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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
Statin therapy is permissible if the dose has been stable for at least 3 months
Patients treated with diet, sulfonylurea (SU), metformin (MET), or SU/MET
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 below
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I have been on a stable dose of statin for at least 3 months.
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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.
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I am in good health as confirmed by recent medical exams and tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 300 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 300 minutes for reporting.

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 more
Secondary outcome measures
Plasma Free Fatty Acids (FFA) Study 1
Plasma Free Fatty Acids (FFS) Study 2
Plasma Insulin Concentration Study 1
+1 more

Side effects data

From 2023 Phase 1 & 2 trial • 29 Patients • NCT04907214
17%
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
452 Previous Clinical Trials
91,384 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,315,036 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

Empagliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05960656 — Phase < 1
Type 2 Diabetes Research Study Groups: Empagliflozin, Placebo/Control Group
Type 2 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

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
~16 spots leftby Dec 2024