Comparative Effectiveness of Empagliflozin in the US

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Empagliflozin; Drug: DPP-4 inhibitor; Drug: GLP-1 receptor agonist

• Registration Number: NCT03363464
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with several previous cardiovascular outcomes trials, which failed to demonstrate an association with a higher or a lower risk of cardiovascular outcomes associated with members of other recently marketed antidiabetic classes, the EMPA-REG OUTCOME trial has shown that patients at high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a reduced risk of hospitalization for heart failure, cardiovascular mortality, and all-cause mortality.

However, these and other findings arising from an extensive clinical trial program aimed at evaluating the efficacy and safety profile for empagliflozin have yet to be demonstrated in a non-trial environment. This study aims to investigate the transferability of the effects demonstrated in dedicated randomized clinical studies to a broader population under real world conditions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-05
• Study Start: 2017-10-16
• Study First Submitted QC: 2017-11-30
• Study First Posted: 2017-12-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-12
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 230000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with T2DM initiating empagliflozin	Empagliflozin	Type 2 diabetes mellitus
patients with T2DM initiating a DPP-4 inhibitor	DPP-4 inhibitor	dipeptidyl peptidase-4 inhibitor treated patients
patients with T2DM initiating a GLP-1 receptor agonist	GLP-1 receptor agonist	Glucagon-like peptide-1 receptor agonist treated patients

Primary Outcome Measures

Name	Time	Method
3-point major adverse cardiovascular events (MACE)	60 months	i.e., non-fatal myocardial infarction (MI), non-fatal stroke, or cardiovascular (CV) mortality; as well as each individual component: * Hospital admission for MI (for purposes of this individual component, fatal MI is included); * Hospital admission for stroke (for purposes of this individual component, fatal stroke is included); * CV mortality
Hospitalization for heart failure (specific, based on primary inpatient diagnosis code)	60 months
Hospitalization for heart failure (broad, based on any inpatient diagnosis code)	60 months
Modified MACE	60 months	i.e., composite of MI, stroke or all-cause mortality
Composite of MI or stroke hospital admission for heart failure	60 months
All-cause mortality	60 months

Secondary Outcome Measures

Name	Time	Method
Coronary revascularization procedure	60 months
Hospitalization for unstable angina	60 months
Composite of MI, stroke, unstable angina hospitalization or coronary revascularization	60 months
End-stage renal disease (ESRD)	60 months
Bone fracture	60 months
Diabetic ketoacidosis (Inpatient, primary position)	60 months
Diabetic ketoacidosis (Inpatient, any position)	60 months
Severe hypoglycemia	60 months
Urinary tract cancers	60 months
Acute kidney injury (Inpatient, primary)	60 months
Acute kidney injury (Inpatient, any position)	60 months
Lower-limb amputation	60 months

Trial Locations

Locations (1)

Bringham Women Hospital; 🇺🇸 Boston, Massachusetts, United States