Diabetes Mellitus, Type 2 Clinical Trial
— EDCOSOfficial 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
Verified date | March 2021 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Diabetes Agenda 2010 GmbH | Mahlow |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Germany,
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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