Did you know…. that 80% of clinical trials are delayed or terminated because of slow or low patient enrollment? Without clinical trials, scientists cannot verify new discoveries and pharmaceutical companies and other sponsors have less incentive to support advancing research.
Thankfully, you can help! Each month, we will highlight a clinical trial that is recruiting in our chapter or share information about the research institutions available to us in the Pacific Northwest. We believe that, as you learn about ongoing research, you will be heartened by the progress being made towards improved treatment and cures for T1D. We also hope that those of you living with T1D will be empowered to participate in one or more trials yourself.
This month, we would like to highlight two T1D trials taking place at Rainier Clinical Research Center (RCR) located in Renton WA. RCR was started over 30 years ago and is still run by its original founders. Started by Endocrinologists, Ronald Brazg and Leslie Klaff, RCRC has conducted over 600 trials focused on diabetes management and treatment innovations.
1: Study Name: OPT101
RCRC is working with Op-T to evaluate the safety of a medication and observe if it will change or reduce the level of Th40 cells, which are one of the main drivers of chronic inflammation and loss of pancreatic function associated with Type 1 Diabetes. Th40 has been found to be elevated in individuals with Type 1 Diabetes. OPT101, the new trial medication, is aimed at reducing the level of these t-cells. This is a Phase 1B trial, with lab testing producing promising results for the reduction of Th40 and chronic inflammation.
Healthy participants must be 18-60 years old and diagnosed with Type 1 Diabetes within the last 20 years. This trial will include eight infusions of the medication, or placebo, to determine if it can control the level of TH40, and subsequently reduce chronic inflammation.
Study visits will take place at Rainier Clinical Research Center in Renton, WA. Participants will discuss study risks and potential benefits with RCRC clinical staff, including the Principle Investigators overseeing the trial. There will be 9 total visits to this study, each of which will last a minimum of 2 hours. Compensation is included for study participation.
Principal Investigator: Ronald Brazg, MD, FACE
2: Study Name: Lilly 18h-MC-BDCY
An additional study with Eli Lilly and Company explores the efficacy of once-weekly basal insulin in comparison to daily basal insulin. It will focus on individuals 18 and older with type 1 diabetes that have been treated using basal and bolus insulin. This is a Phase 3 trial, the data from which will be used for FDA approval. Weekly basal insulins could reduce injection hesitancy, improve compliance with use, and improve the quality of life for individuals with Type 1 Diabetes.
This study will run for 52 weeks and include 29 visits to the RCRC clinic. Participants will be provided either the weekly basal insulin or daily basal. They are asked to complete e-diaries, and will wear an unblinded CGM for the full duration of the study. Compensation is included for study participants, and RCRC staff are available to answer any questions relating to eligibility, risk, and study design.
Principal Investigator: Frances Broyles, MD
If you are interested in either of these trials please contact RCRC at:
WHAT PARTICIPANTS NEED TO KNOW
Before joining a clinical trial, all participants are carefully selected in accordance to study requirements. The potential risks and benefits of participation are thoroughly explained prior to admission. Each person then gives their informed consent prior to taking part in the study. Participants will not be required to pay anything out of pocket and no medical insurance is ever billed. Compensation for time and travel is offered based on study visits and procedures.
Participation is voluntary and a participant can withdraw from a clinical trial at any time. The study team may ask to continue monitoring that person for a period to assess any long-term effects of the treatment received in the study.
You can learn more about our ongoing trials and eligibility by contacting RCRC via cell at 425-251-1720, email at firstname.lastname@example.org or visiting the enrolling studies page at https://www.rainier-research.com/current-studies#!/.