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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
Must not have
Patients treated with Glucagon-like peptide 1 receptor agonists (GLP-1 RA), Dipeptidyl Peptidase IV inhibitors (DPP-4i), Thiazolidinediones (TZD), or insulin are excluded
Subjects with evidence of proliferative retinopathy or eGFR < 60 are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 10 (study 4 and study 5)
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not currently taking GLP-1 RA, DPP-4i, TZD, or insulin for diabetes.
Select...
I do not have proliferative retinopathy or kidney issues (eGFR ≥ 60).
Select...
I am not on medication that affects my blood sugar, except for SU/MET.
Select...
I am using birth control as a woman who can still have children.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 10 (study 4 and study 5)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 10 (study 4 and study 5)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Endogenous Glucose Production (EGP)
Hemoglobin A1c (HbA1c)
Ketone Body Turnover (ketogenesis)
+1 moreSecondary study objectives
Plasma Free Fatty Acids (FFA)
Plasma Insulin Concentration
Plasma glucose concentrations
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: PioglitazoneExperimental Treatment1 Intervention
Pioglitazone 30 mg/day
Group II: Empagliflozin + pioglitazoneExperimental Treatment1 Intervention
Combination of empagliflozin (25 mg/day) plus pioglitazone (30 mg/day)
Group III: EmpagliflozinExperimental Treatment1 Intervention
Empagliflozin 25 mg/day
Group IV: Placebo/Control GroupPlacebo Group1 Intervention
Placebo control
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin 25 MG
2019
Completed Phase 4
~710
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
477 Previous Clinical Trials
92,801 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,284 Total Patients Enrolled
Ralph DeFronzo, MDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio
11 Previous Clinical Trials
861 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: Pioglitazone
- Group 2: Empagliflozin + pioglitazone
- Group 3: Empagliflozin
- Group 4: 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.