71 Participants Needed

Acipimox + Empagliflozin for Heart Failure and Type 2 Diabetes

SN
RD
Overseen ByRalph DeFronzo, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: The University of Texas Health Science Center at San Antonio
Must be taking: SGLT2 inhibitors

What You Need to Know Before You Apply

What is the purpose of this trial?

The study team will examine the effects of elevated plasma ketone levels following initiation of SGLT2 inhibitor therapy in high-risk type 2 diabetes mellitus (T2DM) individuals with heart failure (HF) with reduced ejection fraction (HFrEF) providing an energy-rich fuel that is taken up with great avidity by the myocardium, to measure change in Left Ventricle diastolic and systolic function

Will I have to stop taking my current medications?

The trial requires participants to be on a stable dose of guideline-directed medications for heart failure, so you may need to continue your current heart failure medications. However, if you are taking Dipeptidyl Peptidase-4 Inhibitors (DPP4i) or pioglitazone for diabetes, you will need to stop those medications to participate.

Is the combination of Acipimox and Empagliflozin safe for humans?

Empagliflozin (Jardiance) is generally safe for humans, but it can cause some side effects like fluid deficits, a risk of euglycemic diabetic ketoacidosis (a serious condition where the body produces high levels of blood acids called ketones), and mycotic genital infections (fungal infections in the genital area). It has been shown to reduce cardiovascular events and delay kidney disease progression in people with type 2 diabetes, but caution is advised in certain situations, such as acute illness or when insulin is reduced or stopped.12345

How is the drug Acipimox + Empagliflozin unique for treating heart failure and type 2 diabetes?

The combination of Acipimox and Empagliflozin is unique because Empagliflozin, a drug that helps lower blood sugar by causing the body to excrete glucose through urine, is also effective in reducing the risk of hospitalization and cardiovascular death in heart failure patients, even those without diabetes. This dual benefit makes it a novel option for patients with both heart failure and type 2 diabetes.12346

What data supports the effectiveness of the drug empagliflozin for heart failure and type 2 diabetes?

Research shows that empagliflozin (Jardiance) helps reduce the risk of hospitalization and death in people with heart failure, and it also lowers blood sugar levels in people with type 2 diabetes. This makes it effective for managing both heart failure and diabetes.12378

Who Is on the Research Team?

DeFronzo, Ralph A | Profiles

Ralph A DeFronzo, MD

Principal Investigator

University of Texas Health Science Center San Antonio

Are You a Good Fit for This Trial?

This trial is for high-risk individuals with type 2 diabetes and heart failure who have a reduced ability of the heart to pump blood (HFrEF). Participants should not be currently using SGLT2 inhibitors or medications affecting ketone levels.

Inclusion Criteria

BMI 23-38 kg/m2
Stable body weight (±4 pounds) over the last 3 months
Glycated hemoglobin (HbA1c) 5.5-10%
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Exclusion Criteria

I have a physical disability that makes it unsafe for me to do certain exercises.
I am currently taking medication for diabetes that includes SGLT2 inhibitors, GLP-1 receptor agonists, or pioglitazone.
Systolic BP>180mmHg and/or diastolic BP >100mmHg
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive empagliflozin or placebo for 12 weeks to study the effects on plasma ketone levels and heart function

12 weeks
Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Empagliflozin
  • Ketones
Trial Overview The study is testing if Acipimox, Empagliflozin, or a placebo can improve heart function by increasing ketone levels in the blood. The effects on the left ventricle's pumping ability are measured.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Empagliflozin GroupExperimental Treatment2 Interventions
Group II: Placebo groupPlacebo Group2 Interventions

Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Jardiance for:
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Approved in United States as Jardiance for:
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Approved in Canada as Jardiance for:
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Approved in Japan as Jardiance for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Published Research Related to This Trial

In the EMPEROR-Reduced study involving over 3700 participants with chronic heart failure and reduced ejection fraction, empagliflozin significantly reduced the risk of hospitalization for heart failure complications (13.2% vs. 18.3% for placebo) over an average of 16 months.
Empagliflozin also showed a lower incidence of serious kidney problems (1.6% vs. 3.1% for placebo), indicating its potential safety and efficacy in managing heart failure, although it was associated with a higher rate of genital tract infections.
Drug treatment with empagliflozin lowered risk for hospitalization in people with heart failure with reduced ejection fraction: plain language summary of the EMPEROR-Reduced study.Zannad, F., Macari, S.[2023]
Empagliflozin has been shown to improve cardiorenal outcomes and reduce hospitalization risk for heart failure in patients with diabetes, as demonstrated in the EMPA-REG OUTCOME study.
Clinical studies (EMPEROR-Preserved, EMPEROR-Reduced, EMPULSE) indicate that empagliflozin provides significant benefits over traditional heart failure therapies, including reduced mortality and hospitalizations, and improved quality of life for patients with various heart failure phenotypes.
CLINICAL EFFECTIVENESS OF EMPAGLIFLOZIN IN PATIENTS WITH HEART FAILURE.Rоsul, ММ., Bletskan, ММ., Ivano, NV., et al.[2023]
Empagliflozin (EMPA) significantly reduced the induction of ventricular fibrillation (VF) in an ex-vivo model of ischemia-reperfusion, with only 16.7% of EMPA-treated hearts experiencing VF compared to 60% in control hearts.
EMPA improved cardiac contractility, as shown by a higher left ventricular developed pressure (LVDP) and enhanced calcium cycling, indicating its potential to protect heart function during ischemic events through mechanisms that do not involve sodium-glucose co-transporter-2 (SGLT2).
Anti-arrhythmic and inotropic effects of empagliflozin following myocardial ischemia.Azam, MA., Chakraborty, P., Si, D., et al.[2021]

Citations

Drug treatment with empagliflozin lowered risk for hospitalization in people with heart failure with reduced ejection fraction: plain language summary of the EMPEROR-Reduced study. [2023]
CLINICAL EFFECTIVENESS OF EMPAGLIFLOZIN IN PATIENTS WITH HEART FAILURE. [2023]
Anti-arrhythmic and inotropic effects of empagliflozin following myocardial ischemia. [2021]
A Case of Severe Metabolic Acidosis due to Jardiance-Induced Euglycemic Diabetic Ketoacidosis. [2021]
Diabetes Drug Now Approved for Heart Failure. [2023]
[EMPAGLIFLOZIN (JARDIANCE) :Nw SGLT2 COTRANSPORTER INHIBITOR FOR TREATING TYPE 2 DIABETES]. [2022]
SGLT2 inhibitors: new reports. [2019]
Safety and Efficacy of Empagliflozin as Add-On Therapy to GLP-1 Receptor Agonist (Liraglutide) in Japanese Patients with Type 2 Diabetes Mellitus: A Randomised, Double-Blind, Parallel-Group Phase 4 Study. [2020]
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