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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 below
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I am being treated with diet, sulfonylurea, metformin, or both.
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I am between 30 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not currently taking GLP-1 RA, DPP-4i, TZD, or insulin for diabetes.
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I do not have proliferative retinopathy or kidney issues (eGFR ≥ 60).
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I am not on medication that affects my blood sugar, except for SU/MET.
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I am using birth control as a woman who can still have children.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 10 (study 4 and study 5)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 10 (study 4 and study 5) for reporting.

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 more
Secondary 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
475 Previous Clinical Trials
92,147 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,444 Previous Clinical Trials
4,331,047 Total Patients Enrolled
Ralph DeFronzo, MDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio
11 Previous Clinical Trials
861 Total Patients Enrolled

Media Library

Empagliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05960656 — Phase < 1
Type 1 Diabetes Research Study Groups: Pioglitazone, Empagliflozin + pioglitazone, Empagliflozin, Placebo/Control Group
Type 1 Diabetes Clinical Trial 2023: Empagliflozin Highlights & Side Effects. Trial Name: NCT05960656 — Phase < 1
Empagliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05960656 — Phase < 1
~113 spots leftby Jun 2027
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