AzTrials
AzTrials

Pre-DiabetesPhase 1Pre-DMNCT06446531

Prevention of Progression of Prediabetes, Obesity and CV Risk

A Phase 1 study testing Rybelsus Tablet, Jardiance 25Mg Tablet and Metformin in people with Pre-Diabetes and Weight, Body, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The investigators are studying how to help people with prediabetes (Pre-DM) and obesity. The goal is to use new and affordable treatments to bring blood sugar levels back to normal and help participants to lose weight. The investigators also want to reduce participants risk of heart problems. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Rybelsus Tablet, Jardiance 25Mg Tablet and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteUnited States
Study dates
11 Sep 2024to Jul 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Age ≥ 18 years old
  • Body Mass Index (BMI)=25-40 kg/m2
  • Glycated Hemoglobin (HbA1c) = 5.7-6.4%
  • Blood Pressure (BP) <160/100
  • Estimated Glomerular Filtration Rate (eGFR) ≥30 ml/min•1.73m2
Show all 16Show fewer
  • Body weight must be stable (±5 pounds) over the last 3 months.
  • 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.
  • Hispanic ethic group
  • Willing to adhere to medication regimen for up to 6 months.
  • Male or female, if female, met these criteria:
  • Not pregnant or breast-feeding
  • Negative pregnancy test result at visit 1 (screening)
  • 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
  • Does not suffer from severe claustrophobia
  • No contraindication for Magnetic Resonance Imaging (MRI) (metal plates, screws, shrapnel, pins, or cardiac pacemaker)

Who cannot join

  • Patients currently on one of the selected therapies
  • Extended diagnoses with Type 2 Diabetes
  • Pregnancy, lactation, women of childbearing age (WOCBA) unwilling to use contraception
  • Known allergy/sensitivity to study drugs or their ingredients
  • Major oncologic diagnosis in the last 5 years
  • Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
Show all 16Show fewer
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent
  • Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study
  • Myocardial infraction, coronary artery bypass graft surgery, or other major cardiovascular event in the past 60 days
  • Heart transplant recipient or listed for a heart transplant
  • Currently implanted left ventricular assist device
  • Cardiomyopathy based on infiltrative or cumulative hypertrophic obstructive cardiomyopathy or known pericardial constriction
  • Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period
  • 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
  • Implanted cardioverter defibrillator within 3 months prior to screening
  • Cardiac resynchronization therapy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Carolina Solis-Herrera, MD contact

210-567-4900

solisherrera@uthscsa.edu

Francisca Acosta, PhD contact

acostafm@uthscsa.edu

United States1 site, 1 recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

    Carolina Solis-Herrera, MD, 210-567-4900, solisherrera@uthscsa.edu

    Recruiting

Other trials in United States

About this study

Official title: Pioneering and Affordable Strategies to Prevent Progression of Prediabetes, Obesity and CV Risk in Hispanics

The investigators are studying how to help people with prediabetes (Pre-DM) and obesity. The goal is to use new and affordable treatments to bring blood sugar levels back to normal and help participants to lose weight. The investigators also want to reduce participants risk of heart problems. The study team will look at how these treatments affect metabolism and other body functions to help find new ways to treat diabetes and obesity in the future.

Read the detailed description

While taking part in this study, participants will be asked to attend approximately 16 visits with the researchers or study staff.

Study participants are assigned (single-blinded, only the study team will know the assigned group) to one of 4 study groups, receiving a 6-month treatment with Nutritional Consultation + either SGLT2 Inhibitor (Empagliflozin), Rybelsus (GLP1 Receptor Agonist), Metformin + Pioglitazone, or placebo. A placebo is an inactive, harmless substance that looks like the other study drugs. This study does not require overnight stays at the hospital in any of the study groups.

Duration of the Study will be about 6-7 months.

Being tested
Placebo, Rybelsus Tablet, Jardiance 25Mg Tablet, Metformin, Actos
Keywords
Affordable strategies, Prevention of progression, Hispanic
Medical subject headings
Glucose Intolerance, Body Weight, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Also called Zebbo

    Oral tablet administered once daily

  • Rybelsus TabletDrug

    Also called Semaglutide

    Oral tablet started at a 3mg dose once daily and increased to 7mg once daily or maximum tolerable dose.

  • Jardiance 25Mg TabletDrug

    Also called Empagliflozin

    Oral 25 mg Sodium-Glucose Co-Transporter (SGLT2) inhibitor administered once daily

  • MetforminDrug

    Also called Metformin Hydrochloride

    Oral tablet started at a dose of 500mg with an increase of 500mg weekly up to a maximum dose of 2000mg (4 tablets)

  • ActosDrug

    Also called Pioglitazone

    Oral tablet dosed at 15mg once daily

Study groups in NCT06446531
Study groupRoleWhat they receive
PlaceboPlacebo comparatorRandomization will occur 1:1:1:1 to this placebo group
Receives: Drug: Placebo
SGLT2 inhibitor GroupExperimentalRandomization will occur 1:1:1:1 to this SGLT2 inhibitor group
Receives: Drug: Jardiance 25Mg Tablet
GLP-1 Receptor Agonist GroupExperimentalRandomization will occur 1:1:1:1 to this GLP-1 receptor agonist group
Receives: Drug: Rybelsus Tablet
Metformin with SGLT2 Inhibitor GroupExperimentalRandomization will occur 1:1:1:1 to this metformin plus SGLT2 inhibitor group
Receives: Drug: Metformin; Drug: Actos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin A1c Level (HBA1c)

    Percentage of glycated hemoglobin level in blood

    Measured: Baseline and 6 months

Secondary outcomes (8)

  1. Body Mass Index (BMI)

    Measure of body fat based on height and weight that applies to adult men and women

    Measured: Baseline and 6 months

  2. Percentage of Body Fat Composition

    Measurement of body fat using a DEXA scan

    Measured: Baseline and 6 months

  3. Left Ventricular Function

    Cardiac function is measured by left-ventricular function measured using cardiac MRI and expressed as a percentage

    Measured: Baseline and 6 months

  4. Measure of phosphocreatine k-value

    A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS

    Measured: Baseline and 6 months

  5. Measure of oxidative capacity

    A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS

    Measured: Baseline and 6 months

  6. Measure of intramyocellular lipids (IMCL)

    A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS

    Measured: Baseline and 6 months

  7. Measure of extramyocellular lipids (EMCL)

    A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS

    Measured: Baseline and 6 months

  8. Patient Reported Outcomes (PROMIS)

    A survey used to assess physical function. Subjects will rank 20 questions from a scale of 1 - 5, with 5 being the highest physical function and 1 being the lowest. The score will be added up, and the Raw score will be converted to T-Score using the PROMIS Adult v2.0 Physical Function 20a Short Form Conversion Table. The range of T-scores is 12.1-62.5. A higher score indicates higher physical function.

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2024
  2. Study start11 Sep 2024
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-blind Randomized, placebo-controlled trial.
Masking
Single blind
Who is masked
Participant
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06446531
Sponsor's protocol ID
STUDY00000485 Pre-DM
Acronym
Pre-DM
Status last verified
Nov 2025
First submitted
31 May 2024
Last updated
12 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Institution or respective designees may present or publish the results of a scientific investigation involving this Study in accordance with International Committee of Medical Journal Editors (ICMJE). The Sponsor Investigator, funding agency, or PI initiating the study will collaborate to determine who has publication rights for authorship upon review and approval of proposed manuscripts.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rybelsus Tablet, Jardiance 25Mg Tablet and Metformin in people with Pre-Diabetes and Weight, Body, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carolina Solis-Herrera, MD (210-567-4900, solisherrera@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin A1c Level (HBA1c) (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06446531.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in