Comparative Effectiveness of Empagliflozin in the US

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) Study Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03363464
• Other study ID #: 1245.92
• Status: Active, not recruiting
• Start date: October 16, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 230000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients >= 18 years old for Marketscan and Optum, and >=65 years old for Medicare only

• Patients initiating empagliflozin or a DPP-4 inhibitor within the study period. Initiation was defined as no use of SGLT-2 inhibitors (canagliflozin, dapagliflozin, ertugliflozin) or DPP-4 inhibitors in the previous 12 months.

• Restriction to patients with a diagnosis of T2DM (ICD-9 Dx code of 250.x0 or 250.x2; ICD-10 Dx code of E11.x) in the 12 months prior to drug initiation.

Exclusion criteria:

• Patients with missing or ambiguous age or sex information.

• All patients who have less than 12 months of continuous registration in the database prior to initiation of empagliflozin or a DPP-4 inhibitor will be excluded.

• Patients with type 1 diabetes mellitus (T1DM) defined as at least 1 inpatient or outpatient codes in the 12 months prior to drug initiation.

• Secondary diabetes, and gestational diabetes in the 12 months prior to drug initiation

• History of cancer in the 5 years prior to drug initiation

• End-stage renal disease (ESRD) in the 12 months prior to drug initiation

• HIV diagnosis or treatment in the 12 months prior to drug initiation

• Organ transplant in the 12 months prior to drug initiation

• Patients that were in nursing homes in the 12 months prior to drug initiation

• Patients with concomitant SGLT-2 inhibitor and DPP-4 inhibitor initiation will also be excluded.

• Patients initiating more than one DPP-4i on cohort entry date will additionally be excluded Additional exclusion criteria apply.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Empagliflozin
Empagliflozin
• DPP-4 inhibitor
dipeptidyl peptidase-4 inhibitor
• GLP-1 receptor agonist
Glucagon-like peptide-1 receptor agonist

Locations

Country	Name	City	State
United States	Bringham Women Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-point major adverse cardiovascular events (MACE)	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	60 months
Primary	Hospitalization for heart failure (specific, based on primary inpatient diagnosis code)		60 months
Primary	Hospitalization for heart failure (broad, based on any inpatient diagnosis code)		60 months
Primary	Modified MACE	i.e., composite of MI, stroke or all-cause mortality	60 months
Primary	Composite of MI or stroke hospital admission for heart failure		60 months
Primary	All-cause mortality		60 months
Secondary	Coronary revascularization procedure		60 months
Secondary	Hospitalization for unstable angina		60 months
Secondary	Composite of MI, stroke, unstable angina hospitalization or coronary revascularization		60 months
Secondary	End-stage renal disease (ESRD)		60 months
Secondary	Bone fracture		60 months
Secondary	Diabetic ketoacidosis (Inpatient, primary position)		60 months
Secondary	Diabetic ketoacidosis (Inpatient, any position)		60 months
Secondary	Severe hypoglycemia		60 months
Secondary	Urinary tract cancers		60 months
Secondary	Lower-limb amputation		60 months
Secondary	Acute kidney injury (Inpatient, primary)		60 months
Secondary	Acute kidney injury (Inpatient, any position)		60 months

External Links

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