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OpenTrials
Completed

NCT Number: NCT06828731

Evaluation of Empagliflozin vs Standard Care in Veterans With Prediabetes

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charles George VA Medical Center

Asheville, North Carolina, 28805, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin 10mg daily

Drug

This intervention will assess recruitment and retention (feasibility trial).

Lifestyle education

Other

This intervention is considered standard care for prediabetes.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. HbA1c (%)

    Time frame: 12 weeks

    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.

  2. Renal function (ml/min)

    Time frame: Every visit (baseline (T), T+2-4 weeks, T+12 weeks)

    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.

  3. Weight (kg)

    Time frame: Every visit (baseline (T), T+2-4 weeks, T+12 weeks)

    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.

  4. Blood pressure (mmHg)

    Time frame: Every visit (baseline (T), T+2-4 weeks, T+12 weeks)

    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.

  5. Adverse Events

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Charles George VA Medical Center

Fed

Registry information

Official study title

Sodium-glucose Transporter 2 Inhibitor Use in Pre-diabetes: Initial Evaluation in Veterans

Acronym: PREVNT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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