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

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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Empagliflozin; Drug: GLP-1-RA; Drug: DPP-4i

• Study Type: Observational
• Enrollment (Actual): 24500

Contacts and Locations

Study Locations

• Germany
  • Ingelheim am Rhein, Germany, 55216
    • Boehringer Ingelheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Type 2 diabetes mellitus (T2DM) patients who have been treated with either Empagliflozin, DPP-4i /Sitagliptin or GLP-1-RA (new users only, at least one prescription).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Empagliflozin; 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.	Drug: DPP-4i; 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.	Drug: GLP-1-RA; subcutaneous injection or tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Direct Healthcare Cost	The direct healthcare cost is reported, including inpatient cost, outpatient cost, medication cost, and total cost. Patients starting Empagliflozin (EMPA) versus either Dipeptidyl peptidase 4 inhibitor (DPP-4i), Sitagliptin (SITA) or Glucagon-like peptide-1 receptor agonist (GLP-1-RA) were matched 1:1 based on a propensity score using a nearest-neighbor matching algorithm without replacement and a maximum caliper of 0.001. The propensity scores were derived by logistic regression models estimating the probability of a patient belonging to the different treatment groups (three estimations: EMPA versus DPP-4i, EMPA versus SITA, and EMPA versus GLP-1-RA). The cost per observed patient year is calculated as the sum of the cost/ sum of the observed time [year] over all patients. Final values were rounded to the nearest digit.	Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.
Healthcare Resource Utilization	Healthcare resource utilization includes hospitalizations, hospital stays. outpatient visits, and rehabilitation stays.	Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indirect Healthcare Costs (Including Indirect Costs of Days Absent From Work)	Indirect healthcare costs (including indirect costs of days absent from work) includes indirect costs for hospitalization, outpatient visits, absent from work, and rehabilitation stays.	Dataset included all adult persons, who were continuously insured between 01 january 2014 until 31 december 2018 (except for death), approximately a 4 year period.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin
• Other Study ID Numbers: 1245-0221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No