Using empagliflozin to manage prediabetes in veterans
Sodium-glucose Transporter 2 Inhibitor Use in Pre-diabetes: Initial Evaluation in Veterans
This study is testing if a diabetes medication called empagliflozin can help veterans with prediabetes avoid getting diabetes and improve their heart and kidney health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 35 Years to 60 Years |
| Sex | All |
| Sponsor | Charles George VA Medical Center Federal |
| Locations | 1 site (Asheville, North Carolina) |
| Trial ID | NCT06828731 on ClinicalTrials.gov |
What this trial studies
This pilot feasibility study evaluates the effectiveness of empagliflozin, a sodium glucose transporter 2 inhibitor, compared to standard care in veterans diagnosed with prediabetes. Over a 12-week period, participants will receive daily doses of empagliflozin along with lifestyle education to assess its impact on preventing the progression to diabetes and reducing cardiovascular and kidney complications. The study aims to gather preliminary data on the safety and feasibility of this treatment approach in a veteran population.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 35 to 60 with a diagnosis of prediabetes.
Not a fit: Patients with a diagnosis of diabetes or contraindications to SGLT2 inhibitors will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option to help veterans with prediabetes avoid developing diabetes and its associated complications.
How similar studies have performed: While the use of SGLT2 inhibitors in diabetes management is well-documented, this specific application in prediabetes among veterans is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: * 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
Where this trial is running
Asheville, North Carolina
- Charles George VA Medical Center — Asheville, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Beth Greck, PharmD
- Email: beth.greck@va.gov
- Phone: (828) 298-7911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.