Insulin producing islet cells

Clinical Trials

The DRI conducts research with the goal of translating findings from the lab to patients as quickly as possible. After a promising treatment is developed and its safety and effectiveness in the pre-clinical setting proven, clinical investigators obtain regulatory approval to conduct diabetes studies, or clinical trials, in patients.

DRI clinical trials offer participants the opportunity to play an active role in the research process and to access potential new therapies before they are widely available. These studies provide important information to advance medical research and are crucial to developing a cure for diabetes. Participants receive unparalleled care and related study procedures and medications throughout the trial at no cost. 

The DRI has received approval from the Food and Drug Administration to conduct several clinical trials. New studies in the final planning stages aim to halt the body's attack on its own insulin-producing cells that caused the onset of type 1 diabetes and preserve islet cell function. These important trials will be conducted in multiple centers at the same time in order to speed the collection of data and the development of meaningful therapeutic strategies for patients.

Participating in a clinical trial for diabetes or any other disease is an important personal decision. To learn more about what’s involved, the National Institutes of Health provides information about participating in clinical trials on its web site.  In addition, it is often helpful to talk to a physician, family members, or friends about deciding to join a trial.

Islet Transplantation Studies

Though progress has been substantial and, as a cell therapy, islet transplantation has allowed many patients to live without the need for insulin therapy, it remains an experimental procedure available only through clinical trial participation. Islet transplantation studies at the DRI continue to focus on improving the safety, long-term function, and success of islet replacement therapies and each one moves the needle of knowledge and patient application forward.

The DRI is currently midway through a Phase I/II clinical trial that will test the omentum, the interior lining covering abdominal organs, as an alternative transplant site to the liver, the traditional site. This pilot trial is a critical first step toward developing the DRI BioHub, a bioengineered mini organ that mimics the native pancreas.
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POSEIDON Trial (High-Dose Vitamin D and Omega-3 Fatty Acids)

Several studies have evaluated the role of inflammation in the progression of type 1 diabetes, and therapies aimed at blocking the inflammatory immune cells that cause the ongoing destruction of the insulin-producing cells have been tested in various intervention studies. The participation of children in these studies has been limited due to the toxicity of the therapeutic agents being used.

Now, data from recent case studies, as well as from emerging preclinical and clinical publications, support the possible role of combination therapy with high-dose vitamin D and Omega-3 fatty acids in stopping the progression of type 1 diabetes in new onset patients. 

DRI researchers will test this hypothesis in a new clinical trial. The POSEIDON study (Pilot Study of Omega-3 and Vitamin D High Doses in T1D) will compare the effects of the proposed intervention in children and adults newly diagnosed and in those with longer-standing type 1 diabetes to evaluate any benefit of this low-risk intervention.
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DIPIT (Diabetes Islet Preservation Immune Treatment) Trial

DRI scientists have observed over time that islet transplant outcomes differ substantially in terms of the duration of insulin independence achieved by the recipients. They found that those with prolonged insulin independence - 10 years or more - were treated with a combination of drugs, including one that promotes the growth of a population of immune cells that help suppress the attack on transplanted islets. The results were even better when coupled with a second drug that is commonly used in type 2 diabetes patients to enhance natural insulin production.

These findings, together with other study results using different drug combinations, have led DRI researchers to believe that a cocktail of multiple agents may be successful as a multi-path approach to address several challenges: halting the immune system attack, preserving the remaining islet function, and possibly, giving the body a chance to recover and regenerate its own islets.

The DIPIT trial will combine several different agents, given at varying time points, that have demonstrated significant benefits on transplanted islets when used alone or in small combinations of two or three of the drugs. The DRI has received approval from the Food and Drug Administration (FDA) to test the effects of this combination therapy in a Phase I/IIa clinical trial in a group of 42 patients, ages 18 - 35, who are within four months of diagnosis with type 1 diabetes.

All of the drugs have previously been used in patients for a variety of conditions, however, this is the first time that all of the agents will be used simultaneously in a specifically designed combinatorial trial. 

Once fully funded, this innovative trial will be conducted at the DRI and at multiple facilities throughout the United States. The data from this study may also provide vital information for developing treatment strategies in people with long-standing type 1 diabetes.
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Low-Dose IL-2 in Established Type 1 Diabetes

As mentioned in the Sustainability research section, immunoregulation offers a safer and more effective way of controlling immune responses using more natural substances to boost the levels of Regulatory T cells (T regs), the cells of the immune system that are decreased in quantity or impaired in people with autoimmune conditions, like T1D. When administered in low doses, the naturally occurring molecule interleukin 2 (IL-2) has demonstrated the ability to selectively boost the number of T regs.

Strong scientific support has already been generated for the use of IL-2 in clinical trials of several autoimmune conditions, including lupus, alopecia, graft-vs-host-disease (GVHD), vasculitis, and hepatitis-C. Additionally, IL-2 has been clinically tested for safety in dosing trials of type 1 diabetes by DRI collaborators in France.

The DRI has received FDA approval to conduct a multicenter clinical trial that will further explore the efficacy of this approach in young people with type 1 diabetes. The trial will include patients with disease duration up to one year post-diagnosis of T1D, extending beyond the typical enrollment window of less than 3 months. Insulin secretion is not always completely lost following diagnosis, and many patients maintain a significant amount of insulin production for at least two to three years, if not longer. This variabiity may afford the opportunity for scientists to intervene at clinical onset to try to save the surviving insulin-producing cells.
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Intraocular Islet Transplant

In this Phase I/II clinical trial, researchers are pursuing a novel method to establish immune tolerance by transplanting islets within the anterior chamber of the eye (ACE), testing its safety and efficacy as a potential site for islet transplantation in a very select group of patients. The eye is recognized as an immune-privileged site in the body and it could offer potential benefits in protecting the transplanted islets from immune attack in the ACE and elsewhere in the body.
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Type 1 Diabetes TrialNet

Sponsored by the National Institutes of Health (NIH), Type 1 Diabetes TrialNet conducts several studies aimed at slowing the immune system's attack on insulin-producing cells in people newly diagnosed with type 1 diabetes. Currently, TrialNet is focused on altering the immune system attack in order to delay or prevent type 1 diabetes in relatives found to be at risk for the disease. TrialNet studies are conducted by the Type 1 Diabetes TrialNet Study Group at multiple centers around the U.S. and internationally, including the Diabetes Research Institute.
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If you would like additional information about DRI clinical trials, please email us.

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