A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitorDrug: Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor
- Registration Number
- NCT03817463
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of Type 2 diabetes mellitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 171808
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description New users of SGLT-2i Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor Patients with type 2 diabetes mellitus (T2DM), who were new users of any sodium-glucose cotransporter-2 inhibitors (SGLT-2i) including empagliflozin. New users of DPP-4i Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor Patients with type 2 diabetes mellitus (T2DM), who were new users of dipeptidyl peptidase-4 inhibitors (DPP-4i).
- Primary Outcome Measures
Name Time Method Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i Number of participants with Hospitalization for Heart Failure (HHF), using broad + specific HHF definition.
HHF - broad defined as any diagnosis associated with healthcare encounters, including hospitalizations and specialist outpatient and primary care encounters, or dispensation or any other record of the high-ceiling diuretics (loop diuretics).
HHF - specific defined as a primary diagnosis associated with hospital admission.
For HHF - broad + specific, HHF-specific definition was used unless only broad definition were available. However, for Japan South Korea and Taiwan, both definitions were available, but broad definition was used.Number of Participants With Hospitalization for Heart Failure (HHF), Broad Definition From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i Reported is the number of participants with hospitalization for heart failure (HHF), using broad definition of HHF.
HHF - broad is defined as any diagnosis associated with healthcare encounters, including hospitalizations and specialist outpatient and primary care encounters, or dispensation or any other record of the high-ceiling diuretics (loop diuretics).Number of Participants With Hospitalization for Heart Failure (HHF), Specific Definition From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i Reported is the number of participants with hospitalization for heart failure, using specific definition for HHF.
HHF - specific defined as a primary diagnosis associated with hospital admission.Number of Participants With All-cause Mortality (ACM) From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. Number of participants with all-cause mortality (ACM).
Number of Participants With Composite Outcome, Including Hospitalization for Heart Failure (HHF) and All Cause Mortality (ACM) From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. Number of participants with composite outcome, including hospitalization for heart failure (HHF) and all cause mortality (ACM).
Number of Participants With Composite Outcome, Including Myocardial Infraction (MI), Stroke and All Cause Mortality (ACM) From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. Number of participants with composite outcome, including myocardial infraction (MI), stroke and all cause mortality (ACM).
Number of Participants With Myocardial Infarction (MI) From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. Number of participants with myocardial infarction (MI).
Number of Participants With Stroke From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. Number of participants with stroke.
- Secondary Outcome Measures
Name Time Method Healthcare Resource Utilization (HCRU): Number of Any Prescription From index date until end of follow-up, up to 67 months. HCRU data were collected from seven of the 11 participating countries including Finland, Japan, South Korea, Norway, Spain, Sweden, and Taiwan. Outcomes captured as HCRU include pharmacy dispensations/prescriptions of different antidiabetic drugs, different drugs and prescriptions.
HCRU outcomes were investigated for the matched cohort of empagliflozin/DPP-4 only. Due to possibly huge differences in healthcare systems and local practices, HCRU outcomes were presented descriptively by country as per prespecified analysis plan.
For arms with 0 patients analyzed, no data was collected for the specific outcome in this country.Total Healthcare Costs - Finland, Norway, Sweden From index date until end of follow-up, up to 67 months. Total healthcare cost include costs for emergency room visits, first inpatient stay, all-cause hospital admissions, outpatient healthcare visits and pharmacy dispensations/prescriptions of different antidiabetic drugs, different drugs and prescriptions. Total healthcare costs for Finland, Norway and Sweden are reported in Euro per year.
Due to possible huge differences in healthcare systems, cost of care outcomes are presented by country as prespecified in the analysis plan.Total Healthcare Cost - Japan From index date until end of follow-up, up to 67 months. Total healthcare costs include costs for emergency room visits, first inpatient stay, all-cause hospital admissions, outpatient healthcare visits and pharmacy dispensations/prescriptions of different antidiabetic drugs, different drugs and prescriptions.
Total healthcare cost for Japan are reported in Japanese Yen (JPY) per year.
Due to possible huge differences in healthcare systems, cost of care outcomes are presented by country as prespecified in the analysis plan.Total Healthcare Cost - South Korea From index date until end of follow-up, up to 67 months. Total healthcare costs include costs for emergency room visits, first inpatient stay, all-cause hospital admissions, outpatient healthcare visits and pharmacy dispensations/prescriptions of different antidiabetic drugs, different drugs and prescriptions.
Total healthcare costs for South Korea are reported in 1000 Korean Won (KRW) per year.
Due to possible huge differences in healthcare systems, cost of care outcomes are presented by country as prespecified in the analysis plan.Total Healthcare Cost - Taiwan From index date until end of follow-up, up to 67 months. Total healthcare costs include costs for emergency room visits, first inpatient stay, all-cause hospital admissions, outpatient healthcare visits and pharmacy dispensations/prescriptions of different antidiabetic drugs, different drugs and prescriptions.
Total healthcare cost for Taiwan are reported in United States Dollar (USD) per year.
Due to possible huge differences in healthcare systems, cost of care outcomes are presented by country as prespecified in the analysis plan.Number of Participants With Cardiovascular Mortality (CM) From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. Number of participants with cardiovascular mortality (CM).
Number of Participants With Composite Outcome Including Hospitalization for Heart Failure (HHF) and Cardiovascular (CV) Mortality From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. Number of participants with composite outcome including hospitalization for heart failure (HHF) and cardiovascular (CV) mortality.
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 From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. 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.
Number of Participants With Coronary Revascularization Procedure From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. Number of participants with coronary revascularization procedure.
Number of Participants With End-stage Renal Disease (ESRD) From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. Number of participants with end-stage renal disease (ESRD).
Number of Participants With Estimated Glomerular Filtration Rate (eGFR) Decline From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. Number of participants with estimated glomerular filtration rate (eGFR) decline.
Number of Participants With Progression From Normoalbuminuria to Micro- or Macroalbuminuria From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. Number of participants with progression from normoalbuminuria to micro- or macroalbuminuria.
Number of Participants With Composite Outcome Including eGFR Decline and Progression to Micro- or Macroalbuminuria From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i. Number of participants with composite outcome including Estimated glomerular filtration rate (eGFR) decline and progression to micro- or macroalbuminuria.
Number of Participants With Bone Fracture From index date until end of follow-up, up to 67 months. Number of participants with bone fracture. Data for this endpoint was only collected and analyzed for the matched cohort of empagliflozin/DPP-4i.
Number of Participants With Diabetic Ketoacidosis From index date until end of follow-up, up to 67 months. Number of participants with diabetic ketoacidosis. Data for this endpoint was only collected and analyzed for the matched cohort of empagliflozin/DPP-4i
Number of Participants With Severe Hypoglycemia From index date until end of follow-up, up to 67 months. Number of participants with severe hypoglycemia. Data for this endpoint was only collected and analyzed for the matched cohort of empagliflozin/DPP-4i.
Number of Participants With Lower-limb Amputation From index date until end of follow-up, up to 67 months. Number of participants with lower-limb amputation. Data for this endpoint was only collected and analyzed for the matched cohort of empagliflozin/DPP-4i.
Number of Participants With Acute Kidney Injury Requiring Dialysis From index date until end of follow-up, up to 67 months. Number of participants with acute kidney injury requiring dialysis. Data for this endpoint was only collected and analyzed for the matched cohort of empagliflozin/DPP-4i.
Healthcare Resource Utilization (HCRU): Number of Any Medical Visit From index date until end of follow-up, up to 67 months. HCRU data were collected from seven of the 11 participating countries including Finland, Japan, South Korea, Norway, Spain, Sweden, and Taiwan. Outcomes captured as HCRU include emergency room visits, first inpatient stay, all-cause hospital admissions and outpatient healthcare visits.
HCRU outcomes were investigated for the matched cohort of empagliflozin/DPP-4 only. Due to possibly huge differences in healthcare systems and local practices, HCRU outcomes were presented descriptively by country as per prespecified analysis plan.
For arms with 0 patients analyzed, no data was collected for the specific outcome in this country.
Trial Locations
- Locations (13)
Gifu University
🇯🇵Gifu, Japan
Steno Diabetes Center Copenhagen, Department of Clinical Epidemiology
🇩🇰Gentofte, Denmark
University of Ulm, Institute for Epidemiology and medical biometry
🇩🇪Ulm, Germany
Maccabi Healthcare Services
🇮🇱Tel Aviv, Israel
Oslo University Hospital, Department of Clinical Lipidology
🇳🇴Oslo, Norway
TFS Trial Form Support International AB
🇸🇪Lund, Sweden
Quantify Research AB
🇸🇪Stockholm, Sweden
Instituto de Investigación Sanitaria INCLIVA
🇪🇸Valencia, Spain
Taiwan Society for Pharmacoeconomics and Outcome Research (TaSPOR)
🇨🇳Taipei City, Taiwan
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Leicester Real World Evidence Unit, Leicester general Hospital
🇬🇧Leicester, United Kingdom
Helsinki University Hospital
🇫🇮Helsinki, Finland
Oslo University Hospital, Department of Cardiology
🇳🇴Oslo, Norway