N/A
N=327,624
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
Bottom Line
View on ClinicalTrials.gov: NCT03817463 ↗Enrolled (actual)
327,624
Serious AEs
—
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition — 1395; 2043; 765; 1083 Participants — p=<0.005
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor (Drug); Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition |
1395; 2043; 765; 1083 | <0.005 sig |
| PRIMARY Number of Participants With Hospitalization for Heart Failure (HHF), Broad Definition |
964; 1260; 514; 641 | <0.005 sig |
| PRIMARY Number of Participants With Hospitalization for Heart Failure (HHF), Specific Definition |
273; 345; 178; 195; 80; 190 | <0.005 sig |
| PRIMARY Number of Participants With All-cause Mortality (ACM) |
1371; 2524; 572; 1177 | <0.005 sig |
| PRIMARY Number of Participants With Composite Outcome, Including Hospitalization for Heart Failure (HHF) and All Cause Mortality (ACM) |
2413; 3749; 1239; 2063 | <0.05 sig |
| PRIMARY Number of Participants With Composite Outcome, Including Myocardial Infraction (MI), Stroke and All Cause Mortality (ACM) |
2548; 3758; 1236; 1950 | <0.005 sig |
| PRIMARY Number of Participants With Myocardial Infarction (MI) |
701; 863; 364; 414 | 0.816 |
| PRIMARY Number of Participants With Stroke |
183; 230; 110; 112; 38; 54 | <0.011 sig |
| SECONDARY Number of Participants With Cardiovascular Mortality (CM) |
67; 161; 35; 107; 44; 73 | <0.005 sig |
| SECONDARY Number of Participants With Composite Outcome Including Hospitalization for Heart Failure (HHF) and Cardiovascular (CV) Mortality |
397; 806; 205; 505 | <0.005 sig |
| 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 |
843; 1009; 393; 516 | 0.545 |
| SECONDARY Number of Participants With Coronary Revascularization Procedure |
173; 184; 117; 109; 26; 19 | 0.353 |
| SECONDARY Number of Participants With End-stage Renal Disease (ESRD) |
65; 116; 34; 56; 14; 43 | <0.005 sig |
| SECONDARY Number of Participants With Estimated Glomerular Filtration Rate (eGFR) Decline |
1569; 1908; 914; 1043 | 0.535 |
| SECONDARY Number of Participants With Progression From Normoalbuminuria to Micro- or Macroalbuminuria |
260; 158; 121; 79; 215; 213 | 0.828 |
| SECONDARY Number of Participants With Composite Outcome Including eGFR Decline and Progression to Micro- or Macroalbuminuria |
2456; 3652; 1324; 1710 | 0.642 |
| SECONDARY Number of Participants With Bone Fracture |
91; 88; 40; 59; 10; 6 | 0.091 |
| SECONDARY Number of Participants With Diabetic Ketoacidosis |
16; 6; 16; 11; 19; 9 | <0.005 sig |
| SECONDARY Number of Participants With Severe Hypoglycemia |
29; 23; 11; 13; 16; 7 | 0.654 |
| SECONDARY Number of Participants With Lower-limb Amputation |
9; 8; 12; 16; 5; 8 | 0.233 |
| SECONDARY Number of Participants With Acute Kidney Injury Requiring Dialysis |
33; 40; 21; 46; 60; 100 | <0.005 sig |
| SECONDARY Healthcare Resource Utilization (HCRU): Number of Any Medical Visit |
1187; 2138; 42; 43; 767; 847 | — |
| SECONDARY Healthcare Resource Utilization (HCRU): Number of Any Prescription |
11243; 11003; 1417; 1639; 32341; 29211 | — |
| SECONDARY Total Healthcare Costs - Finland, Norway, Sweden |
857; 1356; 1058; 1336; 658; 1036 | — |
| SECONDARY Total Healthcare Cost - Japan |
91867; 63773 | — |
| SECONDARY Total Healthcare Cost - South Korea |
214; 220 | — |
| SECONDARY Total Healthcare Cost - Taiwan |
530; 431 | — |
Summary
Non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of Type 2 diabetes mellitus.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03817463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.