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SGLT2 Inhibitor
Empagliflozin for Type 2 Diabetes
Phase < 1
Recruiting
Led By Ralph DeFronzo, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients treated with diet, sulfonylurea (SU), metformin (MET), or SU/MET
Ages 30-75 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 300 minutes
Awards & highlights
Study Summary
This trial tests a diabetes drug's effect on glucose and fat metabolism, and norepinephrine levels in people with type 2 diabetes.
Who is the study for?
This trial is for adults aged 30-75 with Type 1 or Type 2 diabetes, a BMI of 21-45, and good kidney function (eGFR >60). Participants should be in good health, not on heavy exercise programs, and have stable weight. They can be treated with diet or certain diabetes medications but not insulin or drugs affecting glucose metabolism. Women must use contraception if able to bear children.Check my eligibility
What is being tested?
The study tests the effects of Empagliflozin—a drug that helps control blood sugar—on various metabolic processes in diabetics. Some participants will receive the actual medication while others will get a placebo for comparison. The study also looks at how this drug affects fat breakdown and stress hormone levels.See study design
What are the potential side effects?
Empagliflozin may cause dehydration, urinary tract infections, yeast infections in women, low blood pressure, higher cholesterol levels, joint pain and an increased risk of diabetic ketoacidosis where the body produces excess blood acids (ketones).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am being treated with diet, sulfonylurea, metformin, or both.
Select...
I am between 30 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 300 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 300 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Endogenous Glucose Production (EGP) during Study 1
Endogenous Glucose Production (EGP) during Study 2
Ketone Body Turnover (ketogenesis) during Study 1
+1 moreSecondary outcome measures
Plasma Free Fatty Acids (FFA) Study 1
Plasma Free Fatty Acids (FFS) Study 2
Plasma Insulin Concentration Study 1
+1 moreSide effects data
From 2023 Phase 1 & 2 trial • 29 Patients • NCT0490721417%
Skin infection
17%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Empagliflozin
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EmpagliflozinExperimental Treatment1 Intervention
Administration of Empagliflozin 25mg administered at time zero.
Group II: Placebo/Control GroupPlacebo Group1 Intervention
Administration of placebo for empagliflozin 25mg administered at time zero.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin 25 MG
2018
Completed Phase 4
~390
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
453 Previous Clinical Trials
91,400 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,562 Total Patients Enrolled
Ralph DeFronzo, MDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio
11 Previous Clinical Trials
1,084 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on a stable dose of statin for at least 3 months.Your kidney function, measured by eGFR, is higher than 60 ml/min/1.73m2.I am not currently taking GLP-1 RA, DPP-4i, TZD, or insulin for diabetes.I do not have proliferative retinopathy or kidney issues (eGFR ≥ 60).I am being treated with diet, sulfonylurea, metformin, or both.Your weight has not changed much in the past 3 months, and you don't do very intense exercise.I am between 30 and 75 years old.Your HbA1c level is between 7.0% and 10%.I am not on medication that affects my blood sugar, except for SU/MET.I am in good health as confirmed by recent medical exams and tests.Your body mass index (BMI) is between 21 and 45.I am using birth control as a woman who can still have children.Your blood pressure should not be higher than 145 over 85.
Research Study Groups:
This trial has the following groups:- Group 1: Empagliflozin
- Group 2: Placebo/Control Group
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible to be a participant in this trial?
"To be considered for this medical trial, individuals with type 2 diabetes must meet the age criteria of being between 30 and 75 years old. There are a total of 30 spots available in this study."
Answered by AI
Is the age limit for inclusion in this trial under 75 years?
"The age bracket for this medical trial is set between 30 and 75 years old. There are 220 studies available for individuals below the former number, while those who exceed 65 have access to 1055 different trials."
Answered by AI
Are new participants being welcomed into this clinical experimentation?
"The clinicaltrial.gov entry for this medical trial indicates that it is no longer recruiting patients, as the last edit was dated July 21st 2023. Nonetheless, there are still 1,405 other trials actively seeking participants at this moment in time."
Answered by AI
What is the ultimate purpose of this experiment?
"The main purpose of this trial, which is measured between the start and 300 minutes mark, is to measure Endogenous Glucose Production (EGP) during Study 2. Other secondary objectives include gauging Plasma Insulin Concentration in Study 2, as well as recording changes made to Plasma Free Fatty Acids (FFA) and FFS during Studies 1 and 2 respectively."
Answered by AI
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