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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT04295005
Collaborator
(none)
24,500
Enrollment
1
Location
10.4
Actual Duration (Months)
2345
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Study Design

Study Type:
Observational
Actual Enrollment :
24500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Empagliflozin vs. DPP-4 Inhibitors and GLP-1 Receptor Agonists Cost of Care Study: a German Claims Data Analysis
Actual Study Start Date :
Nov 16, 2020
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

ArmIntervention/Treatment
All patients who started an Empagliflozin therapy

Drug: Empagliflozin
film coated tablet

All patients who started a DPP-4 inhibitor therapy

Drug: DPP-4i
film coated tablets

All patients who started a Sitagliptin therapy

Drug: Sitagliptin
film coated tablet

All patients who started a GLP-1 receptor agonist therapy

Drug: GLP-1-RA
subcutaneous injection or tablet

Outcome Measures

Primary Outcome Measures

  1. Direct healthcare cost [up to 48 months]

    (hospital cost, outpatient cost, drug cost, remedies and aids cost)

  2. Indirect healthcare cost [up to 48 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Boehringer IngelheimIngelheim am RheinGermany55216

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT04295005
Other Study ID Numbers:
  • 1245-0221
First Posted:
Mar 4, 2020
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021