Evaluation of Empagliflozin vs Standard Care in Veterans With Prediabetes

NCT ID: NCT06828731

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-06
• Study Completion Date: 2025-09-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Lifestyle education

Intervention Type: OTHER

This intervention is considered standard care for prediabetes.

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.

Group Type: EXPERIMENTAL

Empagliflozin 10mg daily

Intervention Type: DRUG

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

Lifestyle education

Intervention Type: OTHER

This intervention is considered standard care for prediabetes.

Interventions

Empagliflozin 10mg daily

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

Intervention Type: DRUG

Lifestyle education

This intervention is considered standard care for prediabetes.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles George VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Beth Greck

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charles George VA Medical Center

Asheville, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

VISN6CDA2024

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00001926S01

Identifier Type: -

Identifier Source: org_study_id