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

NCT ID: NCT04098575

Last Updated: 2021-03-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9571 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-16

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Empagliflozin

Intervention Type DRUG

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

Empagliflozin

Intervention Type DRUG

drug

Patients receiving Empagliflozin until last available data cut

Patients receiving Empagliflozin starting from mid-Jan. 2017 until last; Cohort 3

Empagliflozin

Intervention Type DRUG

drug

Interventions

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Empagliflozin

drug

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Diabetes Agenda 2010 GmbH

Mahlow, , Germany

Site Status

Countries

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Germany

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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1245-0198

Identifier Type: -

Identifier Source: org_study_id

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