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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Empagliflozin

• Study Type: Observational
• Enrollment (Actual): 9571

Contacts and Locations

Study Locations

• Germany
  • Mahlow, Germany, 15831
    • Diabetes Agenda 2010 GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Diabetes Mellitus, Type 2, treated with Empagliflozin

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving Empagliflozin until mid Sep 2015; Patients receiving Empagliflozin before the EMPA-REG-OUTCOME study was published time until mid-Sept. 2015; Cohort 1	Drug: Empagliflozin; drug
Patients receiving Empagliflozin until CV Label Change time; Patients receiving Empagliflozin starting from the EMPA-REG-OUTCOME study being published until CV Label Change time from mid-Sept. 2015-mid-Jan. 2017; Cohort 2	Drug: Empagliflozin; drug
Patients receiving Empagliflozin until last available data cut; Patients receiving Empagliflozin starting from mid-Jan. 2017 until last; Cohort 3	Drug: Empagliflozin; drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Percentage of Male Participants	The percentage of male participants is reported.	At baseline.
Weight of Participants	Weight of participants.	At baseline.
Height of Participants	Height of participants.	At baseline.
Glycated Hemoglobin (HbA1c)	Glycated hemoglobin (HbA1c).	At baseline.
Duration of Diabetes	Duration of diabetes (time since diagnosis).	At baseline.
Percentage of Participants With Previous Glucose-lowering Treatment	Percentage of participants with glucose-lowering treatment prior to empagliflozin initiation.	At baseline.
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.
Number of Participants With Hospitalizations	Number of participants with hospitalizations.	At baseline.
Dosage of Empagliflozin	Dosage of empagliflozin. Number of patients on 10 milligram versus patients on 25 milligram empagliflozin.	At baseline.
Fasting Plasma Glucose (FPG)	Fasting plasma glucose (FPG).	At baseline.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 16, 2019
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (ACTUAL): September 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin
• Other Study ID Numbers: 1245-0198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

1. Studies in products where Boehringer Ingelheim is not the license holder
2. Studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials
3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

Requestors can use the following link http://trials.boehringer-ingelheim.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No