, Center Nr.: 35909

Rakovski, , Bulgaria

"Medical Center-Razgrad"OOD, Center Nr.: 35910

Razgrad, , Bulgaria

DCC 1 - Russe EOOD, Center Nr.: 35905

Rousse, , Bulgaria

MBAL "Hadzhi Dimitar" OOD, Center Nr.: 35915

Sliven, , Bulgaria

MC Polimed AD, Center Nr.: 35907

Sofia, , Bulgaria

MC Gina - LZ SIMP EOOD, Center Nr.: 35918

Sofia, , Bulgaria

MC "Vitaclinic" EOOD, Center Nr.: 35901

Sofia, , Bulgaria

MC Kalimat EOOD, Center Nr.: 35914

Sofia, , Bulgaria

Acibadem City Clinic Medical Center Varna EOOD, Center Nr.: 35908

Varna, , Bulgaria

Michal Brada, Center Nr.: 42001

Beclav, , Czechia

Dr. Kovaová, Center Nr.: 42069

Beroun, , Czechia

Practice Dr. Alice Sýkorová, Center Nr.: 42057

Bílina, , Czechia

MUDr. Alica Vesela, Center Nr.: 42030

Broumov, , Czechia

EUC Klinika eské Budjovice, Center Nr.: 42052

Eské Budjovice, , Czechia

Lékaský dm Géko, Center Nr.: 42059

Eské Budjovice, , Czechia

Barbara Buzová, Center Nr.: 42003

Havíov, , Czechia

Zaviatiová, Petra, Center Nr.: 42004

Havíov, , Czechia

Radana Syslová, Center Nr.: 42035

Hlušovice, , Czechia

Pavel Kasík, Center Nr.: 42046

Hoovice, , Czechia

Practice Dr. Petr Maule, Center Nr.: 42054

Humpolec, , Czechia

Mediab Jihlava s.r.o., Center Nr.: 42066

Jihlava, , Czechia

Practice MUDr. Gita Markofová, Center Nr.: 42053

Karlovy Vary, , Czechia

Dr. Konená, Center Nr.: 42036

Karviná - Staré Msto, , Czechia

Practice Zdzislaw Wranka, Center Nr.: 42072

Karviná-Hranice, , Czechia

Pavel Tománek, Center Nr.: 42028

Kopivnice, , Czechia

DIABET HELP s.r.o., Center Nr.: 42058

Kralupy nad Vltavou, , Czechia

MUDr.Tomáš Edelsberger, Center Nr.: 42007

Krnov, , Czechia

Jitka Hasalová, Center Nr.: 42010

Kromiz, , Czechia

árka Drinková, Center Nr.: 42038

Lede Nad Sázavou, , Czechia

Martina Košková, Center Nr.: 42047

Mladá Boleslav, , Czechia

Dobromila Vykoupilová, Center Nr.: 42033

Nmice Nad Hanou, , Czechia

Karel Churavý, Center Nr.: 42005

Nový Jiín, , Czechia

árka Kubánková, Center Nr.: 42048

Nymburk, , Czechia

Agentura Science Pro spol. s.r.o., Center Nr.: 42002

Olomouc, , Czechia

Anna Rancová, Center Nr.: 42025

Olomouc, , Czechia

Josef íný, Center Nr.: 42026

Opava, , Czechia

MUDr.Tomáš Hrdina, Center Nr.: 42015

Opono, , Czechia

Dr. Šeptáková, Center Nr.: 42074

Ostrava, , Czechia

Practice Dr. René Turínek, Center Nr.: 42034

Ostrava, , Czechia

MUDr. Eva Raická, Center Nr.: 42024

Ostrava, , Czechia

Jitka Homolová, Center Nr.: 42012

Ostrava, , Czechia

Radka Nágelová, Center Nr.: 42020

Ostrava Poruba, , Czechia

AIDIN VK s.r.o., Center Nr.: 42017

Perov, , Czechia

MUDr. Vra Prýmková, Center Nr.: 42070

Píbram, , Czechia

Zdenk Jankovec, Center Nr.: 42044

Plze, , Czechia

Diabetologická a interní ambulance, Center Nr.: 42064

Podbrady, , Czechia

MUDr. Jana Houdová, Center Nr.: 42068

Prague, , Czechia

Practice Dr. Milena Peterková, Center Nr.: 42063

Prague, , Czechia

MUDr.Michala Pelikánová s.r.o., Center Nr.: 42055

Prague, , Czechia

Markéta Hovorková, Center Nr.: 42042

Prague, , Czechia

Jakub Hron, Center Nr.: 42043

Prague, , Czechia

Milan Fleka, Center Nr.: 42041

Prague, , Czechia

Jií Jón, Center Nr.: 42045

Prague, , Czechia

Practice Dr. Lucie Kufová, Center Nr.: 42062

Prague, , Czechia

Practice Dr. Ida Reissová, Center Nr.: 42056

Prague, , Czechia

Barbora Diepoltová, Center Nr.: 42037

Prague, , Czechia

Practice Dr. Petronela Janeková, Center Nr.: 42065

Rumburk, , Czechia

Practice Dr. Miroslav Lindovský, Center Nr.: 42051

Sokolov, , Czechia

Dana Fialkoviová, Center Nr.: 42040

Strakonice, , Czechia

Marek Frydrych, Center Nr.: 42008

Tebí, , Czechia

Marek Frydrych, Center Nr.: 42077

Tebí, , Czechia

Diabetologická ambulance s.r.o., Center Nr.: 42076

Uherské Hradišt, , Czechia

Dr. Hrmová, Center Nr.: 42073

Vlašim, , Czechia

Lubomír Kudlej, Center Nr.: 42050

Vrchlabí, , Czechia

AdiaMed s.r.o., Center Nr.: 42009

Vsetín, , Czechia

EUC Klinika Zlín a.s., Center Nr.: 42075

Zlín, , Czechia

Robin Urbánek, Center Nr.: 42029

Zlín, , Czechia

Bajcsy-Zsilinszky Kórház és Rendelintézet, Center Nr.: 36019

Budapest, , Hungary

Jahn Ferenc Dél-pesti Kórház és Rendelintézet, Center Nr.: 36014

Budapest, , Hungary

Debreceni Egyetem Klinikai Központ, Kardiológiai Klinika, Center Nr.: 36006

Debrecen, , Hungary

Kátai Gábor Kórház, Diabetológia Szakrendelés, Center Nr.: 36007

Karcag, , Hungary

Practice Dr. Lelkesi Anita, Center Nr.: 36013

Mátészalka, , Hungary

Nagyatádi Kórház, Center Nr.: 36021

Nagyatád, , Hungary

Nyírségi Diabetes Centrum, Center Nr.: 36024

Nyíregyháza, , Hungary

Dr. Wagner Zoltán, Center Nr.: 36020

Pécs, , Hungary

Siófoki Kórház Rendelintézet, Center Nr.: 36004

Siófok, , Hungary

Soproni Gyógyközpont, Center Nr.: 36018

Sopron, , Hungary

Gabinet Diabetologiczno- Internistyczny Katarzyna Wasilewska, Center Nr.: 48011

Biaystok, , Poland

NZOZ DIAMED Sp. z o.o., Center Nr.: 48061

Czechowice-Dziedzice, , Poland

Prywatny Gabinet Lekarski dr n. med. Joanna Sawer-Szewczyk, Center Nr.: 48055

Czyca, , Poland

Zespó Opieki Zdrowotnej w czycy, Center Nr.: 48054

Czyca, , Poland

NZOZ Sal Med, Center Nr.: 48047

Dzieroniów, , Poland

Poradnia Diabetologiczna, Center Nr.: 48028

Gorlice, , Poland

Indywidualna Specjalistyczna Praktyka Lekarska Piotr Piskozub Specjalista Diabetolog, Center Nr.: 48042

Jelenia Góra, , Poland

NZOZ Poradnia Diabetologiczna, Center Nr.: 48038

Konin, , Poland

Zakad Opieki Medycznej Sanatio; Sp. Z. o.o., Center Nr.: 48030

Krakow, , Poland

Prywatny Gabinet Lekarski Tomasz Wierzykowski, Center Nr.: 48053

Kutno, , Poland

Indywidualna Specjalistyczna Praktyka Lekarska Magorzata Poskoska-Lemaska, Center Nr.: 48035

Kwidzyn, , Poland

Indywidualna Specjalistyczna Praktyka Lekarska Barbara Soróbka, Center Nr.: 48001

Legnica, , Poland

Poradnia Cukrzycowa SP ZOZ w Lesku, Center Nr.: 48024

Lesko, , Poland

Lumed Sp. z o.o., Center Nr.: 48032

Lubaczów, , Poland

DIABETA-CARE Sp.z o.o., Center Nr.: 48008

Lubin, , Poland

Poradnia Diabetologiczna Dr. mudziska, Center Nr.: 48013

Nako Nad Noteci, , Poland

Alfa Specjalistyczne Gabinety Lekarskie Ewa Moroz, Center Nr.: 48007

Nowy Scz, , Poland

Poradnia Diabetologiczna Dr. Adamczyk-Gajda, Center Nr.: 48031

Olenica, , Poland

MED-ART Sp. z o.o., Center Nr.: 48052

Orzesze, , Poland

Indywidualna Specjalistyczna Praktyka Lekarska Wiesawa Fischer, Center Nr.: 48020

Ostrów Wielkopolski, , Poland

Prywatny Gabinet Lekarski azuka, Center Nr.: 48026

Parczew, , Poland

Powiatowy Szpital Specjalistyczny w Stalowej Woli, Center Nr.: 48056

Stalowa Wola, , Poland

Prywatny Gabinet Lekarski dr n. med. Piotr Gryglas, Center Nr.: 48059

Warsaw, , Poland

Poradnia Diabetologiczna Szpitala Powiatowego w Wicborku, Center Nr.: 48003

Wicbork, , Poland

Orodek Praktyka Lekarska Konrad Strzelczyk, Center Nr.: 48012

Woomin, , Poland

Poradnia Diabetologiczna SPZZOZ w Wyszkowie, Center Nr.: 48067

Wyszków, , Poland

Wojewódzka Poradnia dla Chorych na Cukrzyc, Center Nr.: 48025

Zabrze, , Poland

Cardiomed, Center Nr.: 48019

Zielona Góra, , Poland

Anturium, Center Nr.: 70036

Barnaul, , Russia

Central city hospital, Center Nr.: 70073

Bataysk, , Russia

Chelyabinsk regional clinical hospital, Center Nr.: 70069

Chelyabinsk, , Russia

Russian Medical Academy of Continuing Professional Education, Center Nr.: 70058

Irkutsk, , Russia

The First Republican Clinical Hospital of the Ministry of Health of the Udmurt Republic, Center Nr.: 70037

Izhevsk, , Russia

Central City Hospital No. 18, Center Nr.: 70051

Kazan', , Russia

Kemerovo regional clinical hospital named S.V. Belyaev, Center Nr.: 70008

Kemerovo, , Russia

City Polyclinic No. 16, Center Nr.: 70067

Khabarovsk, , Russia

Kirov Clinical Hospital No. 7 named after V.I. Yurlova, Center Nr.: 70089

Kirov, , Russia

Krai clinical hospital Nr. 1 named after prof. S.V. Ochapovskogo, Center Nr.: 70049

Krasnodar, , Russia

Lipetsk Regional Hospital, Center Nr.: 70046

Lipetsk, , Russia

SBIH Center for Speech Pathology and Neurorehabilitation MDH, Center Nr.: 70080

Moscow, , Russia

Clinical Hospital No. 85 of trhe Federal Biomedical Agency, Center Nr.: 70042

Moscow, , Russia

National Medical Research Center for Endocrinology, Center Nr.: 70025

Moscow, , Russia

City Polyclinic No. 22 of the Department of Healthcare of the Moscow City, Center Nr.: 70043

Moscow, , Russia

City Polyclinic No. 22 of the Department of Healthcare of the Moscow City, Center Nr.: 70045

Moscow, , Russia

Endocrinology Dispensary of the Moscow City Healthcare Department, Center Nr.: 70032

Moscow, , Russia

Endocrinology Dispensary of the Moscow City Healthcare Department, Center Nr.: 70041

Moscow, , Russia

Endocrinology Dispensary of the Moscow City Healthcare Department, Center Nr.: 70081

Moscow, , Russia

Endocrinology Dispensary of the Moscow City Healthcare Department, Center Nr.: 70084

Moscow, , Russia

Vessel Clinic, Center Nr.: 70011

Moscow, , Russia

City Polyclinic No 107 of the Moscow City Healthcare Department, Center Nr.: 70082

Moscow, , Russia

City Clinical Hospital named after V.V. Veresaeva of the Moscow Department of Health, Center Nr.: 70003

Moscow, , Russia

City Polyclinic No. 1, Center Nr.: 70074

Nal'chik, , Russia

City clinical hospital #12 of Sormovskiy district of Nizhniy Novgorod, Center Nr.: 70018

Nizhny Novgorod, , Russia

Privolzhsky Research Medical University, Center Nr.: 70085

Nizhny Novgorod, , Russia

Novokuznetsk City Clinical Hospital No. 1, Center Nr.: 70050

Novokuznetsk, , Russia

AVICENNA, Center Nr.: 70065

Novosibirsk, , Russia

City Clinical Polyclinic #16, Center Nr.: 70056

Novosibirsk, , Russia

Novosibirsk State Medical University, Center Nr.: 70059

Novosibirsk, , Russia

AVICENNA, Center Nr.: 70064

Novosibirsk, , Russia

Penza regional clinical hospital named after N.N. Burdenko, Center Nr.: 70095

Penza, , Russia

Private Clinic Salon Roden, Center Nr.: 70086

Perm, , Russia

City clinical hospital 5, Center Nr.: 70057

Perm, , Russia

City clinical hospital 5, Center Nr.: 70070

Perm, , Russia

City polyclinic #16 of the City Rostov-on-Don, Center Nr.: 70027

Rostov-on-Don, , Russia

North-West State Medical University named after II. Mechnikov, Center Nr.: 70053

Saint Petersbug, , Russia

North-West State Medical University named after II. Mechnikov, Center Nr.: 70077

Saint Petersbug, , Russia

First Saint-Petersburg state medical university named after acad. I.P.Pavlov, Center Nr.: 70024

Saint Petersburg, , Russia

First Saint-Petersburg state medical university named after acad. I.P.Pavlov, Center Nr.: 70087

Saint Petersburg, , Russia

Medilux-TM, Center Nr.: 70005

Saint Petersburg, , Russia

V.A. Almazov National Medical Research Center, Center Nr.: 70071

Saint Petersburg, , Russia

AntMed, Center Nr.: 70034

Saint Petersburg, , Russia

Dr. Tsiberkin, Center Nr.: 70048

Saint Petersburg, , Russia

City Pokrovskaya Hospital, Center Nr.: 70022

Saint Petersburg, , Russia

Zabotlivyi Doktor, Center Nr.: 70016

Saint Petersburg, , Russia

Samara city polyclinic Nr. 9 of Oktyabrskiy district, Center Nr.: 70028

Samara, , Russia

Samara city consulting and diagnostic polyclinic nr. 14, Center Nr.: 70029

Samara, , Russia

Clinical Hospital of the Saratov city, Center Nr.: 70090

Saratov, , Russia

LLC clinic "Family Doctor", Center Nr.: 70093

Saratov, , Russia

Multifunctional Medical Clinic "Sova", Center Nr.: 70030

Saratov, , Russia

Regional Endocrinological Dispensary, Center Nr.: 70078

Stavropol, , Russia

Tyumen State Medical University, Center Nr.: 70066

Tyumen, , Russia

City clinical hospital, Center Nr.: 70019

Ufa, , Russia

City Polyclinic No.2, Center Nr.: 70062

Ulan-Ude, , Russia

Limited Liability Company "CENTER", Center Nr.: 70060

Vladivostok, , Russia

Regional Clinical Hospital No. 2, Center Nr.: 70092

Vladivostok, , Russia

Regional Clinical Hospital No. 2, Center Nr.: 70068

Vladivostok, , Russia

Volgograd Regional Clinical Hospital No. 3, Center Nr.: 70076

Volgograd, , Russia

Clinical Polyclinic No.28, Center Nr.: 70040

Volgograd, , Russia

Voronezh City Clinical Hospital #11, Center Nr.: 70035

Voronezh, , Russia

State budgetary institution "City polyclinic Nr. 4", Center Nr.: 70017

Voronezh, , Russia

State budgetary institution "City polyclinic Nr. 4", Center Nr.: 70033

Voronezh, , Russia

State budgetary institution "City polyclinic Nr. 4", Center Nr.: 70055

Voronezh, , Russia

Limited Liability Company "Uralsky Medical Center", Center Nr.: 70063

Yekaterinburg, , Russia

Scientific and Practical Center of Specialized Types of Medical Care "Uralskij Institute of Cardiology", Center Nr.: 70079

Yekaterinburg, , Russia

Countries

Bulgaria; Czechia; Hungary; Poland; Russia

References

Prazny M, Suplotova L, Gumprecht J, Kamenov Z, Fulop T, Medvedchikov A, Rosenzweig D, Aleksandric M. Real-world characteristics, modern antidiabetic treatment patterns, and comorbidities of patients with type 2 diabetes in central and Eastern Europe: retrospective cross-sectional and longitudinal evaluations in the CORDIALLY(R) study. Cardiovasc Diabetol. 2022 Oct 8;21(1):203. doi: 10.1186/s12933-022-01631-4.

Reference Type: DERIVED

PMID: 36209118 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

1245-0187

Identifier Type: -

Identifier Source: org_study_id