Cheap pills could stop prediabetes in its tracks, new study hopes
NCT ID NCT06446531
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests several affordable oral medications—including semaglutide, empagliflozin, metformin, and pioglitazone—to see if they can reverse prediabetes, promote weight loss, and lower heart disease risk in Hispanic adults. Researchers will monitor blood sugar, body fat, and heart function over time. The goal is to find cost-effective treatments that prevent progression to full-blown diabetes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Semaglutide, Empagliflozin, Metformin, Pioglitazone
- What this could lead to
- If successful, this could point toward affordable drug combinations that help people with prediabetes return to normal blood sugar and lose weight, reducing their risk of diabetes and heart disease.
- What could go wrong
- This is a very early Phase 1 trial with only 64 participants, so results may not apply to everyone. The drugs can cause side effects like nausea, diarrhea, or low blood sugar, and it's unknown if the benefits will last long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients will have an established diagnosis of pre-Diabetes Mellitus (DM) before the screening visit, documented by an acceptable modality in the last 6 months. 2. Age ≥ 18 years old 3. Body Mass Index (BMI)=25-40 kg/m2 4. Glycated Hemoglobin (HbA1c) = 5.7-6.4% 5. Blood Pressure (BP) \<160/100 6. Estimated Glomerular Filtration Rate (eGFR) ≥30 ml/min•1.73m2 7. Body weight must be stable (±5 pounds) over the last 3 months. 8. Oral diuretics, if prescribed to the patient according to local guidelines and discretion of the investigator, should be stable for at least 1 week prior to randomization. 9. Hispanic ethic group 10. Willing to adhere to medication regimen for up to 6 months. 11. Male or female, if female, met these criteria: 1. Not pregnant or breast-feeding 2. Negative pregnancy test result at visit 1 (screening) 3. During the entire study, women of childbearing potential (WOCBP) including peri-menopausal women who have a menstrual period within 1 year must practice appropriate, and effective birth control, either implants or pills, or a vasectomized partner prior to receiving the first dose of study medication 12. Does not suffer from severe claustrophobia 13. No contraindication for Magnetic Resonance Imaging (MRI) (metal plates, screws, shrapnel, pins, or cardiac pacemaker) Exclusion Criteria: 1. Patients currently on one of the selected therapies 2. Extended diagnoses with Type 2 Diabetes 3. Pregnancy, lactation, women of childbearing age (WOCBA) unwilling to use contraception 4. Known allergy/sensitivity to study drugs or their ingredients 5. Major oncologic diagnosis in the last 5 years 6. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements 7. Inability or unwillingness of individual or legal guardian/representative to give written informed consent 8. Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study 9. Myocardial infraction, coronary artery bypass graft surgery, or other major cardiovascular event in the past 60 days 10. Heart transplant recipient or listed for a heart transplant 11. Currently implanted left ventricular assist device 12. Cardiomyopathy based on infiltrative or cumulative hypertrophic obstructive cardiomyopathy or known pericardial constriction 13. Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period 14. Acute decompensated heart failure requiring intravenous diuretics, vasodilators, inotropic agents, or mechanical support within 1 week of screening and during the screening period prior to randomization 15. Implanted cardioverter defibrillator within 3 months prior to screening 16. Cardiac resynchronization therapy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Texas Health Science Center at San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
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