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)
• Enrollment: 24,500
• Location: 1
• Actual Duration (Months): 10.4
• Patients Per Site Per Month: 2345

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Empagliflozin; Drug: DPP-4i; Drug: Sitagliptin; Drug: GLP-1-RA

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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	Boehringer Ingelheim	Ingelheim am Rhein		Germany	55216

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

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: Jan 20, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Sitagliptin Phosphate; Empagliflozin

Study Results

No Results Posted as of Jan 20, 2022