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

Charles George VA Medical Center

Status and phase: Completed; Phase 1

Conditions: Prediabetes

Treatments: Other: Lifestyle education; Drug: Empagliflozin 10mg daily

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06828731

VISN6CDA2024 (Other Identifier)

IRB00001926S01

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 35 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Standard Care

Active Comparator group

Description:

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.

Treatment:

Other: Lifestyle education

Standard Care plus empagliflozin

Experimental group

Description:

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.

Treatment:

Drug: Empagliflozin 10mg daily

Other: Lifestyle education