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TEMPLE RESEARCHER PARTICIPATES IN CLINICAL TRIAL FOR TYPE-1 DIABETES
January 2011 (from Temple Talk magazine)
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Elias S. Siraj, MD, principal investigator participating in DEFEND-2 clinical trial.
January, 2011 (from Temple Talk). Temple is participating in an international, randomized clinical trial to evaluate the safety and effectiveness of an investigational drug (Otelixizumab) in delaying the progression of disease in newly-diagnosed (90 days or less) patients with type 1 diabetes.
"We are currently participating in this important trial, called DEFEND-2, which holds a great deal of promise as a potential one-time treatment to delay or slow the progression of diabetes in a defined subset of the patient population," said prinicpal investigator Elias S. Siraj, MD, Associate Professor of Medicine and Director of Clinical Endocrinology at Temple University Hospital.
Diabetes (medically known as diabetes mellitus) is the name given to disorders in which the body has difficulty regulating high blood glucose (sugar) level. There are two major classes of diabetes: type 1 and type 2. Type 1, previously known as juvenile diabetes or insulin-dependent diabetes, is a disease in which the immune system mistakenly signals the body's T-cells to attack and destroy its own insulin-producing cells (beta cells) in the pancreas. The resulting decrease in the production of natural insulin means that patients must monitor their glucose levels frequently and give themselves insulin by injection or pump to control blood sugar levels.
According to Siraj, the DEFEND-2 trial (Durable-Response Therapy Evaluation for Early or New-Onset Type 1 Diabetes) is a follow-up study on the DEFEND-1 trial, in which Temple also participated. Those studies have come on the heels of smaller, earlier studies that have also used Otelixizumab, an investigational monoclonal antibody, as a therapeutic tool to modulate the immune system's response to diabetes. "Essentially, the drug targets a receptor in T-cells to impede the T-cells' ability to destroy insulin-producing pancreatic beta cells," explains Siraj. After receiving a single, 8-day course of infusions of Otelixizumab, study participants will be carefully monitored and assessed for improvement in their insulin-secretion. The drug will be administered as an addition to insulin, diet, and other standard-of-care treatments, as needed.
Temple has a well-established, multidisciplinary diabetes program within its Endocrinology Section that handles thousands of patient visits each year. The Program's physicians, researchers, nurses and nurse practitioners, and allied health professionals offer patients state-of-the-art therapies for the management of diabetes, including diabetes education, as well as the opportunity to participate in a rich variety of clinical trials designed to advance the treatment of diabetes.