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A Natural Sugar May Hold Promise as New Drug to Treat Type-2 Diabetes

Wednesday, February 27, 2008

 Thomas Donner, M.D. is making exciting progress in the treatment of diabetes.

University of Maryland endocrinologist co-authors article outlining possible benefits

A type of natural sugar called tagatose, already approved by the U.S. Food and Drug Administration (FDA) as a low-calorie sweetener, may prove to be an effective drug to treat people with Type-2 diabetes, according to an article in the February 2008 issue of the journal Diabetes, Obesity and Metabolism. The article was co-authored by Thomas W. Donner, M.D., a University of Maryland endocrinologist and diabetes researcher.

Tagatose - which is 92 percent as sweet as sugar (sucrose), with about a third of the calories - is currently being evaluated as a potential diabetes drug in a Phase III clinical trial sponsored by the Maryland company that developed it.

"It may seem odd to talk about using a sugar to treat diabetes, but clinical studies have indicated that tagatose has a positive effect on preventing high blood-sugar levels after meals," says Dr. Donner, the senior author, who is an associate professor of medicine at the University of Maryland School of Medicine and medical director of the University of Maryland Joslin Diabetes Center. "These spikes in blood sugar are a serious problem for people with diabetes, particularly because they may lead to complications, such as the development of cardiovascular disease."
According to Dr. Donner, a recent study of 30 volunteers who did not have diabetes found that tagatose ingested before a meal tended to blunt the rise in blood glucose that ordinarily occurs after consuming either sugar or starch. That small study was conducted as a prelude to the Phase III clinical trial.

In the mid-1990s, Dr. Donner conducted the first two clinical trials of tagatose, which was developed by a Beltsville, Md., company, Spherix, Inc., formerly known as Biospherics, Inc. He co-authored the February 2008 article in Diabetes, Obesity and Metabolism with two Spherix officials, Gilbert V. Levin, Ph.D., Spherix’s founder and director of science and technology, and Yongming Lu, Ph.D., the company’s manager. Dr. Lu is the lead author.

Tagatose is a sugar similar to fructose and can be found naturally in some dairy products. Only 20 percent of tagatose that is ingested is fully metabolized, principally in the liver, following a metabolic pathway identical to that of fructose. The FDA deemed it a safe sweetener for foods and beverages in 2001. The sugar substitute, marketed under the name Naturlose, is used in ready-to-eat cereals, sodas, mouthwash, toothpaste, lipstick and over-the-counter and prescription drugs.

In the article, "Tagatose, a New Anti-diabetic and Obesity-Control Drug," the authors outline the history, development and potential health benefits of the sugar in light of the expanding pandemic of Type 2 diabetes. They note that 20.8 million adults and children in the United States have diabetes, and nearly 9 out of 10 people newly diagnosed with Type-2 diabetes are overweight.

"In addition to its potential for treating Type-2 diabetes, tagatose shows potential for 
promoting weight loss and raising high-density lipoprotein (HDL) cholesterol, both important
ancillary effects in controlling diabetes," the authors say, adding that tagatose is also an
antioxidant and a prebiotic, both of which are considered important to good health.

Antioxidants are substances that may protect cells against the effects of damaging molecules known as free radicals. Prebiotics are substances that promote the growth of good bacteria (called probiotics) in the intestines. "No current therapies for Type-2 diabetes provide these multiple health benefits," the researchers say.

Spherix is conducting a one-year Phase III clinical trial of tagatose. Initial results of the placebo-controlled study are expected later this year.

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