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Trial · Observational

CompletedPhase not statedResults postedRegistry data

DIA_CENTRAL:T2D Treatment Pattern in Central Europe

NCTNCT03807440 (opens ClinicalTrials.gov in a new tab)Other id1245-0187
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
4,083 participants (actual)
Sponsor
Boehringer Ingelheim · Industry
Design
Not stated
Countries
5 countries

Bulgaria, Czechia, Hungary, Poland, Russia

Start
26 Aug 2019
Primary completion
31 Aug 2021
Completion
31 Aug 2021
First posted
17 Jan 2019
Last update posted
1 Dec 2023
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph –

    DIA_CENTRAL:T2D Treatment Pattern in Central Europe

    NCT03807440

    26 Aug 2019 to 31 Aug 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • EmpagliflozinDrug
  • Sodium Glucose Transporter 2 inhibitorDrug
  • Dipeptidyl-peptidase 4 inhibitorDrug
  • Glucagon-like peptide 1 agonistDrug

Arms1

  • Other

    Subjects with Diabetes Mellitus, Type 2

Primary outcomes30

Outcomes the sponsor listed as primary.

  1. Number of Patients in Each Category of First Prescription of a Respective Modern Type 2 Diabetes (T2D) Medication According to Prescribing Specialist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients in each category of prescription of a respective modern Type 2 Diabetes (T2D) medication according to prescribing specialist is reported.

  2. Number of Patients Initiated on a Modern Type 2 Diabetes (T2D) Medication Who Also Received Concomitant T2D Medications at Study Index Date 1 According to Prescribing Specialist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients initiated on a modern type 2 diabetes (T2D) medication who also received concomitant T2D medications at study index date 1 according to prescribing specialist is reported. The concomitant T2D medications reported are: * Metformin * Sulfonylurea * Acarbose * Pioglitazone * Insulin * Others

  3. Number of Patients Initiated on a Modern Type 2 Diabetes (T2D) Medication Who Also Received Concomitant Cardiovascular Disease (CVD) and/or Chronic Kidney Disease (CKD) Medication at Study Index Date 1 According to Prescribing Specialist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients initiated on a modern type 2 diabetes (T2D) medication who also received concomitant cardiovascular disease (CVD) and/or chronic kidney disease (CKD) medication at study index date 1 according to prescribing specialist is reported. The reported concomitant CVD and/or chronic CKD medications are: * Antihypertensive angiotensin-converting-enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARBs) * Statins * Low dose aspirin * Beta blockers * Diuretics * Others

  4. Baseline Characteristic: Age According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Baseline characteristic: Age according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported. Age for each patient was calculated by subtracting the year of birth from the year of registration (i.e. Year of registration - Year of birth). Year of registration was defined as the year the patients where initiated on T2D medication.

  5. Baseline Characteristic: Number of Patients in Each Category of Gender According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Baseline characteristic: Number of patients in each category of gender according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported. The reported categories of gender are: * Female * Male

  6. Baseline Characteristic: Body Mass Index (BMI) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Baseline characteristic: Body mass index (BMI) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported. Body mass index (BMI) is weight in kilograms divided by height in meters squared (kilogram/meter\^2 (kg/m\^2)).

  7. Baseline Characteristic: Number of Patients in Each Category of Race According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Baseline characteristic: Number of patients in each category of race according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported. The reported categories of race are: * Black * Non-black

  8. Baseline Characteristic: Age According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Baseline characteristic: Age according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported. Age for each patient was calculated by subtracting the year of birth from the year of registration (i.e. Year of registration - Year of birth). Year of registration was defined as the year the patients where initiated on T2D medication.

  9. Baseline Characteristic: Number of Patients in Each Category of Gender According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Baseline characteristic: Number of patients in each category of gender according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported. The reported categories of gender are: * Female * Male

  10. Body Mass Index (BMI) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Baseline characteristic: Body mass index (BMI) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported. Body mass index (BMI) is weight in kilograms divided by height in meters squared (kilogram/meter\^2 (kg/m\^2)).

  11. Baseline Characteristic: Number of Patients in Each Category of Race According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Baseline characteristic: Number of patients in each category of race according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported. The reported categories of race are: * Black * Non-black

  12. Baseline Characteristic: Age According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Baseline characteristic: Age according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported. Age for each patient was calculated by subtracting the year of birth from the year of registration (i.e. Year of registration - Year of birth). Year of registration was defined as the year the patients where initiated on T2D medication.

  13. Baseline Characteristic: Number of Patients in Each Category of Gender According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Baseline characteristic: Number of patients in each category of gender according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported. The reported categories of gender are: * Female * Male

  14. Body Mass Index (BMI) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Baseline characteristic: Body mass index (BMI) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported. Body mass index (BMI) is weight in kilograms divided by height in meters squared (kilogram/meter\^2 (kg/m\^2)).

  15. Baseline Characteristic: Number of Patients in Each Category of Race According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Baseline characteristic: Number of patients in each category of race according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported. The reported categories of race are: * Black * Non-black

  16. Time Since Diagnosis of Type 2 Diabetes (T2D) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Time since diagnosis of type 2 diabetes (T2D) according to T2D medication for the patients who were initiated on T2D medication by endocrinologist is reported. Time since diagnosis of T2D (years) was calculated by subtracting the year of T2D diagnosis from the year of registration. Year of registration was defined as the year patients where initiated on T2D medication.

  17. Time Since Diagnosis of Type 2 Diabetes (T2D) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Time since diagnosis of type 2 diabetes (T2D) according to T2D medication for the patients who were initiated on T2D medication by diabetologist is reported. Time since diagnosis of T2D (years) was calculated by subtracting the year of T2D diagnosis from the year of registration. Year of registration was defined as the year patients where initiated on T2D medication.

  18. Time Since Diagnosis of Type 2 Diabetes (T2D) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Time since diagnosis of type 2 diabetes (T2D) according to T2D medication for the patients who were initiated on T2D medication by cardiologist is reported. Time since diagnosis of T2D (years) was calculated by subtracting the year of T2D diagnosis from the year of registration. Year of registration was defined as the year patients where initiated on T2D medication.

  19. Clinical Parameter Relevant for Type 2 Diabetes (T2D): Percentage of Glycosylated Hemoglobin (HbA1c [%]) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Clinical parameter relevant for Type 2 Diabetes (T2D): Percentage of glycosylated hemoglobin (HbA1c \[%\]) according to T2D medication for the patients who were initiated on T2D medication by endocrinologist is reported.

  20. Clinical Parameter Relevant for T2D: Number of Patients in Each Category of Percentage of Glycosylated Hemoglobin (HbA1c) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Clinical parameter relevant for Type 2 Diabetes (T2D): Number of patients in each category of percentage of glycosylated hemoglobin (HbA1c) according to T2D medication for the patients who were initiated on T2D medication by endocrinologist is reported. The reported categories of percentage (%) of glycosylated hemoglobin are: * \<8.5% * ≥8.5% * Missing

  21. Clinical Parameter Relevant for Type 2 Diabetes (T2D): Percentage of Glycosylated Hemoglobin (HbA1c [%]) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Clinical parameter relevant for type 2 diabetes (T2D): Percentage of glycosylated hemoglobin (HbA1c \[%\]) according to T2D medication for the patients who were initiated on T2D medication by diabetologist is reported.

  22. Clinical Parameter Relevant for Type 2 Diabetes (T2D): Number of Patients in Each Category of Percentage of Glycosylated Hemoglobin (HbA1c) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Clinical parameter relevant for type 2 diabetes (T2D): Number of patients in each category of percentage of glycosylated hemoglobin (HbA1c) according to T2D medication for the patients who were initiated on T2D medication by diabetologist is reported. The reported categories of percentage of glycosylated hemoglobin are: * \<8.5% * ≥8.5% * Missing

  23. Clinical Parameter Relevant for Type 2 Diabetes (T2D): Percentage of Glycosylated Hemoglobin (HbA1c [%]) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Clinical parameter relevant for type 2 diabetes (T2D): Percentage of glycosylated hemoglobin (HbA1c \[%\]) according to T2D medication for the patients who were initiated on T2D medication by cardiologist is reported.

  24. Clinical Parameter Relevant for Type 2 Diabetes (T2D): Number of Patients in Each Category of Percentage of Glycosylated Hemoglobin (HbA1c) According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Clinical parameter relevant for type 2 diabetes (T2D): Number of patients in each category of percentage of glycosylated hemoglobin (HbA1c) according to T2D medication for the patients who were initiated on T2D medication by cardiologist is reported. The reported categories of percentage of glycosylated hemoglobin are: * \<8.5% * ≥8.5% * Missing

  25. 10-year Risk for Fatal Cardiovascular Disease (CVD) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    10-year risk for fatal cardiovascular disease (CVD) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported. 10-year risk for fatal CVD was calculated according to the applying Systematic COronary Risk Evaluation (SCORE) Risk Chart (European Society of Cardiology) which takes into account patient´s age, gender, systolic blood pressure, smoking status, and total cholesterol value at index date 1. SCORE Risk Chart takes values from from 0% to 100%. SCORE Risk Chart values from 5% and upwards indicate a high 10-year risk for a fatal cardiovascular event.

  26. 10-year Risk for Fatal Cardiovascular Disease (CVD) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    10-year risk for fatal cardiovascular disease (CVD) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported. 10-year risk for fatal CVD was calculated according to the applying Systematic COronary Risk Evaluation (SCORE) Risk Chart (European Society of Cardiology) which takes into account patient´s age, gender, systolic blood pressure, smoking status, and total cholesterol value at index date 1. SCORE Risk Chart takes values from from 0% to 100%. SCORE Risk Chart values from 5% and upwards indicate a high 10-year risk for a fatal cardiovascular event.

  27. 10-year Risk for Fatal Cardiovascular Disease (CVD) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    10-year risk for fatal cardiovascular disease (CVD) according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported. 10-year risk for fatal CVD was calculated according to the applying Systematic COronary Risk Evaluation (SCORE) Risk Chart (European Society of Cardiology) which takes into account patient´s age, gender, systolic blood pressure, smoking status, and total cholesterol value at index date 1. SCORE Risk Chart takes values from from 0% to 100%. SCORE Risk Chart values from 5% and upwards indicate a high 10-year risk for a fatal cardiovascular event.

  28. Number of Patients Per Type of Medical Specialty of Other Physicians Involved in Treatment Decision According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients per type of medical specialty of other physicians involved in treatment decision according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported.

  29. Number of Patients Per Type of Medical Specialty of Other Physicians Involved in Treatment Decision According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients per type of medical specialty of other physicians involved in treatment decision according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported.

  30. Number of Patients Per Type of Medical Specialty of Other Physicians Involved in Treatment Decision According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients per type of medical specialty of other physicians involved in treatment decision according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported.

Secondary outcomes(20)

  1. Number of Patients With Any Type of Cardiovascular Disease (CVD)

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients with cardiovascular disease (CVD) is reported. Patients with cardiovascular disease were considered patients for whom 'History of acute myocardial infarction', 'History of cardiology intervention', 'Ischemic heart disease', 'Congestive heart failure', 'History of stroke' or 'Peripheral arterial disease', were documented as comorbidities.

  2. Number of Patients With Chronic Kidney Disease (CKD) by Physician's Assessment

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients with chronic kidney disease (CKD) by physician's assessment (patients for whom CKD was reported as a comorbidity) is reported.

  3. Number of Patients With Documentation of Estimated Glomerular Filtration Rate (eGFR) / Urine Albumin Creatinine Ratio (UACR) Status

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients with documentation of estimated Glomerular Filtration Rate (eGFR) / Urine Albumin Creatinine Ratio (UACR) status is reported.

  4. Number of Patients With Chronic Kidney Disease (CKD) by Estimated Glomerular Filtration Rate (eGFR) and Urine Albumin Creatinine Ratio (UACR) Status

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients with Chronic Kidney Disease (CKD) by estimated Glomerular Filtration Rate (eGFR) and Urine Albumin Creatinine Ratio (UACR) status is reported.

  5. Number of Patients in Each Category of the Different Types of Cardiovascular Disease

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients in each category of the different types of cardiovascular disease is reported. The following types of cardiovascular diseases are reported: * Myocardial infarction * Cardiology intervention (Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG)) * Ischemic heart disease * Congestive heart failure * Stroke * Peripheral arterial disease The categories reported for each type of cardiovascular disease are: * Yes * No * Unknown

  6. Number of Patients in Each Category of the Different Types of Congestive Heart Failure (CHF) - Confirmed by Echocardiography

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients in each category of the different types of congestive heart failure (CHF) which was confirmed by echocardiography is reported. The reported categories of congestive heart failure confirmed by echocardiography are: * Yes * No * Unknown

  7. Number of Patients With Any Type of Cardiovascular Disease (CVD) and Without CVD According to Prescribing Specialist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients with any type of cardiovascular disease (CVD) or without CVD according to prescribing specialist is reported. Patients with cardiovascular disease were considered patients for whom 'History of acute myocardial infarction', 'History of cardiology intervention', 'Ischemic heart disease', 'Congestive heart failure', 'History of stroke' or 'Peripheral arterial disease', were documented as comorbidities.

  8. Number of Patients With Chronic Kidney (CKD) (Patients for Whom CKD Was Reported as a Comorbidity) or Without CKD by Physician's Assessment According to Prescribing Specialist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients with chronic kidney (CKD) and without CKD by physician's assessment according to prescribing specialist is reported.

  9. Number of Patients With Chronic Kidney Disease (CKD) by eGFR and UACR Status According to Prescribing Specialist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients with chronic kidney disease (CKD) by estimated Glomerular Filtration Rate (eGFR) and Urine Albumin Creatinine Ratio (UACR) status - according to prescribing specialist is reported.

  10. Number of Patients With or Without at Least One Cardiovascular Disease (CVD) Type According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients with or without at least one cardiovascular disease (CVD) type according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported. Patients with cardiovascular disease were considered patients for whom 'History of acute myocardial infarction', 'History of cardiology intervention', 'Ischemic heart disease', 'Congestive heart failure', 'History of stroke' or 'Peripheral arterial disease', were documented as comorbidities.

  11. Number of Patients in Each Category of Different Types of Cardiovascular Disease (CVD) According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients in each category of different types of cardiovascular disease (CVD) according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported. The following types of cardiovascular diseases are reported: * Myocardial infarction * Cardiology intervention (Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG)) * Ischemic heart disease * Congestive heart failure * Stroke * Peripheral arterial disease The categories reported for each type of cardiovascular disease are: * Yes * No * Unknown

  12. Number of Patients in Each Category of Congestive Heart Failure (CHF) Confirmed by Echocardiography According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients in each category of congestive heart failure (CHF) confirmed by echocardiography according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported.

  13. Number of Patients With or Without at Least One Cardiovascular Disease (CVD) Type According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication From by Endocrinologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients with or without at least one cardiovascular disease (CVD) type according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported. Patients with cardiovascular disease were considered patients for whom 'History of acute myocardial infarction', 'History of cardiology intervention', 'Ischemic heart disease', 'Congestive heart failure', 'History of stroke' or 'Peripheral arterial disease', were documented as comorbidities.

  14. Number of Patients With or Without at Least One Cardiovascular Disease (CVD) Type According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients with or without at least one cardiovascular disease (CVD) type according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported. Patients with cardiovascular disease were considered patients for whom 'History of acute myocardial infarction', 'History of cardiology intervention', 'Ischemic heart disease', 'Congestive heart failure', 'History of stroke' or 'Peripheral arterial disease', were documented as comorbidities.

  15. Number of Patients With or Without at Least One Cardiovascular Disease (CVD) Type According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients with or without at least one cardiovascular disease (CVD) type according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported. Patients with cardiovascular disease were considered patients for whom 'History of acute myocardial infarction', 'History of cardiology intervention', 'Ischemic heart disease', 'Congestive heart failure', 'History of stroke' or 'Peripheral arterial disease', were documented as comorbidities.

  16. Number of Patients With Chronic Kidney (CKD) or Without CKD by Physician's Assessment According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients with chronic kidney (CKD) (patients for whom CKD was reported as a comorbidity) or without CKD by physician's assessment according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported.

  17. Number of Patients With Chronic Kidney (CKD) and Without CKD by eGFR and UACR Status According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients with chronic kidney (CKD) (patients for whom CKD was reported as a comorbidity) and without CKD by estimated Glomerular Filtration Rate (eGFR) and Urine Albumin Creatinine Ratio (UACR) status according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported.

  18. Number of Patients in Each Category of Employment Status According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients in each category of employment status according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported. The categories of employment status are: * Employed * Not employed * Unknown

  19. Number of Patients in Each Category of Family Status According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients in each category of family status according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported. The categories of family status are: * Single * Married * Divorced * Widowed * Unknown

  20. Number of Patients in Each Category of Insurance Status According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1

    Time frame · At study index date 1 (i.e. between September 2018 and December 2018).

    Registry description

    Number of patients in each category of insurance status according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported. The categories of insurance status are: * Not insured * Statutory insured * Privately insured * Unknown

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· At study index date 1 (i.e. between September 2018 and December 2018).

Number of Patients in Each Category of First Prescription of a Respective Modern Type 2 Diabetes (T2D) Medication According to Prescribing Specialist

GroupValue (Participants)
Patients Initiated on T2D Medication by Endocrinologist815
Patients Initiated on T2D Medication by Diabetologist1073
Patients Initiated on T2D Medication by Cardiologist78
Primary outcomeCount of participants· At study index date 1 (i.e. between September 2018 and December 2018).

Number of Patients Initiated on a Modern Type 2 Diabetes (T2D) Medication Who Also Received Concomitant T2D Medications at Study Index Date 1 According to Prescribing Specialist

GroupValue (Participants)
Patients Initiated on T2D Medication by Endocrinologist1349
Patients Initiated on T2D Medication by Diabetologist1794
Patients Initiated on T2D Medication by Cardiologist81
Primary outcomeCount of participants· At study index date 1 (i.e. between September 2018 and December 2018).

Number of Patients Initiated on a Modern Type 2 Diabetes (T2D) Medication Who Also Received Concomitant Cardiovascular Disease (CVD) and/or Chronic Kidney Disease (CKD) Medication at Study Index Date 1 According to Prescribing Specialist

GroupValue (Participants)
Patients Initiated on T2D Medication by Endocrinologist1256
Patients Initiated on T2D Medication by Diabetologist1536
Patients Initiated on T2D Medication by Cardiologist87
Primary outcomeMean· At study index date 1 (i.e. between September 2018 and December 2018).

Baseline Characteristic: Age According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist

GroupValue (Years)Spread
Patients Initiated on Empagliflozin by Endocrinologist61.59.7
Patients Initiated on DPP4i by Endocrinologist65.310.4
Patients Initiated on GLP-1 RA by Endocrinologist55.810.5
Patients Initiated on Other SGLT2i by Endocrinologist62.09.2
Primary outcomeCount of participants· At study index date 1 (i.e. between September 2018 and December 2018).

Baseline Characteristic: Number of Patients in Each Category of Gender According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist

GroupValue (Participants)
Patients Initiated on Empagliflozin by Endocrinologist432
Patients Initiated on DPP4i by Endocrinologist334
Patients Initiated on GLP-1 RA by Endocrinologist37
Patients Initiated on Other SGLT2i by Endocrinologist140
Primary outcomeMean· At study index date 1 (i.e. between September 2018 and December 2018).

Baseline Characteristic: Body Mass Index (BMI) According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist

GroupValue (kilogram/meter^2 (kg/m^2))Spread
Patients Initiated on Empagliflozin by Endocrinologist33.35.4
Patients Initiated on DPP4i by Endocrinologist31.35.2
Patients Initiated on GLP-1 RA by Endocrinologist36.75.9
Patients Initiated on Other SGLT2i by Endocrinologist34.35.8
Primary outcomeCount of participants· At study index date 1 (i.e. between September 2018 and December 2018).

Baseline Characteristic: Number of Patients in Each Category of Race According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist

GroupValue (Participants)
Patients Initiated on Empagliflozin by Endocrinologist10
Patients Initiated on DPP4i by Endocrinologist7
Patients Initiated on GLP-1 RA by Endocrinologist1
Patients Initiated on Other SGLT2i by Endocrinologist5
Primary outcomeMean· At study index date 1 (i.e. between September 2018 and December 2018).

Baseline Characteristic: Age According to Type 2 Diabetes (T2D) Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist

GroupValue (Years)Spread
Patients Initiated on Empagliflozin by Diabetologist63.09.4
Patients Initiated on DPP4i by Diabetologist67.211.0
Patients Initiated on GLP-1 RA by Diabetologist59.210.8
Patients Initiated on Other SGLT2i by Diabetologist62.39.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
T2D Patients From Central Eastern EuropePatients with type 2 diabetes (T2D) from Central Eastern Europe (CEE) (Bulgaria, Czech Republic, Hungary, Poland and the Russian Federation) who were newly initiated (first ever use) on empagliflozin or other sodium dependent glucose transporter inhibitor (SGLT2i), dipeptidyl peptidase 4 inhibitor (DPP4i) or glucagon-like peptide-1 receptor agonist (GLP-1 RA) between September 2018 and December 2018 (study index date 1).0 / 405543 / 40550 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedPrazny 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. PMID 36209118

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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