Evaluation of Empagliflozin vs Standard Care in Veterans With Prediabetes (NCT06828731) | Clinical Trial Compass
CompletedPhase 1
Evaluation of Empagliflozin vs Standard Care in Veterans With Prediabetes
United States60 participantsStarted 2024-12-06
Plain-language 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 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.
Who can participate
Age range
35 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.