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Acipimox + Empagliflozin for Heart Failure and Type 2 Diabetes

Phase < 1
Recruiting
Led By Ralph DeFronzo, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-80 years
Type 2 Diabetes Mellitus
Must not have
Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone
Physical disability preventing safe performance of the exercise protocol.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 months

Summary

This trial will look at how a certain type of medication affects people with type 2 diabetes and heart failure. The medication may provide extra fuel for the heart and improve its function. The researchers will measure

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include low blood sugar, dehydration, urinary tract infections from Empagliflozin; flushing and gastrointestinal discomfort from Acipimox; and no expected active side effects from the placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I have Type 2 Diabetes.
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I have moderate to severe heart failure with an ejection fraction below 50%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently taking medication for diabetes that includes SGLT2 inhibitors, GLP-1 receptor agonists, or pioglitazone.
Select...
I have a physical disability that makes it unsafe for me to do certain exercises.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ATPmax production
Change in Adenosine Triphosphate (ATP)
Change in Inorganic Phosphate
+2 more
Secondary study objectives
6-min walking test
Acetoacetate concentrations
Patient-Reported Outcomes Measure Information System
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Empagliflozin GroupExperimental Treatment2 Interventions
Subjects will be randomized 2:1 to receive empagliflozin, 25mg/day for 3 months
Group II: Placebo groupPlacebo Group2 Interventions
Subjects will be randomized to receive the empagliflozin placebo for 3 months

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
476 Previous Clinical Trials
92,904 Total Patients Enrolled
5 Trials studying Heart Failure
234 Patients Enrolled for Heart Failure
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,449 Previous Clinical Trials
4,332,396 Total Patients Enrolled
7 Trials studying Heart Failure
432 Patients Enrolled for Heart Failure
Ralph DeFronzo, MDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio
11 Previous Clinical Trials
959 Total Patients Enrolled
2 Trials studying Heart Failure
108 Patients Enrolled for Heart Failure
~47 spots leftby Nov 2026
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