Empagliflozin for Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a medication called empagliflozin affects the body's process of breaking down fats and producing ketones in people with type 2 diabetes. Researchers are testing whether adding another drug, pioglitazone, can alter these effects. The trial targets individuals with type 2 diabetes who manage their condition with diet or specific oral medications and maintain stable overall health. Participants should not be using insulin or certain other diabetes medications. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a unique opportunity to contribute to groundbreaking diabetes research.
Will I have to stop taking my current medications?
If you are taking medications like sulfonylurea or metformin, you can continue them. However, if you are on medications like GLP-1 RA, DPP-4i, TZD, or insulin, you will need to stop them to participate in the trial.
Is there any evidence suggesting that empagliflozin is likely to be safe for humans?
Research shows that empagliflozin is generally safe for people with type 2 diabetes. Studies have found it has a low risk of causing low blood sugar and typically does not lead to weight gain. Empagliflozin might even reduce the risk of death from heart problems. In individuals with serious kidney disease, no new safety issues have emerged. Overall, the safety of empagliflozin is well-established, making it a promising option for managing type 2 diabetes.12345
Why do researchers think this study treatment might be promising?
Empagliflozin is unique because it belongs to a class of drugs called SGLT2 inhibitors, which work by helping the kidneys remove excess sugar from the body through urine. Unlike standard treatments for type 2 diabetes, such as metformin or insulin, which primarily focus on improving insulin sensitivity or supplementing insulin levels, empagliflozin offers a different approach by directly reducing blood glucose levels. Researchers are excited about this treatment because it not only helps control blood sugar but also has the potential to provide cardiovascular benefits and aid in weight loss, addressing multiple health concerns associated with type 2 diabetes.
What evidence suggests that empagliflozin might be an effective treatment for type 2 diabetes?
Studies have shown that empagliflozin, the treatment being tested in this trial, helps treat type 2 diabetes by lowering A1C levels, which measure blood sugar control. Research also indicates it reduces the risk of heart problems for people with diabetes who are at high risk for heart issues. Additionally, empagliflozin has improved overall health and lowered the risk of death in people with both diabetes and heart disease. Evidence also suggests it reduces the chance of kidney injuries, although it may slightly increase the risk of diabetic ketoacidosis, a condition where there is too much acid in the blood. Overall, empagliflozin shows promise for managing type 2 diabetes and its complications.25678
Who Is on the Research Team?
Ralph DeFronzo, MD
Principal Investigator
University of Texas Health Science Center San Antonio
Are You a Good Fit for This Trial?
This trial is for individuals with type 2 diabetes. Participants should be able to undergo specific tests and treatments as part of the study. The exact inclusion and exclusion criteria are not provided, but typically involve factors like age, disease severity, and absence of conditions that could interfere with the drug's effects or pose additional health risks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Study 1
Participants receive empagliflozin and undergo various infusions to measure hepatic glucose production, lipolysis, and ketogenesis.
Study 2 (Optional)
Participants receive empagliflozin with propranolol infusion to assess its effect on glucose production and lipolysis.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Empagliflozin
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San Antonio
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator