A Study Based on Data From German Sick Funds That Looks at the Costs of Treatment of Type-2 Diabetic Patients With Empagliflozin vs. DPP-4 Inhibitors vs. GLP-1 Receptor Agonists

NCT ID: NCT04295005

Last Updated: 2024-08-30

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-16

Study Completion Date

2021-09-30

Brief Summary

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Empagliflozin vs. Dipeptidyl Peptidase 4 (DPP-4) Inhibitors and Glucagon-like Peptide-1 Receptor Agonists (GLP-1-RA) Cost of Care Study: a German claims data analysis

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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All patients who started an Empagliflozin therapy

All participants who met the inclusion criteria and none of the exclusion criteria of this study, who had at least two outpatient diagnoses and/or one inpatient diagnosis of Type 2 diabetes mellitus (T2DM) and received at least one outpatient prescription with Empagliflozin (EMPA) between 2015 - 2018 from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset.

Empagliflozin

Intervention Type DRUG

film coated tablet

All patients who started a DPP-4 inhibitor (specifically Sitagliptin) therapy

All participants who met the inclusion criteria and none of the exclusion criteria of this study, who had at least two outpatient diagnoses and/or one inpatient diagnosis of Type 2 diabetes mellitus (T2DM) and received at least one outpatient prescription with Dipeptidyl peptidase 4 (DPP-4) inhibitor (DPP-4i) (specifically Sitagliptin) between 2015 - 2018 from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset.

DPP-4i

Intervention Type DRUG

film coated tablets, specifically Sitagliptin

All patients who started a GLP-1 receptor agonist therapy

All participants who met the inclusion criteria and none of the exclusion criteria of this study, who had at least two outpatient diagnoses and/or one inpatient diagnosis of Type 2 diabetes mellitus (T2DM) and received at least one outpatient prescription with Glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1-RA) between 2015 - 2018 from the Gesellschaft für Qualität und Wirtschaftlichkeit bei Krankenkassen (GWQ) dataset.

GLP-1-RA

Intervention Type DRUG

subcutaneous injection or tablet

Interventions

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Empagliflozin

film coated tablet

Intervention Type DRUG

DPP-4i

film coated tablets, specifically Sitagliptin

Intervention Type DRUG

GLP-1-RA

subcutaneous injection or tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Continuous insurance by the sickness fund for the entire period (01/01/2014 - 31/12/2018; death of a patient is the only accepted exception from this rule)
* At least two outpatient T2DM diagnoses (ICD E11.-) in two different quarters and/or at least one inpatient T2DM diagnosis (ICD E11.-) in the period 01/01/2014 to 31/12/2016, but before or on index date (i.e. first Empagliflozin or DPP-4i /Sitagliptin prescription).
* At least one prescription of Empagliflozin or a DPP-4i /Sitagliptin in the inclusion period (01/01/2015 - 31/12/2016)

Exclusion Criteria

* At least one prescription of a sodium glucose transporter 2 inhibitor (SGLT-2i), DPP-4i or GLP-1-RA in the baseline period (01/01/2014 - 31/12/2014)

* During follow-up, patients will be censored if they switch to any SGLT-2i, DPP-4i or GLP-1-RA or initiate a concomitant use of any SGLT-2i, DPP-4i or GLP-1-RA (free or fixed-dose combinations).
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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Boehringer Ingelheim

Ingelheim, , 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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1245-0221

Identifier Type: -

Identifier Source: org_study_id

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