Evaluating Comparative Effectiveness of Empagliflozin in Type 2 Diabetes Population With and Without Chronic Kidney Disease

Boehringer Ingelheim

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Sodium glucose co-transporter-2 inhibitors; Drug: Glucagon-like Peptide-1 Receptor Agonists; Drug: Empagliflozin; Drug: Dipeptidyl Peptidate-4 inhibitors

Study type: Observational

Funder types: Industry

Identifiers

NCT05465317

1245-0228

Details and patient eligibility

About

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.

Enrollment: 30,400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30,400 participants in 1 patient group

Patients with Type 2 Diabetes Mellitus (T2DM)

Treatment:

Drug: Sodium glucose co-transporter-2 inhibitors

Drug: Empagliflozin

Drug: Glucagon-like Peptide-1 Receptor Agonists

Drug: Dipeptidyl Peptidate-4 inhibitors