“The objective of this clinical trial (research study) is to determine if the medications can rescue the few beta cells that remain soon after the diagnosis of type 1 diabetes; and whether new beta cells can even be regenerated,” commented Alex Rabinovitch, MD, Principal Investigator of the trial and Associate Director of The Sanford Project. “The investigational combinations of these medications could possibly allow patients to decrease or no longer need to inject insulin to keep their blood levels under proper control.”
Early research of Dr. Rabinovitch, supported by Juvenile Diabetes Research Foundation, led to the discovery of a treatment that can regenerate insulin-producing pancreatic islet beta cells and showed promise in type 1 diabetes in mice. The Sanford Project has begun a clinical trial (research study) to test this novel beta-cell regeneration in patients with recently-diagnosed type 1 diabetes.
The trial, entitled REPAIR T1D (Restore Pancreatic Insulin Response in type 1 diabetes) is open to patients who meet the following requirements:
- Age 11-45
- Diagnosed within the last four months
- Able to come to Sanford for research visits
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 cells of the pancreas. It often strikes during childhood, makes patients dependent on insulin for life and carries the constant threat of devastating complications.
Dr. Rabinovitch’s former research team in Canada tested the same combination of two oral medications to be tested in this clinical research study. This blend regenerated pancreatic beta cells in mice with type 1 diabetes. Dr. Rabinovitch’s findings were published in the journal Diabetologia in June 2009. More recently, he has found this combination of medications could also stimulate adult human pancreatic duct cells to develop into insulin-secreting beta cells.
Based on these research studies, using mice and adult human pancreatic cells, Dr. Rabinovitch has developed a placebo-controlled research study (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 a flip of a coin, to a combination of two medications or placebo (inactive substance that looks the same as active medications).
Patients who have recently been diagnosed (within four months) with type 1 diabetes and are being treated with insulin may be eligible for this study.
Both medications under study are FDA approved drugs and are currently widely used on their own for other medical conditions. Sitagliptin is a drug found to control blood glucose in people with type 2 diabetes. Lansoprazole is prescribed as an antacid for heartburn. Although used in other conditions, this combination of agents in type 1 diabetes is investigational.
A total of 54 patients will be enrolled in REPAIR T1D. Thirty-six patients will receive test medications and 18 will receive placebos (inactive substance that looks the same as active medications), given as capsules, daily for 12 months, followed by a 12 month follow-up.
“I am very proud of The Sanford Project team’s early accomplishments,” stated Paul Burn, PhD, Todd and Linda Broin Chair and Director of The Sanford Project.
The Sanford Project has one goal: researching and curing type 1 diabetes. A $10 million gift from Todd and Linda Broin of Sioux Falls, SD to fund the chair of The Sanford Project accelerated its progress. Additional funding will be provided by the Juvenile Diabetes Research Foundation. In 2009, a team of international researchers, including Dr. Rabinovitch, joined The Sanford Project, which is currently located at the Sanford Center in northeast Sioux Falls.
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.
About The Sanford Project
The Sanford Project is one of the four initiatives made possible through Denny Sanford’s transformational gift to Sanford Health in 2007. From its inception, The Sanford Project was “designed for results.” Sanford Health will combine clinical components of patient care and science into one of the most promising and fast-moving fields of research; regenerative medicine. Their goal is to research and cure type 1 diabetes, all in pursuit of a healthy future for our children.
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Sanford Project press release http://www.sanfordproject.org/