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NCT04295005 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
The Empagliflozin vs. DPP-4 Inhibitors and GLP-1 Receptor Agonists Cost of Care Study: a German Claims Data Analysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04295005
Other study ID # 1245-0221
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 16, 2020
Est. completion date September 30, 2021

Study information
Verified date January 2022
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 24500
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Empagliflozin
film coated tablet
• DPP-4i
film coated tablets
• Sitagliptin
film coated tablet
• GLP-1-RA
subcutaneous injection or tablet

Locations
Country Name City State
Germany Boehringer Ingelheim Ingelheim am Rhein

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Direct healthcare cost (hospital cost, outpatient cost, drug cost, remedies and aids cost) up to 48 months
Primary Indirect healthcare cost up to 48 months
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