N/A
N=62,197
Evaluating Comparative Effectiveness of Empagliflozin in Type 2 Diabetes Population With and Without Chronic Kidney Disease
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT05465317 ↗Enrolled (actual)
62,197
Serious AEs
—
Results posted
Sep 2024
Primary outcome: Primary: Incidence Rate of the Composite Outcome Including 40% Decline in Estimated Glomerular Filtration Rate (eGFR), Incident End-stage Renal Disease (ESRD) and All-cause Death — 26.65; 36.65; 44.15; 67.36 (First) events per 1000 patient years — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Empagliflozin (Drug); Dipeptidyl Peptidate-4 inhibitors (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of the Composite Outcome Including 40% Decline in Estimated Glomerular Filtration Rate (eGFR), Incident End-stage Renal Disease (ESRD) and All-cause Death |
26.65; 36.65; 44.15; 67.36; 22.62; 29.33 | <0.001 sig |
| SECONDARY Incidence Rate of the 40% Decline in Estimated Glomerular Filtration Rate (eGFR) |
12.10; 16.55; 16.46; 27.39; 11.10; 13.95 | 0.005 sig |
| SECONDARY Incidence Rate of End-stage Kidney Disease (ESKD) |
3.34; 4.90; 8.18; 12.96; 2.23; 2.97 | 0.05 |
| SECONDARY Incidence Rate of Dialysis |
3.47; 4.76; 7.86; 12.03; 2.46; 3.01 | 0.11 |
| SECONDARY Incidence Rate of Kidney Transplant |
0.02; 0.06; 0.10; 0.10; 0.00; 0.05 | — |
| SECONDARY Incidence Rate of Composite Outcome Including Acute Hospitalization for Heart Failure and All-cause Death |
24.65; 30.24; 50.05; 61.34; 18.86; 22.83 | 0.02 sig |
| SECONDARY Incidence Rate of Acute Hospitalization for Heart Failure |
12.74; 14.40; 29.47; 33.08; 8.92; 9.95 | 0.32 |
| SECONDARY Incidence Rate of All-cause Death |
13.47; 18.60; 23.75; 35.56; 11.09; 14.49 | 0.005 sig |
| SECONDARY Incidence Rate of the Composite Outcome Including MI, Stroke, All-cause Death and Coronary Revascularization Procedure |
97.31; 96.36; 169.32; 164.13; 81.63; 80.89 | 0.46 |
| SECONDARY Incidence Rate of the Composite Outcome Including MI, Stroke, All-cause Death (MACE) |
23.93; 30.27; 40.65; 55.67; 20.07; 24.18 | 0.007 sig |
| SECONDARY Incidence Rate of Diabetic Ketoacidosis |
4.06; 2.86; 3.59; 3.46; 4.17; 2.71 | 0.15 |
| SECONDARY Incidence Rate of Severe Hypoglycemia |
9.43; 10.69; 14.90; 18.89; 8.17; 8.72 | 0.43 |
| SECONDARY Incidence Rate of Urinary Tract Cancer |
4.65; 5.14; 8.62; 9.35; 3.74; 4.13 | 0.69 |
| SECONDARY Incidence Rate of Severe Urinary Tract Infections (UTI) |
0.69; 1.01; 0.90; 2.00; 0.64; 0.77 | 0.39 |
| SECONDARY Incidence Rate of Acute Kidney Injury (AKI) That Requires Dialysis |
1.23; 1.45; 2.53; 4.02; 0.93; 0.83 | 0.62 |
| SECONDARY Incidence Rate of Genital Mycotic Infection |
115.96; 65.32; 99.20; 52.23; 119.94; 68.52 | <0.001 sig |
Summary
The primary purpose of this research study is to determine the cardiovascular and renal effectiveness and safety of empagliflozin compared to dipeptidyl peptidase-4 inhibitors (DPP4i) in patients with Type 2 Diabetes Mellitus (T2DM) with and without established kidney disease.
The secondary purpose of this research study is to determine the cardiovascular and renal effectiveness and safety of any Sodium glucose co-transporter-2 inhibitors (SGLT2i) compared to Glucagon-like Peptide-1 Receptor Agonists (GLP1RA) in patients with T2DM.
Eligibility Criteria
Inclusion criteria
- Patients ≥18 years old
- Having a diagnosis of type 2 diabetes in 12 months before the index date (defined as the date of initiation of empagliflozin or Glucagon-like Peptide-1 Receptor Agonists (GLP1RA) or Dipeptidyl Peptidate-4 inhibitor (DPP4i), based on the cohort evaluated), based on International Classification of Diseases (ICD)-9 and -10 codes and other available data
- Record of prescription for empagliflozin, any Sodium glucose co-transporter-2 inhibitors (SGLT2i), any DPP4 inhibitor, or any GLP1RA use between 1 January 2015 and 31 December 2020, and
- No record of any prescription for the drugs being compared during the 12 months + 30-day grace preceding the index date period, i.e.,
- For the primary comparison of initiation of empagliflozin versus DPP4i, patients will not have any prescription for empagliflozin/any SGLT2i or DPP4i during the preceding 12 months + 30-day grace period.
- For the comparison of initiation of SGLT2i versus GLP1RA, patients will not have any prescription for SGLT2i or GLP1RA during the preceding 12 months + 30-day grace period.
- For the comparison of initiation of empagliflozin versus GLP1RA, patients will not have any prescription for empagliflozin/any SGLT2i or GLP1RA during the preceding 12 months + 30-day grace period.
Exclusion criteria
- Aged <18 years on the first prescription date of the qualifying prescription,
- Pre-existing diagnosis of type 1 diabetes mellitus (T1DM) during the 12 months before the index date,
- Having a disqualifying diagnosis during the 12 months before the index date, defined as having at least one of the following: estimated glomerular filtration rate (eGFR) <30, dialysis, polycystic kidney disease or a kidney transplant,
- <12 months of available data before the index date, and/or no complete history of drug dispensations/other records of drug use during this period, defined as not having at least 1 ambulatory visit and at least 1 medication prescription during the preceding 12 months, and
- Missing or ambiguous data on serum creatinine in the 12 months prior to the index date or sex
Data sourced from ClinicalTrials.gov (NCT05465317). 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.