A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Multi-country Non-interventional Study on the Effectiveness of Empagliflozin in Adult Patients With Type 2 Diabetes in Europe and Asia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03817463
• Other study ID #: 1245-0195
• Status: Completed
• Start date: April 15, 2019
• Est. completion date: December 10, 2021

Study information

• Verified date: January 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of Type 2 diabetes mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171808
• Est. completion date: December 10, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Dispensation or any other record of empagliflozin, any SGLT-2 inhibitor, or any DPP-4 inhibitor use during the study period
• 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:

• Aged <18 years on the first dispensation date or date of the first record of empagliflozin, any SGLT-2 inhibitor or any DPP-4 inhibitor use
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen, Department of Clinical Epidemiology	Gentofte
Finland	Helsinki University Hospital	Helsinki
Germany	University of Ulm, Institute for Epidemiology and medical biometry	Ulm
Israel	Maccabi Healthcare Services	Tel Aviv
Japan	Gifu University	Gifu
Korea, Republic of	Ajou University Hospital	Suwon
Norway	Oslo University Hospital, Department of Cardiology	Oslo
Norway	Oslo University Hospital, Department of Clinical Lipidology	Oslo
Spain	Instituto de Investigación Sanitaria INCLIVA	Valencia
Sweden	TFS Trial Form Support International AB	Lund
Sweden	Quantify Research AB	Stockholm
Taiwan	Taiwan Society for Pharmacoeconomics and Outcome Research (TaSPOR)	Taipei City
United Kingdom	Leicester Real World Evidence Unit, Leicester general Hospital	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Denmark,  Finland,  Germany,  Israel,  Japan,  Korea, Republic of,  Norway,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants hospitalized for heart failure		up to 4.5 years
Primary	Number of participants with all-cause mortality		up to 4.5 years
Primary	Number of participants with both hospitalization for heart failure and all cause mortality		up to 4.5 years
Primary	Number of participants with myocardial infraction (MI), stroke, all cause mortality		up to 4.5 years
Secondary	Number of participants with Cardiovascular mortality		up to 4.5 years
Secondary	Number of participants with a composite outcome including hospitalization for heart failure and cardiovascular (CV) mortality		up to 4.5 years
Secondary	Number of participants with 3-point major adverse cardiovascular (CV) events (MACE), defined as a composite outcome including myocardial infarction (MI),stroke, and cardiovascular (CV) mortality		up to 4.5 years
Secondary	Number of participants with coronary revascularization procedure		up to 4.5 years
Secondary	Number of participants with end-stage renal disease (ESRD)		up to 4.5 years
Secondary	Number of participants with estimated glomerular filtration rate (eGFR) decline		up to 4.5 years
Secondary	Number of participants with progression from normoalbuminuria to micro- or macroalbuminuria		up to 4.5 years
Secondary	Number of participants with a composite outcome including eGFR decline and progression to micro- or macroalbuminuria		up to 4.5 years
Secondary	Number of participants with bone fracture		up to 4.5 years
Secondary	Number of participants with diabetic ketoacidosis		up to 4.5 years
Secondary	Number of participants with severe hypoglycemia		up to 4.5 years
Secondary	Number of participants with lower-limb amputation		up to 4.5 years
Secondary	Number of participants with acute kidney injury requiring dialysis		up to 4.5 years
Secondary	Healthcare resource utilization		up to 4.5 years
Secondary	Cost of care	Costs of HCRU	up to 4.5 years

External Links

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