CIR-0602K for Type 1 Diabetes
(WBH003 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment, CIR-0602K, for individuals with type 1 diabetes. The goal is to determine if this drug can maintain blood sugar levels in a healthier range for longer and reduce daily insulin requirements. Researchers will compare CIR-0602K to a placebo to assess its effectiveness. This trial may suit those who have had type 1 diabetes for at least a year, use automated insulin delivery systems, and meet specific health criteria. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant diabetes research.
Will I have to stop taking my current medications?
The trial requires that you have been on a stable regimen of non-diabetic medications for the last 6 months. You cannot use any antihyperglycemic medication beyond insulin or have unstable doses of certain medications like blood pressure drugs. Daily use of anti-inflammatory medications is also not allowed.
Is there any evidence suggesting that CIR-0602K is likely to be safe for humans?
In earlier studies, more than 300 people used CIR-0602K for up to one year. The treatment was well-tolerated, and no major safety issues were reported. This suggests that CIR-0602K might be safe for humans. However, it is important to remember that all medicines can have side effects. Further research will help confirm its safety.12345
Why do researchers think this study treatment might be promising for type 1 diabetes?
Most treatments for Type 1 Diabetes rely on insulin therapy to manage blood sugar levels. However, CIR-0602K is unique because it targets the underlying autoimmune process that causes the body's immune system to attack insulin-producing cells. Researchers are excited about CIR-0602K because it uses a novel mechanism to potentially halt or slow down this immune attack, offering hope for a more long-term solution rather than just managing symptoms. This could represent a significant shift in how Type 1 Diabetes is treated, moving beyond symptom management towards addressing the root cause of the disease.
What evidence suggests that CIR-0602K might be an effective treatment for type 1 diabetes?
Research has shown that CIR-0602K may help people with diabetes manage their blood sugar levels more effectively. In earlier studies, individuals with type 2 diabetes experienced a noticeable drop in their HbA1c levels, a measure of blood sugar over time, and in their insulin levels. The treatment also improved how muscles use energy, enhancing the body's insulin efficiency. This trial will evaluate CIR-0602K for people with type 1 diabetes, with some participants receiving CIR-0602K and others a placebo. These encouraging results suggest that CIR-0602K might also benefit people with type 1 diabetes by helping them maintain their blood sugar within the target range longer and reducing their daily insulin needs.12367
Who Is on the Research Team?
William B. Horton, MD
Principal Investigator
University of Virginia
Are You a Good Fit for This Trial?
This trial is for individuals with Type 1 Diabetes who may also have insulin resistance. Participants should be using a closed-loop automated insulin delivery system. The study excludes those with recent ketoacidosis, other serious health conditions, or taking medications that affect blood sugar.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants undergo baseline assessments and begin treatment
Treatment
Participants take either CIR-0602K or placebo, wear a CGM, and monitor ketone levels
End-of-Study
Participants return study equipment and complete final assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CIR-0602K
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor