OPF-310 for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called OPF-310, a potential drug for individuals with Type 1 Diabetes who experience severe low blood sugar episodes, even with advanced insulin pumps. The trial aims to determine if OPF-310 is safe, well-tolerated, and effective. Suitable participants have had Type 1 Diabetes for at least 5 years and have experienced severe hypoglycemic episodes at least three times in the past year, despite using a closed-loop system (a combined continuous glucose monitor and insulin pump) for at least 6 months. As a Phase 1 trial, this research focuses on understanding how OPF-310 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?
The trial does not specify if you need to stop taking your current medications, but it does exclude those on certain treatments like warfarin, corticosteroids, and non-insulin hypoglycemic medications. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that OPF-310 is likely to be safe for humans?
In a previous study, researchers examined the safety of OPF-310, a treatment using pig islet cells to manage Type 1 Diabetes. These cells are placed in a special protective capsule before transplantation into the body. This marks the first human trial of OPF-310, so scientists are still gathering safety data. The primary goal is to determine the treatment's safety and patient tolerance.
As this is the initial human study, information may be limited. However, researchers are closely monitoring for side effects or unexpected issues. This treatment aims to assist adults with severe Type 1 Diabetes who frequently experience low blood sugar despite current treatments.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for Type 1 Diabetes, which typically involve insulin injections and continuous glucose monitoring, OPF-310 is unique because it involves the transplantation of a novel compound. Researchers are excited about OPF-310 because it offers a potential new approach by addressing the underlying cause of diabetes rather than just managing blood sugar levels. This experimental treatment aims to restore insulin production, which could significantly reduce the need for external insulin and improve long-term outcomes for patients with Type 1 Diabetes.
What evidence suggests that OPF-310 might be an effective treatment for Type 1 Diabetes?
Research has shown that OPF-310, the treatment under study in this trial, might help people with Type 1 Diabetes manage their blood sugar levels more effectively. In early trials, patients achieved better blood sugar control and experienced fewer episodes of dangerously low blood sugar. This treatment uses pig islet cells, small groups of cells that produce insulin, covered with a protective layer to prevent immune system attacks. While the results are promising, further studies are needed to confirm its long-term effectiveness.13467
Are You a Good Fit for This Trial?
This trial is for adults aged 35-65 with unstable Type 1 Diabetes Mellitus, who've had severe low blood sugar episodes despite using advanced glucose monitoring and insulin pumps. Participants must have a history of diabetes for at least 5 years, an HbA1c level between 7.5% and 9%, very low or undetectable C-peptide levels, and agree to lifetime follow-up.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive OPF-310 transplantation to assess safety, tolerability, and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- OPF-310
Find a Clinic Near You
Who Is Running the Clinical Trial?
Otsuka Pharmaceutical Factory, Inc.
Lead Sponsor