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Empagliflozin for Diabetes

Phase 4
Waitlist Available
Led By Muhammad Abdul-Ghani, MD, PhD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial is testing if the autonomic nervous system is involved in liver glucose production in response to diabetes.

Who is the study for?
This trial is for adults with type 2 diabetes who are generally healthy and have normal kidney function (eGFR>60 ml/min). It's not open to those on insulin, GLP-1 RA or SGLT2 treatments, anyone with major organ diseases, reduced kidney function (eGFR <60), or type 1 diabetes.Check my eligibility
What is being tested?
The study tests Empagliflozin's effect on liver glucose production in response to increased sugar in urine due to blocked glucose uptake by kidneys. Participants will either receive Empagliflozin or a control treatment.See study design
What are the potential side effects?
Empagliflozin may cause urinary tract infections, dehydration, low blood pressure, ketoacidosis (high levels of acid in the blood), yeast infections and can affect cholesterol levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
effect of empagliflozin on autonomic nervous system
Secondary outcome measures
hepatic glucose production and uptake
Other outcome measures
hepatic fat content

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: TreatmentExperimental Treatment1 Intervention
empagliflozin 25 mg per day
Group II: controlPlacebo Group1 Intervention
matching placebo 1 pill per day
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?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,387 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,302 Total Patients Enrolled
Muhammad Abdul-Ghani, MD, PhDPrincipal InvestigatorDiabetes Division, UTHSCSA

Media Library

Dapagliflozin Clinical Trial Eligibility Overview. Trial Name: NCT03193684 — Phase 4
Hepatic Glucose Metabolism Research Study Groups: Treatment, control
Hepatic Glucose Metabolism Clinical Trial 2023: Dapagliflozin Highlights & Side Effects. Trial Name: NCT03193684 — Phase 4
Dapagliflozin 2023 Treatment Timeline for Medical Study. Trial Name: NCT03193684 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants aged less than 85 years invited to join this experiment?

"This study is recruiting patients of legal age, who are between 18 and 65 years old."

Answered by AI

Are there vacancies to partake in this clinical experimentation?

"The clinical trial, initially posted on May 20th 2018 and last amended on November 9th 2022 according to the Clinical Trials database, is not presently accepting participants. However, there are 64 other medical studies that are currently enrolling patients."

Answered by AI

Are there any potential risks associated with a dosage of 10mg Dapagliflozin?

"There is ample evidence that suggests Dapagliflozin 10mg has a high safety rating, earning it an overall score of 3. This drug was approved after the completion of phase 4 clinical trials."

Answered by AI

What conditions is Dapagliflozin 10mg typically prescribed to treat?

"Dapagliflozin 10mg is largely used for pharmaceutical applications. Alternatively, it can be employed to help control dietary habits and physical activity, as well as augment the effects of monotherapy."

Answered by AI

Am I able to join in this clinical experimentation?

"108 patients will be accepted into this trial, which requires a healthy hepatic glucose metabolism and age between 18 and 65."

Answered by AI

Is this experiment innovative or merely a rehash of past research?

"AstraZeneca pioneered the first research on Dapagliflozin 10mg in 2014. After a successful clinical trial with 700 participants, N/A certification was issued to this medication. Currently 63 trials are ongoing around the world across 235 cities and 50 countries."

Answered by AI

How many participants are included within the scope of this clinical research study?

"At the moment, this medical trial is no longer accepting new participants; it was initially posted on May 20th 2018 and had its most recent update on November 9th 2022. If you are keen to join other studies, there's an active trial regarding hepatic glucose metabolism as well as 63 trials enrolling patients for dapagliflozin 10mg."

Answered by AI
~16 spots leftby Apr 2025