EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) Study Program

Plain English Summary

Comparative Effectiveness of Empagliflozin in the US is a Not Applicable clinical trial sponsored by Boehringer Ingelheim studying Diabetes Mellitus, Type 2. This study examines how well empagliflozin works and its safety in a large group of people with type 2 diabetes in the U.S. It's for adults with type 2 diabetes who are starting empagliflozin or a different type of diabetes medication (DPP-4 inhibitor). Participation involves analyzing existing health records; no new treatments are given as part of this study. Alternatives include other diabetes medications like DPP-4 inhibitors, GLP-1 receptor agonists, and lifestyle changes. The trial aims to enroll 230000 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 18 or older (or 65+ if using Medicare data) and have been diagnosed with type 2 diabetes. You must be starting empagliflozin or a DPP-4 inhibitor and not have used similar medications in the past year. You cannot join if you have type 1 diabetes, secondary diabetes, gestational diabetes, a history of cancer, end-stage kidney disease, HIV, or have had an organ transplant. Individuals in nursing homes or with missing age/sex information will also be excluded. This trial is studying Diabetes Mellitus, Type 2, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure how often patients experience major heart problems (like heart attack or stroke) or need to be hospitalized for heart failure, indicating the drug's potential to protect h The specific primary outcome measures are: 3-point major adverse cardiovascular events (MACE) (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 (60 months); Composite of MI or stroke hospital admission for heart failure (60 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it will show how effective and safe empagliflozin is for a broad range of patients in everyday medical practice, filling a gap in understanding beyond controlled clinical tr This research targets Diabetes Mellitus, Type 2, where improved treatment options are needed.

Investor Insight

This observational study, with a large planned enrollment, signals strong interest from the sponsor in demonstrating empagliflozin's real-world benefits, potentially strengthening its market position The large enrollment target of 230000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if empagliflozin is the right choice for you, considering your specific health needs and other medications. This study uses your existing health data, so your day-to-day routine should not change. Your doctor will continue to manage your diabetes care as usual. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 230,000 participants

Interventions

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

Primary Outcomes

• 3-point major adverse cardiovascular events (MACE) (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 (60 months)
• Composite of MI or stroke hospital admission for heart failure (60 months)

Secondary Outcomes

• 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)

Full Eligibility Criteria

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.

Trial Locations

• Bringham Women Hospital, Boston, Massachusetts, United States

Frequently Asked Questions

Related Conditions

• Diabetes Mellitus, Type 2
• Cardiovascular Disease
• Heart Failure
• Kidney Disease
• Obesity
• Hypertension
• Hyperlipidemia
• Metabolic Syndrome
• End-Stage Renal Disease
• Diabetic Ketoacidosis

More Diabetes Mellitus, Type 2 Trials

View all Diabetes Mellitus, Type 2 clinical trials