OU School of Medicine

PROJECT PURPOSE

The American Diabetes Association estimates that 554,400 Oklahomans, 14.3% of the population, have diabetes and 36.9%, or 1.1 million, have pre-diabetes. Serious complications of diabetes include heart attack, stroke, kidney disease requiring dialysis or transplant, blindness, amputations, several cancers, serious COVID-19 disease, and death. Unfortunately, diabetes costs taxpayers $3.2 Billion in Oklahoma annually. Injected insulin prevents acute death and complications of diabetes but the affordability of insulin remains a significant local and global challenge. 25% of diabetic patient?s skimp or even skip doses altogether due to the high cost of insulin, especially those affected by health disparities or underserved populations. The Harold Hamm Diabetes Center (HHDC), at OU-Health Sciences Center and OU-Tulsa, is a major diabetes research and treatment center in Oklahoma. HHDC is seeking $10.5 million to develop critical clinical trials infrastructure in collaboration with the Oklahoma Clinical and Translational Science Institute (OCTSI) which helps support clinical research throughout the state. We will carry out the final phase biosimiliar insulin study and develop the infrastructure necessary for future clinical trials using biosimilar insulin across Oklahoma. Expanding diabetes trial infrastructure will accelerate our pharmaceutical and federal funds coming to Oklahoma supporting high quality jobs and enhancing and expanding diabetes treatment.

EVIDENCE

All FDA-approved biological products, including biosimilar insulin, undergo a rigorous evaluation to ensure that patients can rely on their efficacy, safety, and quality. Biological products are the fastest-growing class of therapeutic products in the US and account for a substantial and increasing portion of health care costs. Congress, through the Biologics Price Competition and Innovation Act, created an abbreviated approval pathway to provide the public with greater access to safe and effective biological products. By elevating our HHDC-OCTSI clinical trials center, we will provide new treatments, lower health care costs, and increase access to lifesaving medications for Oklahomans

POPULATION DESCRIPTION

15% of Oklahoma Native Americans and African Americans have diabetes compared to less than 10% of Caucasians. Diabetes mortality rate is significantly higher for Oklahoma Native Americans and African Americans, at 60% and 56% respectively, compared to 20% for Caucasians. Additionally, diabetes increased the risk of COVID-19 serious illness, hospitalizations, and death by 10%, with even worse outcomes for the patients with poor diabetes control. Bringing cutting-edge diabetes therapies, including affordable biosimilar insulin to Oklahomans, will provide improved outcomes for Oklahoma patients ? regardless of ability to pay or insurance status. The HHDC-OCTSI is uniquely positioned to address these health disparities through expanded community engagement with tribes, African Americans, un-insured and under-insured interurban and rural patients by partnering with existing community care centers to enhance enrollment into our clinical trials. This outreach will include education, nurse navigators, social workers, and culturally-sensitive engagement. With access to safe and effective, affordable biosimilar insulins, patients across Oklahoma will achieve improved diabetes control, decrease diabetes complications, and improve the overall health and health care cost burdens for the state.

PERFORMANCE MEASURING

We will collect and report FDA mandated data necessary to approve biosimilar insulin. These metrics include data on recruiting, training, and specialized technical expertise and resources, as well as performance metrics including clinical outcomes and safety concerns. Our tests will prove that low-cost biosimilar insulin is as safe and effective as expensive insulin formulations. The outcomes will provide the much needed data not only for FDA approval, but for future large scale clinical trials designed for treatment of diabetes and its co-morbidities including (but not limited to) heart disease, kidney, eye, and cancer across the state of Oklahoma.

ONGOING INVESTMENT AMOUNT

$

ONGOING INVESTMENT DESCRIPTION

None

ONGOING INVESTMENT REQUIRED

Able to continue operation without additional funding from the State of Oklahoma