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Completed

NCT Number: NCT03817463

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

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

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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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Steno Diabetes Center Copenhagen, Department of Clinical Epidemiology, Gentofte Municipality, Denmark

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor

Drug

Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor

Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor

Drug

Dipeptidyl peptidase-4 (DPP-4) inhibitor

Primary outcomes

  1. Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition

    Time frame: 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.

  2. Number of Participants With Hospitalization for Heart Failure (HHF), Broad Definition

    Time frame: 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).

  3. Number of Participants With Hospitalization for Heart Failure (HHF), Specific Definition

    Time frame: 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.

  4. Number of Participants With All-cause Mortality (ACM)

    Time frame: 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).

  5. Number of Participants With Composite Outcome, Including Hospitalization for Heart Failure (HHF) and All Cause Mortality (ACM)

    Time frame: 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).

  6. Number of Participants With Composite Outcome, Including Myocardial Infraction (MI), Stroke and All Cause Mortality (ACM)

    Time frame: 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).

  7. Number of Participants With Myocardial Infarction (MI)

    Time frame: 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).

  8. Number of Participants With Stroke

    Time frame: 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 outcomes

  1. Number of Participants With Cardiovascular Mortality (CM)

    Time frame: 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).

  2. Number of Participants With Composite Outcome Including Hospitalization for Heart Failure (HHF) and Cardiovascular (CV) Mortality

    Time frame: 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.

  3. 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

    Time frame: 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.

  4. Number of Participants With Coronary Revascularization Procedure

    Time frame: 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.

  5. Number of Participants With End-stage Renal Disease (ESRD)

    Time frame: 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).

  6. Number of Participants With Estimated Glomerular Filtration Rate (eGFR) Decline

    Time frame: 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.

  7. Number of Participants With Progression From Normoalbuminuria to Micro- or Macroalbuminuria

    Time frame: 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.

  8. Number of Participants With Composite Outcome Including eGFR Decline and Progression to Micro- or Macroalbuminuria

    Time frame: 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.

  9. Number of Participants With Bone Fracture

    Time frame: 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.

  10. Number of Participants With Diabetic Ketoacidosis

    Time frame: 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

  11. Number of Participants With Severe Hypoglycemia

    Time frame: 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.

  12. Number of Participants With Lower-limb Amputation

    Time frame: 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.

  13. Number of Participants With Acute Kidney Injury Requiring Dialysis

    Time frame: 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.

  14. Healthcare Resource Utilization (HCRU): Number of Any Medical Visit

    Time frame: 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.

  15. Healthcare Resource Utilization (HCRU): Number of Any Prescription

    Time frame: 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.

  16. Total Healthcare Costs - Finland, Norway, Sweden

    Time frame: 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.

  17. Total Healthcare Cost - Japan

    Time frame: 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.

  18. Total Healthcare Cost - South Korea

    Time frame: 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.

  19. Total Healthcare Cost - Taiwan

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2019
Registry last updated
Sep 23, 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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