Sanford Project researchers have reached a critical milestone in a clinical trial testing a combination of two medications to determine if the drugs can help patients with type 1 diabetes keep their blood glucose levels under control with less or no insulin. In the trial termed REPAIR-T1D, two FDA-approved drugs, sitagliptin and lansoprazole, are evaluated for their potential clinical benefits in T1D patients.
“Using FDA-approved and market drugs in our translational research efforts is an important part of The Sanford Project’s strategy of identifying clinically relevant solutions and cures for patients with T1D in an accelerated manner,” says Paul Burn, PhD, the chair and director of The Sanford Project.
The research trial, part of Sanford Health’s commitment to deliver a cure for type 1 diabetes, is now also being offered to patients outside the Sanford system. Two-thirds of the patients have already been enrolled into the study. To date, the majority of patients were recruited from within the Sanford Health system in Sioux Falls, SD and Fargo, ND. To speed up recruitment, participation in the study is now being offered to patients from Children’s Hospital and Clinics of Minnesota in St. Paul, MN and Rady Children’s Hospital in San Diego, CA.
The clinical study is being led by Alex Rabinovitch, MD, senior scientist and associate director of The Sanford Project. His early pre-clinical research, supported by the Juvenile Diabetes Research Foundation, led to the discovery of a treatment that can regenerate insulin-producing pancreatic beta-cells in mice. The Sanford Project has begun a clinical trial to test this novel beta-cell regeneration therapy in patients with recently-diagnosed type 1 diabetes.
Research audiences nationwide are taking notice of the The Sanford Project. Science Magazine, Diabetes Forecast Magazine, Nature Biotechnology Journal and DOTmedbusiness News, recently covered Sanford Health’s research in the type 1 diabetes field.
Background
The Sanford Project, one of four initiatives made possible through Denny Sanford’s transformational $400 million gift, has one goal: to research and cure type 1 (juvenile) diabetes. It includes a world-class research team exploring new investigational treatment strategies including beta-cell regeneration and immunotherapy.
Type 1 diabetes currently affects about one million people in the United States. It is a disease in which the body’s immune system attacks and destroys insulin-producing islet beta cells of the pancreas. It often strikes during childhood, makes patients dependent on insulin for life and carries the constant threat of devastating complications.
Using a combination therapy of sitagliptin and lansoprazole, Dr. Rabinovitch’s former research team in Canada regenerated successfully pancreatic beta cells in mice with type 1 diabetes. Based on these research studies, he developed a placebo-controlled clinical trial (a study in which a percentage of patients take an inactive substance that looks the same as active medications). In addition, this study will be masked, meaning the patient, study doctor and study coordinator are blinded to what the patient is taking. Patients will be randomly assigned, similar to the flip of a coin, to a combination of two medications or placebo (inactive substance that looks the same as active medications).
For more information about The Sanford Project visit www.sanfordproject.org. To learn how to enroll in the REPAIR-T1D trial, call 605-328-1368. Further information on the trial can also be found at www.clinicaltrials.gov with the Identifier: NCT01155284.
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Posted In Endocrinology, News
