Loading clinical trials...

Evaluating Comparative Effectiveness of Empagliflozin in Type 2 Diabetes Population With and Without Chronic Kidney Disease | Clinical Trials | Clareo Health

COMPLETED

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

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

NCT05465317•Boehringer Ingelheim

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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

Locations (1)

Duke Clinical Research Institute

Durham, North Carolina, United States

Key Dates

Start Date

August 8, 2022

Primary Completion Date

May 2, 2023

Completion Date

May 2, 2023

Last Updated

September 19, 2024

Enrollment

62,197

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

Empagliflozin

DRUG

Dipeptidyl Peptidate-4 inhibitors

DRUG

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

NCT06959901

Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

View study

RECRUITINGNA

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

NCT06574035

Diabetes Mellitus, Type 2Depressive Symptoms+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes

Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use

Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)