- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
The Empagliflozin vs. DPP-4 Inhibitors and GLP-1 Receptor Agonists Cost of Care Study: a German Claims Data Analysis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ingelheim am Rhein, Germany, 55216
- Boehringer Ingelheim
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
All patients who started an Empagliflozin therapy
|
film coated tablet
|
All patients who started a DPP-4 inhibitor therapy
|
film coated tablets
|
All patients who started a Sitagliptin therapy
|
film coated tablet
|
All patients who started a GLP-1 receptor agonist therapy
|
subcutaneous injection or tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Direct healthcare cost
Time Frame: up to 48 months
|
(hospital cost, outpatient cost, drug cost, remedies and aids cost)
|
up to 48 months
|
Indirect healthcare cost
Time Frame: up to 48 months
|
up to 48 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Sodium-Glucose Transporter 2 Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Empagliflozin
- Sitagliptin Phosphate
Other Study ID Numbers
- 1245-0221
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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