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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Empagliflozin

• Registration Number: NCT04098575
• Lead Sponsor: Boehringer Ingelheim

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-16
• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-23
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Results First Submitted: 2020-12-21
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-26
• Last Update Submitted: 2021-03-26
• Results First Posted: 2021-03-29
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9571

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities	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.
Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications	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).
Percentage of Participants With Antidiabetic and Cardiovascular Co-medication	At baseline.	Percentage of participants with antidiabetic and cardiovascular co-medication, including lipid-lowering agents, other antihypertensives, antiplatelets and anticoagulants.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants by Age Category	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).
Percentage of Male Participants	At baseline.	The percentage of male participants is reported.
Weight of Participants	At baseline.	Weight of participants.
Height of Participants	At baseline.	Height of participants.
Glycated Hemoglobin (HbA1c)	At baseline.	Glycated hemoglobin (HbA1c).
Duration of Diabetes	At baseline.	Duration of diabetes (time since diagnosis).
Percentage of Participants With Previous Glucose-lowering Treatment	At baseline.	Percentage of participants with glucose-lowering treatment prior to empagliflozin initiation.
Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes	At baseline.	Percentage of patients participated in Disease Management Programme (DMP) Type 2 Diabetes.
Number of Participants With Hospitalizations	At baseline.	Number of participants with hospitalizations.
Dosage of Empagliflozin	At baseline.	Dosage of empagliflozin. Number of patients on 10 milligram versus patients on 25 milligram empagliflozin.
Fasting Plasma Glucose (FPG)	At baseline.	Fasting plasma glucose (FPG).

Trial Locations

Locations (1)

Diabetes Agenda 2010 GmbH; 🇩🇪 Mahlow, Germany