Evaluation of Empagliflozin vs Standard Care in Veterans With Prediabetes

NCT06828731 | Completed Phase 1 FDA Drug

• 2 other identifiers: IRB00001926S01VISN6CDA2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prediabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• HbA1c (%)

  12 weeks

• Renal function (ml/min)

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

• Weight (kg)

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

• Blood pressure (mmHg)

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

• Adverse Events

  12 weeks

Study Arms (2)

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.

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.

Drug: Empagliflozin 10mg daily; Other: Lifestyle education

Interventions

Empagliflozin 10mg daily DRUG

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

Standard Care plus empagliflozin

Lifestyle education OTHER

This intervention is considered standard care for prediabetes.

Standard Care; Standard Care plus empagliflozin

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles George VA Medical Center: lead

Study Sites (1)

Charles George VA Medical Center

Asheville, North Carolina, 28805, United States

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: February 14, 2025
• Study Start: December 6, 2024
• Primary Completion: September 5, 2025
• Study Completion: September 5, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)