Empagliflozin for Diabetes Post-Islet Transplant
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness and safety of the diabetes drug empagliflozin for individuals who have undergone an islet autotransplant, a procedure that relocates insulin-producing cells to the liver. It targets those with some remaining islet function who need additional diabetes management support. Participants will either begin without medication and then switch to empagliflozin or take varying doses of the drug over six months. Suitable candidates have managed diabetes for over a year post-transplant and can monitor their insulin use with a glucose monitor. As a Phase 4 trial, this research aims to understand how this FDA-approved treatment can benefit more patients.
Do I have to stop taking my current medications for the trial?
The trial requires that you have not taken any non-insulin diabetes medications in the past 4 weeks. If you are on insulin, you can continue using it, but you must be willing to manage your diabetes medication with the study team.
What is the safety track record for empagliflozin?
Research has shown that empagliflozin is generally safe for individuals who have undergone organ transplants. In studies involving kidney and heart transplant patients, empagliflozin effectively managed blood sugar levels and was well-tolerated. Most patients did not experience serious side effects, but regular monitoring remained important for safety.
One study found that empagliflozin could be safely added to other diabetes treatments with close monitoring by doctors, helping to catch any potential issues early. Overall, evidence supports the safety of empagliflozin for managing diabetes in transplant patients, but regular check-ups are essential.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about empagliflozin for diabetes management after islet cell transplants because it offers a new approach compared to standard insulin therapy. Unlike traditional treatments that primarily focus on replacing insulin, empagliflozin works by helping the kidneys remove excess glucose from the body through urine, which can effectively lower blood sugar levels. This unique mechanism may provide an added benefit of reducing the burden on transplanted islet cells, potentially enhancing their longevity and function. Additionally, empagliflozin is taken orally, which can be more convenient for patients compared to injectable insulin.
What evidence suggests that empagliflozin might be an effective treatment for diabetes post-islet transplant?
Research shows that empagliflozin effectively lowers blood sugar levels in people with diabetes. Studies have found that it significantly reduces HbA1c, a key measure of blood sugar control, and aids in weight loss. In patients who have had a kidney transplant, empagliflozin lowered uric acid levels, which can be beneficial. It is also considered safe for long-term use in managing diabetes for those who have had a heart transplant, offering various health benefits. This trial will evaluate empagliflozin's potential to help manage diabetes in people who have had islet transplants and still retain some islet function. Participants in this trial will be assigned to different treatment arms, receiving empagliflozin at varying dosages and durations, to assess its effectiveness and safety in this specific population.12367
Who Is on the Research Team?
Melena Bellin, MD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 with diabetes after total pancreatectomy and islet autotransplantation, who have partial islet function. Participants must not be on any diabetes meds except insulin, can manage their condition stably, and are willing to monitor glucose and attend study visits. Pregnant women or those planning pregnancy soon, people with severe allergies to empagliflozin or milk protein (in Boost HP), recurrent dehydration issues, recent diabetic ketoacidosis history, underweight individuals, non-English speakers, or those with renal failure cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either no medication, 10 mg Empagliflozin, or 25 mg Empagliflozin for a total of 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Empagliflozin
Trial Overview
The SIT trial tests the safety and effectiveness of a diabetes medication called empagliflozin in patients who've had an islet cell transplant. The drug comes in two doses (10 mg and 25 mg) taken orally. It's a pilot study designed to see how well this medication helps maintain blood sugar levels in these specific patients.
How Is the Trial Designed?
3
Treatment groups
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Citations
1.
diabetesjournals.org
diabetesjournals.org/care/article/42/6/1067/36035/Efficacy-and-Safety-of-Empagliflozin-in-RenalEfficacy and Safety of Empagliflozin in Renal Transplant ...
Glycemic Control The median change in HbA1c was significantly reduced after 24 weeks of empagliflozin treatment compared with placebo (Table 2).
Empagliflozin in kidney transplant recipients with chronic ...
The results showed that empagliflozin-treated patients had significantly HbA1c, uric acid and body weight reduction, and than placebo-treated ...
3.
journals.lww.com
journals.lww.com/transplantjournal/abstract/2018/07001/impact_of_empagliflozin_for_the_treatment_of.144.aspxImpact of Empagliflozin for the Treatment of Diabetes...
Empagliflozin appears to be safe for use in the long-term management of PTDM following heart transplantation. There may also be a range of metabolic benefits, ...
SGLT2i Therapy in Islet Transplantation (SIT)
This pilot clinical trial is designed to gather preliminary data on the efficacy and safety of empagliflozin, a diabetes drug in the sodium- ...
Effect of Empagliflozin on Tacrolimus-Induced Pancreas ...
Em reduced hyperglycemia and increased plasma insulin level, pancreatic islet size, and glucose-stimulated insulin secretion compared to the TAC group. In ...
Empagliflozin in posttransplantation diabetes mellitus
These results suggest that empagliflozin can safely be used as add-on therapy, if posttransplant diabetes patients are monitored closely.
Effects of SGLT2 inhibitors on transplant survival and key ...
Both studies showed that empagliflozin is safe and effective in the treatment of diabetes in patients with cardiac transplants. In another study ...
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