New study could hold promising news for Diabetics
Related Links
For information about the DEFEND study, or to locate the nearest clinical site, go to http://www.clinicaltrials.gov. Then type the trial identification number in the search box: NCT00678886. Information is also available at http://www.defendagainstdiabetes.com.
For general information on type 1 diabetes:
American Diabetes Association, http://www.diabetes.org, or contact your local chapter
Centers for Disease Control and Prevention, http://www.cdc.gov/diabetes
Juvenile Diabetes Research Foundation, http://www.jdrf.org
National Institute of Diabetes and Digestive and Kidney Diseases, http://www.niddk.nih.gov
Published: November 9, 2009
Sunday night, 11 Connects told you about a new study which could help prevent and overcome symptoms of Type 1 Diabetes by helping people make their own insulin. For more information, read the article by MedStar below.
About Diabetes
Diabetes is a condition that affects the ability of the body to use glucose (a form of sugar found in foods) for energy. Normally, specialized cells in the pancreas (islet cells) produce a hormone, called insulin. When we eat, this hormone acts like a key to unlock a cell and allow glucose to enter and be used as fuel.
Type 1 diabetes is caused when the body’s immune system inappropriately attacks the insulin-producing cells in the pancreas. The exact reasons for this attack are unknown, but genetics and environmental factors are probably involved. The body is unable to make its own insulin and patients need regular injections of insulin to regulate glucose levels.
According to the Centers for Disease Control and Prevention about 24 million Americans have diabetes. Type 1 is the less common form, accounting for 5 to 10 percent of all cases (roughly 1.2 to 2.4 million people). Although the disease can occur at any age, it’s most commonly diagnosed between infancy and young adulthood. Over time, high levels of glucose in the blood can damage the tissues and organs, increasing the risk for complications, like heart disease, stroke, kidney damage, blindness and nerve damage.
Defending Against Type 1 Diabetes
Islet cell destruction doesn’t occur overnight. For some time after diagnosis, patients typically have some functioning insulin-producing cells. This period of time, when there is still some residual insulin-production, is called the honeymoon phase. Researchers are now trying to figure out ways to preserve the function of these remaining cells and reduce the need for insulin injections.
One study underway is called DEFEND (Durable-response therapy Evaluation For Early or New-onset type 1 Diabetes). DEFEND is a Phase III clinical trial looking at a drug, called otelixizumab. Thomas Donner, M.D., Lead Investigator at the Joslin Diabetes Center/University of Maryland, says the drug is given through a half-hour intravenous infusion over 8 consecutive days. Otelixizumab is designed to target and attack the immune cells that are inappropriately killing the islet cells. Hopefully, that will preserve the body’s ability to make some of its own insulin and extend the honeymoon period after diagnosis.
The DEFEND study is enrolling participants ages 12 to 45 who have been recently (within 90 days) diagnosed with type 1 diabetes and are taking insulin injections. Two-thirds of the participants will randomly receive the otelixizumab infusions, and one-third will receive placebo infusions. Patients will be followed periodically for two years.
Earlier studies showed patients getting otelixizumab were able to use about 40 percent less extra insulin to control their blood sugar levels. Donner says he is hopeful the new trial shows the drug will also reduce the risk of low blood sugar reactions, which can cause confusion, loss of consciousness and, if not treated, death. Even if otelixizumab proves to be useful in preserving some insulin production, patients may need a booster treatment a year or two later to prevent more attacks by the immune system. Side effects of otelixizumab may range from mild to severe flu-like systems.
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