Diabetes Clinical Trials

The Arthur Riggs Diabetes & Metabolism Research Institute at City of Hope  is committed to turning scientific discoveries into new strategies to treat, diagnosis, prevent and cure diabetes. Some clinical trials are designed to test the safety and/or effectiveness of promising new treatments that are not yet approved. Other studies gather information, such as questionnaires or blood samples, to help develop future treatment advances.

Diabetes Clinical Trials Inquiry Form

Ongoing Clinical Trials

IRB# 18156:  Improving Islet Transplantation Outcomes with Gastrin

ENROLLING ADULTS WITH TYPE 1 DIABETES
AGES 18-68 | 5 years or more from diagnosis

IRB# 23797: A Phase 1/2 Prospective, Randomized, Double-blind, Placebo-controlled Multi-center Clinical Trial to Determine the Safety and Efficacy of Denosumab in Improving Beta Cell Function and Glycemic Control Among Patients with Type 1 Diabetes

ENROLLING ADULTS WITH TYPE 1 DIABETES
AGES 18-50 | 1-5 years from diagnosis

IRB# 24745: A Randomized Phase 1/​2 Trial of Low Dose Anti-Thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes (WAVE T1D)

ENROLLING CHILDREN & YOUNG ADULTS WITH TYPE 1 DIABETES
AGES 9-20   |   Within 6 months of diagnosis

IRB# 25773: POLARIS: A Phase 1, Single Dose, Open-Label Study of GNTI-122 in Adults with Recently Diagnosed Type 1 Diabetes (T1D)

ENROLLING ADULTS WITH TYPE 1 DIABETES
AGES 18-55   |  Within 180 days of diagnosis

Search for other diabetes clinical trials research opportunities currently ongoing at City of Hope visit the clinical trials online page. 
Under the “Management Group” field, select “Medical Modality-Endocrine” for a listing of all open diabetes/endocrine studies.

Coming Soon

The following clinical trial(s) are not yet enrolling, but are coming soon.

IRB# 24895: Autologous CD6-CAR Treg Cells for Patients With Stage 3 Type 1 Diabetes

ADULTS WITH TYPE 1 DIABETES
AGES 18-35  | Within 12-24 months of diagnosis

Several new clinical trials are in development and expected to begin in the coming months/years. Please check back often.

Find Out If You May Be A Diabetes Clinical Trial Candidate

Complete our short online questionnaire to find out if you or someone you know might be a candidate for one of our recruiting clinical trials and/or to join our mailing list.

Contact Us

For diabetes clinical trial inquiries, contact our study coordinators via our toll-free line at 866-44-ISLET (47538), or email us at [email protected].

Wanek Family Project Research

Research within the Wanek Family Project will focus on these core areas:

Immune Modulation

At City of Hope, our experts are advancing breakthrough interventions that correct autoimmunity by regulating — instead of suppressing — the immune system. Our innovative approaches aim to restore a balanced immune system in order to stop its attack on insulin-producing beta cells. We are also endeavoring to reawaken or boost a patient’s remaining beta cells, or regenerate beta cells, in order to help them produce insulin on their own. These therapies represent a radical departure from traditional treatment methods that target the consequences of the disease rather than its cause (insulin insufficiency).

In recent years, research from our program has demonstrated that an approach involving mixed chimerism reverses autoimmunity in type 1 diabetes in mouse models. Mixed chimerism is achieved when the donor and recipient immune systems are combined and stable — establishing a new immune balance that halts the attack on insulin-producing cells. Our researchers continue to move toward clinical trials.

We are also conducting research aimed at balancing the immune system by expanding and re-engineering immune cells that control and direct the fight against disease. This new approach promises to both balance the immune system and provide a healthy environment for new beta cells to grow and produce insulin.

A sister project is the exploration of nano cell products that protect beta cells from destruction. This leading-edge research will be ready for clinical trial in the next few years.

Because of our strength in advancing immunology and immunotherapies for other diseases, including cancer, City of Hope is a particularly exciting place to explore cell-based, immune-modulating approaches to type 1 diabetes.

Recently, our investigators re-engineered a patient’s own immune cells to seek out cancer and mount an immune response —  harnessing the body’s own natural abilities to fight disease. Our first-in-human trials for these therapies demonstrate our ability to quickly translate science to the clinic, as well as our expertise in producing cell products for trial, which is a highly specialized process.

Beta Cell Expansion and Replacement

Renowned for our work in beta cell production and research, we are conducting studies to expand and boost insulin-producing cells and make them less susceptible to attack by the immune system.

Our beta cell replacement platform is unique among our peers, and we are continually creating improved methods of boosting and replacing beta cells, as well as imaging them in the body to encourage long-term survival.

Healthy beta cells produce and release insulin in response to glucose in the blood, and they are vital to treating and preventing diabetes. We now understand that some patients retain a store of “sleeping” beta cells, and our researchers are exploring ways to awaken these cells so that patients are able to produce insulin and achieve normal blood sugar levels.

We have developed a novel form of the naturally occurring growth factor gastrin, which in preclinical studies demonstrated its ability to significantly improve the survival of beta cells.

In particularly promising research, our experts are studying a series of beta cell proteins that are found at abnormally low levels in patients with diabetes. Lab research has shown that adding more of these proteins to beta cells improves their function, longevity and resistance to immune attack, and that adding “too many” proteins doesn’t hurt the cells. This implies that translating this approach to a therapy would be safe for patients.

We are also a national leader in developing islet cells for transplantation to treat patients with diabetes, with recognition on a national level as the coordinating center of the Integrated Islet Distribution Program.

As of 2015, this program has supported 341 studies that address multiple areas of diabetes research relating to islet cells. We are also the coordinating center of the Human Islet Research Network, a role in which we facilitate significant scientific advances in type 1 diabetes.

We are focused on addressing a major barrier to making islet cell transplant and other immune-modulating therapies more lasting and widely available to patients — namely, the shortage of islet cells that can be collected from human pancreatic tissue.

To create a lasting source of insulin-producing beta cells for transplant, we are developing new methods to promote differentiation from pancreatic stem cells into healthy islets. These methods will allow us to further increase the number of cells available for transplant, leading to lifesaving research.

This research builds on our strengths in biologics, using stem cells as well as genetic engineering. The approach is especially promising because stem cells are a renewable source of beta cells, meaning patients can generate many more islet cells from one pancreas than could be gathered by extracting only the mature islet cells.

Our team of researchers at City of Hope is the first in the world to apply imaging techniques to cell-based transplantation. Our efforts to monitor beta cells after transplant and identify signs of early demise in both native and transplanted cells will make it possible to stop cell injury, significantly advancing prevention efforts and strengthening transplant techniques.

Preventing and Reversing Diabetes Complications

For patients living with diabetes, complications can persist even when the disease is well-controlled with synthetic insulin and monitoring. Treatments that intervene at the genetic level to reverse complications have the power to bring healing. At City of Hope, we are developing novel interventions, built on our expertise in understanding the complex genetic modifications that cause complications.

City of Hope is home to diabetes experts from all over the world, who are studying genetic and epigenetic signatures in patients, using data from the most well-known, longest-ranging diabetes clinical trial.

Results from recent studies will help us identify which prediabetic patients are at high risk for developing the disease, and which patients will develop debilitating complications. This information will lay the groundwork for using precision medicine approaches to help patients coping with, or at risk for, type 1 diabetes.

Of particular importance is our research in metabolic memory, a phenomenon in which cells “remember” diabetes and act like they are still diseased, even after normal glucose levels are achieved. Molecular changes that create metabolic memory could be caused by epigenetic mechanisms.

The field of epigenetics provides crucial understanding about the ways that changes to genes caused by environmental factors drive disease, specifically chemical modifications on DNA and surrounding proteins that can alter the ways in which genes are expressed, even without the gene itself experiencing a mutation.

This means that harmful complications can persist — and that patients are in need of prevention and interventions that address metabolic memory specifically. Understanding epigenetic mechanisms and their contribution to the persistence of diabetic complications is critical because it could suggest alternative targets for therapy to halt and reverse complications.

Landmark research published by City of Hope researchers showed, for the first time, a connection between complex epigenetic mechanisms, blood glucose levels and diabetic complications in patients with metabolic memory. This research provides direction for novel therapies to address complications and their prevention.

Innovation Program

Often considered to be “high-risk, high-reward,” basic science research has the power to transform new ideas into powerful treatments that can change medical care for people all over the world. This type of science forms the foundation of the multidisciplinary approaches within the Wanek Family Project.

In order to create a robust pipeline of promising research for the Wanek Family Project, we are developing a program of early-phase research that will feed current and future studies aimed at preventing and curing type 1 diabetes. 

This program will consist of projects that are diverse in aims, with studies identified and prioritized by the impact that seed funding can be expected to have on advancing research within the Wanek Family Project. These projects will be prioritized by placing them in one of two categories:

  • Catapult Projects: Early-stage research that will be dramatically accelerated by an influx of funding. The promise of these studies and their impact on ready-go projects within the Wanek Family Project is already fairly certain. Examples include expanding clinical trials, exploring natural interventions to correct autoimmunity by harnessing the microbiome and developing an oral salmonella-based vaccine to prevent and cure type 1 diabetes.
  • Incubator Projects: A more speculative phase of research, funding for these projects will advance critical studies to fill in gaps of understanding and determine the clinical promise of the project.