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Sodium-glucose cotransporter 2 (SGLT2) inhibitor

Empagliflozin for Prediabetes

Phase 4
Recruiting
Led By Sean A Newsom, Ph.D.
Research Sponsored by Oregon State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Medications including glucose lowering medications and supplements (SGLT2 inhibitors, GLP1 agonists, sulfonylurea, insulin, TZDs); mono-amine oxidase inhibitors; beta-blockers; diuretics
Diagnosed type 2 diabetes. In absence of diagnosis, two separate samples with test results of fasting blood glucose ≥126 mg/dL or HbA1c ≥6.5% (48 mmol/mol)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up fasting plasma glucose is measured before the start of the intervention (baseline) and during week 13 of the intervention.
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing whether the drug empagliflozin can help improve regulation of blood sugar in overweight or obese adults with prediabetes. They will also be looking at possible mechanisms to explain how empagliflozin might improve metabolism in skeletal muscle.

Who is the study for?
This trial is for overweight or obese adults with prediabetes, defined by specific blood sugar levels. Participants should have a BMI between 26-45 and stable weight. They can't join if they smoke, are pregnant, take certain medications (like glucose-lowering drugs), have major health issues like heart disease or diabetes, exercise regularly, or have allergies to empagliflozin.
What is being tested?
The study tests whether empagliflozin improves blood sugar regulation in skeletal muscle among those at risk for diabetes. It compares the effects of empagliflozin against a placebo (multivitamin) on how the body and muscles handle glucose.
What are the potential side effects?
Empagliflozin may cause urinary tract infections, genital yeast infections, low blood pressure, ketoacidosis (high acid levels in the blood), sensitivity reactions and might increase the risk of lower limb amputation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking any diabetes, depression, blood pressure, or water pills.
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I have been diagnosed with type 2 diabetes or have high blood sugar levels.
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I do not have major health issues like severe diabetes, heart disease, or liver problems.
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I don't have kidney issues, allergies to empagliflozin, or a history of ketoacidosis, low blood pressure, frequent infections, or amputations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~fasting plasma glucose is measured before the start of the intervention (baseline) and during week 13 of the intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and fasting plasma glucose is measured before the start of the intervention (baseline) and during week 13 of the intervention. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Insulin-stimulated glucose disposal
Secondary study objectives
Fasting plasma glucose concentration
Oral glucose tolerance
Skeletal muscle energetic stress
+4 more

Side effects data

From 2021 Phase 3 trial • 5988 Patients • NCT03057951
15%
Cardiac failure
7%
Hypertension
7%
Hypotension
7%
Urinary tract infection
6%
Renal impairment
6%
Hyperkalaemia
6%
Fall
5%
Atrial fibrillation
5%
Diabetes mellitus
4%
Hyperuricaemia
4%
Anaemia
3%
Acute kidney injury
3%
Pneumonia
2%
COVID-19
2%
Death
2%
Acute myocardial infarction
2%
Cardiac failure congestive
1%
Cardiac failure chronic
1%
Cellulitis
1%
Syncope
1%
Chronic kidney disease
1%
COVID-19 pneumonia
1%
Ischaemic stroke
1%
Coronary artery disease
1%
Basal cell carcinoma
1%
Chronic obstructive pulmonary disease
1%
Myocardial infarction
1%
Sepsis
1%
Transient ischaemic attack
1%
Angina unstable
1%
Cerebrovascular accident
1%
Angina pectoris
1%
Ventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Empagliflozin

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EmpagliflozinExperimental Treatment1 Intervention
Participants will be provided 10-25mg empagliflozin per day for 13 weeks.
Group II: Multivitamin-PlaceboPlacebo Group1 Intervention
Participants will be provided 1 multivitamin-placebo per day for 13 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin
2017
Completed Phase 4
~181750

Find a Location

Who is running the clinical trial?

Oregon State UniversityLead Sponsor
50 Previous Clinical Trials
8,394 Total Patients Enrolled
Samaritan Health ServicesOTHER
4 Previous Clinical Trials
225 Total Patients Enrolled
Sean A Newsom, Ph.D.Principal InvestigatorOregon State University
1 Previous Clinical Trials
9 Total Patients Enrolled

Media Library

Empagliflozin (Sodium-glucose cotransporter 2 (SGLT2) inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05426525 — Phase 4
Prediabetes Research Study Groups: Empagliflozin, Multivitamin-Placebo
Prediabetes Clinical Trial 2023: Empagliflozin Highlights & Side Effects. Trial Name: NCT05426525 — Phase 4
Empagliflozin (Sodium-glucose cotransporter 2 (SGLT2) inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05426525 — Phase 4
Prediabetes Patient Testimony for trial: Trial Name: NCT05426525 — Phase 4
~6 spots leftby Apr 2025
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