A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes
NCT ID: NCT03817463
Last Updated: 2024-09-23
Study Results
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View full resultsBasic Information
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COMPLETED
327624 participants
OBSERVATIONAL
2019-04-15
2021-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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New users of SGLT-2i
Patients with type 2 diabetes mellitus (T2DM), who were new users of any sodium-glucose cotransporter-2 inhibitors (SGLT-2i) including empagliflozin.
Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor
Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor
New users of DPP-4i
Patients with type 2 diabetes mellitus (T2DM), who were new users of dipeptidyl peptidase-4 inhibitors (DPP-4i).
Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor
Dipeptidyl peptidase-4 (DPP-4) inhibitor
Interventions
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Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor
Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor
Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor
Dipeptidyl peptidase-4 (DPP-4) inhibitor
Eligibility Criteria
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Inclusion Criteria
* No dispensation or any other record of any other SGLT-2 inhibitor or DPP-4 inhibitor use during the preceding 12 months including at index date
* Having a diagnosis of T2DM before the index date, based on ICD-10 codes or other available data
Exclusion Criteria
* Type 1 diabetes mellitus
* Secondary diabetes
* Gestational diabetes
* Having a diagnosis of ESRD during the 12 months before the index date
* \<12 months of available data before the index date, and/or no complete history of drug dispensations/other records of the drug use during this period
* Missing or ambiguous data on age or sex
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Steno Diabetes Center Copenhagen, Department of Clinical Epidemiology
Gentofte Municipality, , Denmark
Helsinki University Hospital
Helsinki, , Finland
University of Ulm, Institute for Epidemiology and medical biometry
Ulm, , Germany
Maccabi Healthcare Services
Tel Aviv, , Israel
Gifu University
Gifu, , Japan
Oslo University Hospital, Department of Clinical Lipidology
Oslo, , Norway
Oslo University Hospital, Department of Cardiology
Oslo, , Norway
Ajou University Hospital
Suwon, , South Korea
Instituto de Investigación Sanitaria INCLIVA
Valencia, , Spain
TFS Trial Form Support International AB
Lund, , Sweden
Quantify Research AB
Stockholm, , Sweden
Taiwan Society for Pharmacoeconomics and Outcome Research (TaSPOR)
Taipei, , Taiwan
Leicester Real World Evidence Unit, Leicester general Hospital
Leicester, , United Kingdom
Countries
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References
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Nystrom T, Toresson Grip E, Gunnarsson J, Casajust P, Karlsdotter K, Skogsberg J, Ustyugova A; EMPRISE Study Group. Empagliflozin reduces cardiorenal events, healthcare resource use and mortality in Sweden compared to dipeptidyl peptidase-4 inhibitors: Real world evidence from the Nordic EMPRISE study. Diabetes Obes Metab. 2023 Jan;25(1):261-271. doi: 10.1111/dom.14870. Epub 2022 Oct 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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1245-0195
Identifier Type: -
Identifier Source: org_study_id
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