Empagliflozin for Type 2 Diabetes

Overseen By Ralph DeFronzo, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: The University of Texas Health Science Center at San Antonio

Must be taking: Sulfonylurea, Metformin

Must not be taking: GLP-1 RA, DPP-4i

Disqualifiers: Proliferative retinopathy, eGFR < 60, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

29 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called Empagliflozin to determine its effects on people with Type 2 Diabetes. Researchers aim to understand its potential in controlling blood sugar and related processes. They seek participants who manage Type 2 Diabetes with diet or medications like metformin, but not insulin. Participants should have stable blood sugar levels and be in generally good health. The study aims to discover new ways to improve diabetes treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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 carries a low risk of causing low blood sugar and does not lead to weight gain. Notably, the EMPA-REG OUTCOME trial discovered that empagliflozin reduced the risk of death from heart problems by 38% compared to a placebo. Importantly, the trial found no new safety issues, even in patients with serious kidney disease. These results suggest that empagliflozin is safe for people with type 2 diabetes. ^{1 2 3 4 5}

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 glucose through urine. Unlike other treatments for type 2 diabetes, such as metformin or insulin, empagliflozin not only lowers blood sugar but also offers additional benefits like reducing the risk of heart disease and kidney problems. Researchers are excited about empagliflozin because it offers a new way to manage diabetes with potential cardiovascular and renal advantages, setting it apart from more traditional therapies.

What evidence suggests that empagliflozin might be an effective treatment for type 2 diabetes?

Studies have shown that empagliflozin, the treatment tested in this trial, effectively lowers blood sugar levels in adults with type 2 diabetes. Research also indicates that it benefits heart health by reducing the risk of heart-related problems in these patients. Additionally, empagliflozin has been linked to better health outcomes and lower death rates in people with existing heart conditions. While it helps manage blood sugar and heart health, it may increase the risk of a serious diabetes complication called diabetic ketoacidosis. Overall, empagliflozin has a strong track record in managing type 2 diabetes and its complications. ^{2 5 6 7 8}

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 adults aged 30-75 with Type 2 Diabetes, having a BMI of 21-45 and stable blood sugar levels (HbA1c between 7.0-11%). They should have normal kidney function, controlled blood pressure, and be on certain diabetes medications like sulfonylurea or metformin. Women must use contraception if able to bear children.

Inclusion Criteria

Body Mass Index (BMI) 21-45 kg/m2

Hemoglobin A1C (HbA1c) = 7.0-11%

Estimated glomerular filtration rate (eGFR) > 60 ml/min/1.73m2

Exclusion Criteria

I do not have proliferative retinopathy or kidney issues.

I am not on medication that affects blood sugar, other than SU/MET.

Women of childbearing potential are excluded unless they are taking/using appropriate contraceptive medications/devices

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Study Visits

Participants undergo various study visits involving prime-continuous infusions and ingestion of Empagliflozin to measure hepatic glucose production and lipolysis.

1 day per visit

4 visits (in-person), optional visits included

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Empagliflozin

Trial Overview The study tests whether Empagliflozin (a diabetes medication) causes increased glucose production, fat breakdown, and ketone body formation due to both dehydration and low insulin levels in people with Type 2 Diabetes.

How Is the Trial Designed?

Group I: Empagliflozin Experimental Treatment 1 Intervention

Empagliflozin 25 mg/day

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pro.boehringer-ingelheim.com pro.boehringer-ingelheim.com/us/products/jardiance/t2d/efficacy

T2D Efficacy Data | Jardiance® (empagliflozin) tablets Explore the efficacy and clinical trial data of JARDIANCE in reducing A1C levels for adults with type 2 diabetes. See Safety, Prescribing Info, & Med Guide.

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1504720

Empagliflozin, Cardiovascular Outcomes, and Mortality in ... In conclusion, patients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin had significantly lower rates of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9020632/

Treatment Outcomes of Graded Dose of Empagliflozin in ... Half-tablet empagliflozin (EMPA)-25 mg has lowest monthly cost among all EMPA preparations; data is unavailable on efficacy of half EMPA-25.

4. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.117.028268

Empagliflozin and Clinical Outcomes in Patients With Type ... Empagliflozin improved clinical outcomes and reduced mortality in vulnerable patients with type 2 diabetes mellitus, established cardiovascular disease, and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1262363622000994

Empagliflozin cardiovascular and renal effectiveness and ... For safety outcomes, initiation of empagliflozin was associated with a lower risk of acute kidney injury, increased risk of diabetic ketoacidosis, and similar ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4890479/

A Safety Evaluation of Empagliflozin for the Treatment of Type ... The evidence for empagliflozin is robust with regard to glycemic efficacy and safety. Low risk of hypoglycemia, absence of weight gain, and demonstrated ...

7. diabetesjournals.org diabetesjournals.org/care/article/45/6/1445/145036/Safety-of-Empagliflozin-in-Patients-With-Type-2

Safety of Empagliflozin in Patients With Type 2 Diabetes and ... Use of empagliflozin in patients with type 2 diabetes and advanced CKD raised no new safety concerns and may have beneficial effects on the development of ...

8. boehringer-ingelheim.com boehringer-ingelheim.com/us/media/press-releases/jardiance-empagliflozin-analysis-reinforces-established-safety-profile

Jardiance® (empagliflozin) T2D Analysis on Safety Profile The landmark EMPA-REG OUTCOME trial demonstrated that Jardiance reduced the risk of cardiovascular death by 38 percent versus placebo in people ...