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Completed

NCT Number: NCT04295005

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim

Ingelheim, 55216, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Empagliflozin

Drug

film coated tablet

DPP-4i

Drug

film coated tablets, specifically Sitagliptin

GLP-1-RA

Drug

subcutaneous injection or tablet

Primary outcomes

  1. Direct Healthcare Cost

    Time frame: 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.

    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.

  2. Healthcare Resource Utilization

    Time frame: 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 includes hospitalizations, hospital stays. outpatient visits, and rehabilitation stays.

Secondary outcomes

  1. Indirect Healthcare Costs (Including Indirect Costs of Days Absent From Work)

    Time frame: 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.

    Indirect healthcare costs (including indirect costs of days absent from work) includes indirect costs for hospitalization, outpatient visits, absent from work, and rehabilitation stays.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2020
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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