Empagliflozin
DrugEmpagliflozin
Other names: Jardiance® Synjardy® Trajenta® Jentadueto®
Completed
NCT Number: NCT03807440
DIA_CENTRAL:T2D Treatment Pattern in Central Europe
This is a non-interventional study using existing data including medical chart review.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
MHAT "Julia Verevska-Byala" EOOD, Center Nr.: 35903, Byala, Bulgaria
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Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Written informed consent prior to participation
- Female and male patients age ≥ 18 years
- Patients with T2D diagnosis
- 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)
- 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
- Patients age < 18 years
- Patients with diagnosis of other types of diabetes than T2D
- Patients who do not provide written consent to the terms of the study
Treatment and study plan
Sodium Glucose Transporter 2 inhibitor
DrugSodium Glucose Transporter 2 inhibitor
Other names: Jardiance® Synjardy® Trajenta® Jentadueto®
Dipeptidyl-peptidase 4 inhibitor
DrugDipeptidyl-peptidase 4 inhibitor
Other names: Jardiance® Synjardy® Trajenta® Jentadueto®
Glucagon-like peptide 1 agonist
DrugGlucagon-like peptide 1 agonist
Other names: Jardiance® Synjardy® Trajenta® Jentadueto®
Primary outcomes
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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).
Number of patients in each category of prescription of a respective modern Type 2 Diabetes (T2D) medication according to prescribing specialist is reported.
-
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).
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
-
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).
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
-
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).
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.
-
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).
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
-
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).
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)).
-
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).
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
-
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).
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.
-
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).
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
-
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).
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)).
-
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).
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
-
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).
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.
-
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).
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
-
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).
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)).
-
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).
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
-
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).
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.
-
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).
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.
-
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).
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.
-
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).
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.
-
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).
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
-
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).
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.
-
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).
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
-
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).
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.
-
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).
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
-
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).
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.
-
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).
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.
-
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).
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.
-
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).
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.
-
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).
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.
-
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).
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
-
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).
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.
-
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).
Number of patients with chronic kidney disease (CKD) by physician's assessment (patients for whom CKD was reported as a comorbidity) is reported.
-
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).
Number of patients with documentation of estimated Glomerular Filtration Rate (eGFR) / Urine Albumin Creatinine Ratio (UACR) status is reported.
-
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).
Number of patients with Chronic Kidney Disease (CKD) by estimated Glomerular Filtration Rate (eGFR) and Urine Albumin Creatinine Ratio (UACR) status is reported.
-
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).
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
-
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).
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
-
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).
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.
-
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).
Number of patients with chronic kidney (CKD) and without CKD by physician's assessment according to prescribing specialist is reported.
-
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).
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.
-
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).
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.
-
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).
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
-
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).
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.
-
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).
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.
-
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).
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.
-
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).
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.
-
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).
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.
-
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).
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.
-
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).
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
-
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).
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
-
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).
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
-
Number of Patients in Each Category of Employment Status 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).
Number of patients in each category of employment status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported.
The categories of employment status are:
- Employed
- Not employed
- Unknown
-
Number of Patients in Each Category of Family Status 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).
Number of patients in each category of family status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported.
The categories of family status are:
- Single
- Married
- Divorced
- Widowed
- Unknown
-
Number of Patients in Each Category of Insurance Status 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).
Number of patients in each category of insurance status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by endocrinologist is reported.
The categories of insurance status are:
- Not insured
- Statutory insured
- Privately insured
- Unknown
-
Number of Patients in Each Category of Employment Status 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).
Number of patients in each category of employment status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported.
The categories of employment status are:
- Employed
- Not employed
- Unknown
-
Number of Patients in Each Category of Family Status 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).
Number of patients in each category of family status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported.
The categories of family status are:
- Single
- Married
- Divorced
- Widowed
- Unknown
-
Number of Patients in Each Category of Insurance Status 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).
Number of patients in each category of insurance status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by diabetologist is reported.
The categories of insurance status are:
- Not insured
- Statutory insured
- Privately insured
- Unknown
-
Number of Patients in Each Category of Employment Status 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).
Number of patients in each category of employment status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported.
The categories of employment status are:
- Employed
- Not employed
- Unknown
-
Number of Patients in Each Category of Family Status 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).
Number of patients in each category of family status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported.
The categories of family status are:
- Single
- Married
- Divorced
- Widowed
- Unknown
-
Number of Patients in Each Category of Insurance Status 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).
Number of patients in each category of insurance status according to type 2 diabetes (T2D) medication for the patients who were initiated on T2D medication by cardiologist is reported.
The categories of insurance status are:
- Not insured
- Statutory insured
- Privately insured
- Unknown
-
Number of Patients in Each Category of Status of Type 2 Diabetes (T2D) Medication at Index Date 2 According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of patients in each category of status of type 2 diabetes (T2D) medication at index date 2 according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported.
The categories of status of T2D medication are:
- Discontinued
- Continued
-
Number of Patients in Each Category of Status of Type 2 Diabetes (T2D) Medication at Index Date 2 According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Endocrinologist
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of patients in each category of status of type 2 diabetes (T2D) medication at index date 2 according to T2D medication for the patients who were initiated on T2D medication by endocrinologist is reported.
The categories of status of T2D medication are:
- Discontinued
- Continued
-
Number of Patients in Each Category of Status of Type 2 Diabetes (T2D) Medication at Index Date 2 According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of patients in each category of status of type 2 diabetes (T2D) medication at index date 2 according to T2D medication for the patients who were initiated on T2D medication by diabetologist is reported.
The categories of status of T2D medication are:
- Discontinued
- Continued
-
Number of Patients in Each Category of Status of Type 2 Diabetes (T2D) Medication at Index Date 2 According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of patients in each category of status of type 2 diabetes (T2D) medication at index date 2 according to T2D medication for the patients who were initiated on T2D medication by cardiologist is reported.
The categories of status of T2D medication are:
- Discontinued
- Continued
-
Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) Medication by Country
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of patients in each category of reason for discontinuation of type 2 diabetes (T2D) medication by country is reported.
The categories of reason for discontinuation of T2D medication are:
- Lack of efficacy
- Medication administration
- Financial burden regarding co-payment
- Lost to follow-up
- Adverse event
- Other
-
Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) Medication According to Type 2 Diabetes (T2D) Medication Initiated at Study Index Date 1
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of patients in each category of reason for discontinuation of type 2 diabetes (T2D) medication according to type 2 diabetes (T2D) medication initiated at study index date 1 is reported.
The categories of reason for discontinuation of T2D medication are:
- Lack of efficacy
- Medication administration
- Financial burden regarding co-payment
- Lost to follow-up
- Adverse event
- Other
-
Number of Patients in Each Category of Reason for Discontinuation 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 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of patients in each category of reason for discontinuation of type 2 diabetes (T2D) according to T2D medication for the patients who were initiated on T2D medication by endocrinologist is reported.
The categories of reason for discontinuation of T2D medication are:
- Lack of efficacy
- Medication administration
- Financial burden regarding co-payment
- Lost to follow-up
- Adverse event
- Other
-
Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) Medication According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Diabetologist
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of patients in each category of reason for discontinuation of type 2 diabetes (T2D) medication according to T2D medication for the patients who were initiated on T2D medication by diabetologist is reported.
The categories of reason for discontinuation of T2D medication are:
- Lack of efficacy
- Medication administration
- Financial burden regarding co-payment
- Lost to follow-up
- Adverse event
- Other
-
Number of Patients in Each Category of Reason for Discontinuation of Type 2 Diabetes (T2D) Medication According to T2D Medication for the Patients Who Were Initiated on T2D Medication by Cardiologist
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of patients in each category of reason for discontinuation of type 2 diabetes (T2D) medication according to T2D medication for the patients who were initiated on T2D medication by cardiologist is reported.
The categories of reason for discontinuation of T2D medication are:
- Lack of efficacy
- Medication administration
- Financial burden regarding co-payment
- Lost to follow-up
- Adverse event
- Other
-
Number of Patients for Each Type of Physician Specialties Involved in Decision for T2D Therapy Discontinuation According to Prescribing Specialist
Time frame: At study index date 2 (= one year ± 2 months after index date 1 (study index date 1 was between September 2018 and December 2018)).
Number of patients for each type of physician specialties involved in decision for T2D therapy discontinuation according to prescribing specialist is reported.
-
Time to Discontinuation of Type 2 Diabetes (T2D) Treatment According to Study Medication
Time frame: From date of first prescription (study index date 1) to stop date of initial type 2 diabetes (T2D)) medication (documented at index date 2), up to 14 months..
Time to discontinuation of type 2 diabetes (T2D) treatment according to study medication is reported.
Time to discontinuation of T2D medication was estimated by Kaplan-Meier analysis. Patients who did not discontinue study medication at study index date 2 were censored.
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2019
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Jan 17, 2019
- Registry last updated
- Dec 1, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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