Comparative cardiovascular and renal effectiveness and safety of Empagliflozin and other SGLT2i in patients with type 2 diabetes (T2D), with and without baseline kidney disease in the United States

Study identification

• EU PAS number:
  EUPAS45682
• Study ID:
  50338
• Official title and acronym:
  Comparative cardiovascular and renal effectiveness and safety of Empagliflozin and other SGLT2i in patients with type 2 diabetes (T2D), with and without baseline kidney disease in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  While clear renal and cardiovascular benefits of empagliflozin have been demonstrated in randomized clinical trials, the effectiveness of this therapy in direct comparison to other anti-hyperglycemic therapies has not been shown among patients with diabetic kidney disease. We aim to use PCORnet, which is a large, national network of electronic health record data, to determine the following in a real-world population: 1. Characteristics of patients with T2D, both with and without DKD, who have been initiated on empagliflozin vs. those who have been initiated on dipeptidyl peptidate-4 inhibitor (DPP4i) or glucagon-like peptide-1 receptor agonists (GLP1RA) 2. Renal and CV effectiveness of empagliflozin compared with DPP4i and GLP1RA in these same populations, evaluated up to 24 months after treatment initiation. 3. Safety of empagliflozin compared with DPP4i and GLP1RA in these same populations, evaluated up to 24 months after treatment initiation. This is a non-interventional study using existing data from 20 US health systems participating in PCORnet. The study period will be Jan 2014 Dec 2021. The primary comparisons will be incident prescription of empagliflozin or any SGLT2 inhibitor without prior use of any sodium-glucose cotransporter-2 inhibitors or (SGLT2i) or DPP4i compared to incident prescription of any DPP4i without prior use of any DPP4i or any SGLT2i. If feasible based on patient numbers, comparisons between empagliflozin/any SGLT2i and GLP-1 RAs will also be made. The primary outcome will be a composite renal outcome including 40% decline in glomerular filtration rate, incident end stage renal disease, or all-cause mortality (ACM). Secondary outcome is a composite of hospitalization for heart failure and ACM. The primary analysis will be performed using overlap weighting to balance covariates across the two treatment arms (empagliflozin vs DPP4i) and Cox proportional hazards modelling to determine the effect of drug on outcomes.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Duke Clinical Research Institute (DCRI)

Study timelines

Date when funding contract was signed

Actual:08/04/2021

Study start date

Planned:13/08/2022

Actual:08/09/2022

Data analysis start date

Planned:22/08/2022

Date of interim report, if expected

Planned:30/09/2022

Date of final study report

Planned:31/03/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable