PrediabetesPhase 1PREVNTNCT06828731
Evaluation of Empagliflozin vs Standard Care in Veterans With Prediabetes
A Phase 1 study testing Empagliflozin 10mg daily and Lifestyle education in people with Prediabetes, run by Charles George VA Medical Center at 1 site in United States.
Trial summary
Prediabetes effects 96 million people 18 years of age or older. It is important to identify treatment options to slow or prevent progression to diabetes. It is also critical to assess the potential of medications like sodium glucose transporter 2 inhibitors to reduce the risk of cardiovascular events and kidney… Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- Empagliflozin 10mg daily and Lifestyle education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2024to 5 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of prediabetes defined by HbA1c >5.7% and <6.5% or fasting glucose 100-125 mg/dL with documentation of diagnosis (ICD-10 code) within electronic health record at time of enrollment
- Age 35 to 60 years at time of enrollment
- Able to read and speak English
Who cannot join
- Diagnosis of diabetes (type 2 or type 1)
- Contraindication to SGLT2i medication per medication labeling, prior adverse reaction to SGLT2i medication, or received SGLT2i medication within the 6 months prior to enrollment
- Currently prescribed an antihyperglycemic agent approved for treatment of type 2 diabetes or taking any FDA-approved weight loss agent or over-the-counter supplement promoted for weight loss
- Veterans unable to complete informed consent process (Veterans with impaired decision-making ability or who require use of a legally authorized representative)
- Women who are pregnant or may become pregnant
- Veterans with neurogenic bladder, indwelling catheter, or urinary tract infection within the previous 12 months requiring hospitalization or emergency department visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles George VA Medical Center
Asheville, North Carolina, 28805
About this study
Official title: Sodium-glucose Transporter 2 Inhibitor Use in Pre-diabetes: Initial Evaluation in Veterans
Prediabetes effects 96 million people 18 years of age or older. It is important to identify treatment options to slow or prevent progression to diabetes. It is also critical to assess the potential of medications like sodium glucose transporter 2 inhibitors to reduce the risk of cardiovascular events and kidney complications, both common and costly complications of diabetes. This is a 12-week, open-label pilot feasibility study assessing the use of empagliflozin in prediabetes.
- Conditions
- Prediabetes
- Being tested
- Empagliflozin 10mg daily, Lifestyle education
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10mg dailyDrug
This intervention will assess recruitment and retention (feasibility trial).
Lifestyle educationOther
This intervention is considered standard care for prediabetes.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Participants in this arm will receive lifestyle education to manage pre-diabetes as well as the monitoring of HbA1c, kidney function, weight, and blood pressure. Receives: Other: Lifestyle education |
| Standard Care plus empagliflozin | Experimental | Participants in this arm will receive lifestyle education to manage pre-diabetes as well as the monitoring of HbA1c, kidney function, weight, and blood pressure. They will also receive empagliflozin 10mg daily. Receives: Drug: Empagliflozin 10mg daily; Other: Lifestyle education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Number of participants screened during study period Number of participants randomized during study period Number of participants enrolled during study period
Measured: 12 weeks
Retention
Number of participants enrolled who complete the study Number of participants enrolled who do not complete the study and reason for not completing the study
Measured: 12 weeks
Secondary outcomes (5)
HbA1c (%)
HbA1c measured at baseline (visit 1) and 12 weeks (visit 3) will be reported as aggregate data for change from baseline to visit 3 for control group and exposure group.
Measured: 12 weeks
Renal function (ml/min)
estimated GFR (eGFR) (ml/min) will be collected at each study visit and reported as aggregate data for change from baseline to visit 2 and visit 3 for control group and exposure group.
Measured: Every visit (baseline (T), T+2-4 weeks, T+12 weeks)
Weight (kg)
Weight (kg) will be collected at each study visit and reported as aggregate data for change from baseline to visit 2 and visit 3 for control group and exposure group.
Measured: Every visit (baseline (T), T+2-4 weeks, T+12 weeks)
Blood pressure (mmHg)
Average of 2 sitting blood pressure measurements (mmHg) will be collected at each study visit and reported as aggregate data for change from baseline to visit 2 and visit 3 for control group and exposure group.
Measured: Every visit (baseline (T), T+2-4 weeks, T+12 weeks)
Adverse Events
Total number of adverse events occurring among enrolled participants in each group as well as type of adverse event. At conclusion of study will report percent of adverse events reported with each group, i.e. number of participants in control group reporting adverse event/total number of participants enrolled in control group.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start6 Dec 2024
- Primary completion5 Sep 2025
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles George VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Beth Greck, Charles George VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828731
- Sponsor's protocol ID
- IRB00001926S01
- Other IDs
- VISN6CDA2024
- Acronym
- PREVNT
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium-glucose Transporter 2 Inhibitor Use in Pre-diabetes: Initial Evaluation in Veterans
- ClinicalTrials.gov ID
- NCT06828731
- Acronym / sponsor ID
- PREVNT / IRB00001926S01
- Conditions
- Prediabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Charles George VA Medical CenterUS federal agency
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prediabetes effects 96 million people 18 years of age or older. It is important to identify treatment options to slow or prevent progression to diabetes. It is also critical to assess the potential of medications like sodium glucose transporter 2 inhibitors to reduce the risk of cardiovascular events and kidney complications, both common and costly complications of diabetes. This is a 12-week, open-label pilot feasibility study assessing the use of empagliflozin in prediabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Other: Lifestyle educationParticipants in this arm will receive lifestyle education to manage pre-diabetes as well as the monitoring of HbA1c, kidney function, weight, and blood pressure. |
| Standard Care plus empagliflozin | Experimental | Drug: Empagliflozin 10mg daily, Other: Lifestyle educationParticipants in this arm will receive lifestyle education to manage pre-diabetes as well as the monitoring of HbA1c, kidney function, weight, and blood pressure. They will also receive empagliflozin 10mg daily. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of prediabetes defined by HbA1c >5.7% and <6.5% or fasting glucose 100-125 mg/dL with documentation of diagnosis (ICD-10 code) within electronic health record at time of enrollment
- Age 35 to 60 years at time of enrollment
- Able to read and speak English
Key exclusion criteria (6 listed)
- Diagnosis of diabetes (type 2 or type 1)
- Contraindication to SGLT2i medication per medication labeling, prior adverse reaction to SGLT2i medication, or received SGLT2i medication within the 6 months prior to enrollment
- Currently prescribed an antihyperglycemic agent approved for treatment of type 2 diabetes or taking any FDA-approved weight loss agent or over-the-counter supplement promoted for weight loss
- Veterans unable to complete informed consent process (Veterans with impaired decision-making ability or who require use of a legally authorized representative)
- Women who are pregnant or may become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10mg dailyThis intervention will assess recruitment and retention (feasibility trial). | Drug | Standard Care plus empagliflozin |
| Lifestyle educationThis intervention is considered standard care for prediabetes. | Other | Standard Care, Standard Care plus empagliflozin |
Primary outcome
Recruitment
Time frame: 12 weeks
Number of participants screened during study period Number of participants randomized during study period Number of participants enrolled during study period
Retention
Time frame: 12 weeks
Number of participants enrolled who complete the study Number of participants enrolled who do not complete the study and reason for not completing the study
5 secondary outcomes
HbA1c (%)
Time frame: 12 weeks
Renal function (ml/min)
Time frame: Every visit (baseline (T), T+2-4 weeks, T+12 weeks)
Weight (kg)
Time frame: Every visit (baseline (T), T+2-4 weeks, T+12 weeks)
Blood pressure (mmHg)
Time frame: Every visit (baseline (T), T+2-4 weeks, T+12 weeks)
Adverse Events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Empagliflozin 10mg daily and Lifestyle education in people with Prediabetes, run by Charles George VA Medical Center 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 24 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2025.