Evaluation of Empagliflozin vs Standard Care in Veterans With Prediabetes

Part of paid clinical trials in Asheville, North Carolina.

Sponsor
Charles George VA Medical Center
Study ID
NCT06828731
Phase
PHASE1
Status
Completed

Conditions

  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
35 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10mg daily — DRUG
    This intervention will assess recruitment and retention (feasibility trial).
  • Lifestyle education — OTHER
    This intervention is considered standard care for prediabetes.

Study Details

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.

Key Dates

Start date
Dec 6, 2024
Status verified
Nov 2025
Primary completion
Sep 5, 2025
Completion
Sep 5, 2025

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Recruitment [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Charles George VA Medical CenterAshevilleNorth Carolina28805-

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By research site
Charles George VA Medical Center· Asheville, NC

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