Comparative Effectiveness of Empagliflozin in the US

NCT03363464 | Active Not Recruiting FDA Drug

• 1 other identifier: 1245.92
• Study Type: observational
• Target: 230,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (6)

• 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

• 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

  i.e., composite of MI, stroke or all-cause mortality

  60 months

• Composite of MI or stroke hospital admission for heart failure

  60 months

• All-cause mortality

  60 months

Secondary Outcomes (12)

• 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

Study Arms (3)

patients with T2DM initiating empagliflozin

Type 2 diabetes mellitus

Drug: Empagliflozin

patients with T2DM initiating a DPP-4 inhibitor

dipeptidyl peptidase-4 inhibitor treated patients

Drug: DPP-4 inhibitor

patients with T2DM initiating a GLP-1 receptor agonist

Glucagon-like peptide-1 receptor agonist treated patients

Drug: GLP-1 receptor agonist

Interventions

Empagliflozin DRUG

Empagliflozin

Also known as: JARDIANCE, JARDIANZ, GIBTULIO

patients with T2DM initiating empagliflozin

DPP-4 inhibitor DRUG

dipeptidyl peptidase-4 inhibitor

patients with T2DM initiating a DPP-4 inhibitor

GLP-1 receptor agonist DRUG

Glucagon-like peptide-1 receptor agonist

patients with T2DM initiating a GLP-1 receptor agonist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

T2DM eligible patients in Medicare fee for service, plans A, B, D; United Healthcare (Optum Clinformatics Data Mart); MarketScan (Truven Healthcare Analytics)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Bringham Women Hospital

Boston, Massachusetts, 02120, United States

Location

Related Publications (1)

• Patorno E, Pawar A, Franklin JM, Najafzadeh M, Deruaz-Luyet A, Brodovicz KG, Sambevski S, Bessette LG, Santiago Ortiz AJ, Kulldorff M, Schneeweiss S. Empagliflozin and the Risk of Heart Failure Hospitalization in Routine Clinical Care. Circulation. 2019 Jun 18;139(25):2822-2830. doi: 10.1161/CIRCULATIONAHA.118.039177. Epub 2019 Apr 8.

  PMID: 30955357 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin; Dipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: December 6, 2017
• Study Start: October 16, 2017
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)