A Study Based on Data From German Registries That Looks at Characteristics of People Who Take the Medicine Empagliflozin for Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— EDCOS  

Official title:

Treatment of T2DM Patients in Germany Receiving Empagliflozin: A Retrospective RWE Study Description of Treatment and Population Characteristics of Type 2 Diabetic Patients in Germany Receiving Empagliflozin: A Retrospective Real-World Evidence (RWE) Study Based on German Registries DPV&DIVE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098575
• Other study ID #: 1245-0198
• Status: Completed
• Start date: September 16, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Description of the real-life treatment of adult patients with type-2 diabetes mellitus (T2DM) receiving Empagliflozin, comparing the characteristics of patients starting Empagliflozin in three time intervals

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9571
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• At least two outpatient T2DM diagnoses (ICD E11.-) in two different quarters and/or at least one inpatient T2DM diagnosis (ICD E11)
• At least one prescription of an empagliflozin-containing antidiabetic drug: Jardiance® (Empagliflozin, ATC A10BK03, former A10BX12) or Synjardy® (Empagliflozin/ Met¬for¬min, ATC A10BD20)

Exclusion Criteria:

• Any diagnosis of T1DM

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Empagliflozin
drug

Locations

Country	Name	City	State
Germany	Diabetes Agenda 2010 GmbH	Mahlow

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities	Percentage of patients with previous occurence of cardiovascular (CV) comorbidities, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, congestive heart failure.	At baseline.
Primary	Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications	Percentage of participants with previous occurence of other typical diabetes complications, including, Neuropathy, Nephropathy, Chronic Kidney Disease, Microalbuminuria, Macroalbuminuria, estimated glomerular filtration rate (eGFR), diabetic foot syndrome, retinopathy (background and proliferative).	At baseline.
Primary	Percentage of Participants With Antidiabetic and Cardiovascular Co-medication	Percentage of participants with antidiabetic and cardiovascular co-medication, including lipid-lowering agents, other antihypertensives, antiplatelets and anticoagulants.	At baseline.
Secondary	Percentage of Participants by Age Category	Percentage of participants by age category; younger than 65 (< 65), from 65 to 74 (65 = 75) , from 75 to 80 (75 - 80) , older than 80 (> 80).	At baseline.
Secondary	Percentage of Male Participants	The percentage of male participants is reported.	At baseline.
Secondary	Weight of Participants	Weight of participants.	At baseline.
Secondary	Height of Participants	Height of participants.	At baseline.
Secondary	Glycated Hemoglobin (HbA1c)	Glycated hemoglobin (HbA1c).	At baseline.
Secondary	Duration of Diabetes	Duration of diabetes (time since diagnosis).	At baseline.
Secondary	Percentage of Participants With Previous Glucose-lowering Treatment	Percentage of participants with glucose-lowering treatment prior to empagliflozin initiation.	At baseline.
Secondary	Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes	Percentage of patients participated in Disease Management Programme (DMP) Type 2 Diabetes.	At baseline.
Secondary	Number of Participants With Hospitalizations	Number of participants with hospitalizations.	At baseline.
Secondary	Dosage of Empagliflozin	Dosage of empagliflozin. Number of patients on 10 milligram versus patients on 25 milligram empagliflozin.	At baseline.
Secondary	Fasting Plasma Glucose (FPG)	Fasting plasma glucose (FPG).	At baseline.

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