Skip to main content
OpenTrials
Completed

NCT Number: NCT04098575

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Diabetes Agenda 2010 GmbH

Mahlow, 15831, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin

Drug

drug

Primary outcomes

  1. Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities

    Time frame: At baseline.

    Percentage of patients with previous occurence of cardiovascular (CV) comorbidities, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, congestive heart failure.

  2. Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications

    Time frame: At baseline.

    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).

  3. Percentage of Participants With Antidiabetic and Cardiovascular Co-medication

    Time frame: At baseline.

    Percentage of participants with antidiabetic and cardiovascular co-medication, including lipid-lowering agents, other antihypertensives, antiplatelets and anticoagulants.

Secondary outcomes

  1. Percentage of Participants by Age Category

    Time frame: At baseline.

    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).

  2. Percentage of Male Participants

    Time frame: At baseline.

    The percentage of male participants is reported.

  3. Weight of Participants

    Time frame: At baseline.

    Weight of participants.

  4. Height of Participants

    Time frame: At baseline.

    Height of participants.

  5. Glycated Hemoglobin (HbA1c)

    Time frame: At baseline.

    Glycated hemoglobin (HbA1c).

  6. Duration of Diabetes

    Time frame: At baseline.

    Duration of diabetes (time since diagnosis).

  7. Percentage of Participants With Previous Glucose-lowering Treatment

    Time frame: At baseline.

    Percentage of participants with glucose-lowering treatment prior to empagliflozin initiation.

  8. Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes

    Time frame: At baseline.

    Percentage of patients participated in Disease Management Programme (DMP) Type 2 Diabetes.

  9. Number of Participants With Hospitalizations

    Time frame: At baseline.

    Number of participants with hospitalizations.

  10. Dosage of Empagliflozin

    Time frame: At baseline.

    Dosage of empagliflozin. Number of patients on 10 milligram versus patients on 25 milligram empagliflozin.

  11. Fasting Plasma Glucose (FPG)

    Time frame: At baseline.

    Fasting plasma glucose (FPG).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Acronym: EDCOS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 23, 2019
Registry last updated
Mar 29, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.