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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
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
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ fasting plasma glucose is measured before the start of the intervention (baseline) and during week 13 of the intervention.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insulin-stimulated glucose disposal
Secondary outcome measures
Fasting plasma glucose concentration
Oral glucose tolerance
Skeletal muscle energetic stress
+4 moreSide effects data
From 2021 Phase 3 trial • 5988 Patients • NCT0305795115%
Cardiac failure
7%
Hypertension
7%
Urinary tract infection
7%
Hypotension
6%
Hyperkalaemia
6%
Fall
6%
Renal impairment
5%
Atrial fibrillation
5%
Diabetes mellitus
4%
Anaemia
4%
Hyperuricaemia
3%
Acute kidney injury
3%
Pneumonia
2%
Acute myocardial infarction
2%
COVID-19
2%
Cardiac failure congestive
2%
Death
1%
Myocardial infarction
1%
Cardiac failure chronic
1%
Angina pectoris
1%
Angina unstable
1%
Ventricular tachycardia
1%
COVID-19 pneumonia
1%
Cellulitis
1%
Sepsis
1%
Chronic kidney disease
1%
Coronary artery disease
1%
Chronic obstructive pulmonary disease
1%
Basal cell carcinoma
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Syncope
1%
Transient ischaemic attack
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Empagliflozin
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
49 Previous Clinical Trials
8,341 Total Patients Enrolled
Samaritan Health ServicesOTHER
3 Previous Clinical Trials
180 Total Patients Enrolled
Sean A Newsom, Ph.D.Principal InvestigatorOregon State University
1 Previous Clinical Trials
9 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently smoking or using nicotine, or have quit for less than a year.You are allergic to lidocaine.You have a body mass index (BMI) between 26 and 45.I am not taking any diabetes, depression, blood pressure, or water pills.I have been diagnosed with type 2 diabetes or have high blood sugar levels.I do not have major health issues like severe diabetes, heart disease, or liver problems.You do regular moderate to intense exercise for at least 30 minutes on at least 2 days per week.Your blood sugar levels are within a certain range when you haven't eaten for a while, or your HbA1c levels are within a specific range.I don't have kidney issues, allergies to empagliflozin, or a history of ketoacidosis, low blood pressure, frequent infections, or amputations.Your weight has not changed by more than 10 pounds in the past 3 months.You have slightly high blood sugar levels, but not high enough to be considered diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Empagliflozin
- Group 2: Multivitamin-Placebo
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Prediabetes Patient Testimony for trial: Trial Name: NCT05426525 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for me to become a participant in this trial?
"This clinical trial is looking to accept 40 individuals with prediabetes, aged between 18 and 55."
Answered by AI
Are elderly adults over the age of 70 qualified to partake in this investigation?
"This clinical trial has set the minimum age for enrollment to 18 and imposed a cap of 55 on its upper limit."
Answered by AI
Has the Empagliflozin drug been validated by the Food and Drug Administration?
"There is ample evidence that empagliflozin has been approved for use, thus it earned a score of 3 on the Power scale."
Answered by AI
Is it possible to partake in this investigation at this time?
"Yes, the information accessible on clinicaltrials.gov verifies that this experiment is presently searching for participants. It was initially published on July 1st, 2022 and last modified on July 19th, 2022. This trial needs 40 people from a single medical centre to take part in it."
Answered by AI
To what extent is the current trial being utilized by participants?
"Affirmative. Clinicaltrials.gov holds records that show this clinical trial is actively recruiting participants, with the first posting on July 1st 2022 and most recent update occurring on July 19th 2022. 40 patients are needed at a single medical centre to complete this study."
Answered by AI
Who else is applying?
What state do they live in?
Washington
What site did they apply to?
Oregon State University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I cannot take metformin. I would like to try this new drug. I also like doing clinical studies.
PatientReceived no prior treatments
I have tried Ozempic and Mounjaro and the side effects were too severe to continue. I have tried hypnosis also.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
I would travel by Amtrak to your location. Is there an Uber/Lyft option to get from the train station to your facility?
PatientReceived no prior treatments
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