Evaluation of Empagliflozin vs Standard Care in Veterans With Prediabetes (PREVNT)

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.

Study Overview

• Status: Completed
• Conditions: Prediabetes
• Intervention / Treatment: Other: Lifestyle education; Drug: Empagliflozin 10mg daily

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Asheville, North Carolina, United States, 28805
      • Charles George VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care; 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.	Other: Lifestyle education; This intervention is considered standard care for prediabetes.
Experimental: Standard Care plus empagliflozin; 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.	Other: Lifestyle education; This intervention is considered standard care for prediabetes.; Drug: Empagliflozin 10mg daily; This intervention will assess recruitment and retention (feasibility trial).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Number of participants screened during study period Number of participants randomized during study period Number of participants enrolled during study period	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	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
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.	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.	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.	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.	Every visit (baseline (T), T+2-4 weeks, T+12 weeks)

Collaborators and Investigators

• Sponsor: Charles George VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2024
• Primary Completion (Actual): September 5, 2025
• Study Completion (Actual): September 5, 2025

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Prediabetic State; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; empagliflozin
• Other Study ID Numbers: IRB00001926S01; VISN6CDA2024 (Other Identifier: Veterans Integrated Service Network 6 (Mid-Atlantic) Career Development Award)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No