Sweet Hope

In the hunt for better treatments for the growing and related epidemics of diabetes and obesity, researchers may have uncovered an unlikely drug: sugar.

Tagatose is a natural, low-calorie sugar that has been used to sweeten such things as orange juice and candy in Europe. And, for a short time, it was used in Diet Pepsi Slurpees at 7-Eleven in the United States.

But now tagatose is in a yearlong clinical trial to show that it's not just a palate pleaser but a manager for the most common form of diabetes, Type 2. If the trial goes well, it could be a big step in tagatose becoming a medicine, and eventually, an uber-sweet diet aid, according to an article in February's Diabetes, Obesity and Metabolism.

The drug-approval process is complex, costly and often fruitless. But, researchers said, small, early tests of tagatose have been promising - there were no major side effects, like with Avandia and Actos, which lower blood sugar but carry the government's strongest warning about an increased risk of heart failure.

"The idea of sugar as a treatment is provocative," said Thomas W. Donner, a University of Maryland endocrinologist and diabetes researcher who co-authored the journal article. "It's in the way it's absorbed. What we need to see is the exact amount the blood sugar is lowered."

Controlling blood sugar is crucial for all diabetics, about 7 percent of U.S. adults and children, or 20.8 million people, according to the American Diabetes Association. In nine out of 10 new cases of Type 2, the people are overweight.

With the condition, the body improperly uses or does not produce insulin, a hormone needed to convert sugar in the blood into energy in the cells. When blood sugar spikes, it can lead to complications such as cardiovascular disease, kidney problems and blindness.

Donner said a study of 30 people he ran before the current, late-stage clinical trial showed that tagatose ingested before meals blunted the rise in blood sugar, probably because tagatose is metabolized differently from table sugar, or sucrose.

Tagatose is absorbed poorly, and Donner said that might affect the way it's stored. It also might stimulate insulin secretion.

One drawback is the potential for uncomfortable digestion as the bulk of the tagatose passes through the body. On the positive side, researchers say tagatose could be the only diabetes drug raising heart-protecting good cholesterol and acting as a cell-protecting antioxidant.

Donner conducted the first clinical trials of tagatose in the 1990s with funding from the ÀôÀ drug's developer, the Beltsville-based biotechnology firm Spherix Inc. He has no stake in Spherix and is not participating in the current trial.

Tagatose is a naturally occurring version of fructose, the sugar in fruit. Spherix derived it from whey, a dairy byproduct.

Spherix founder Gilbert V. Levin first wanted tagatose to help space explorers find life on Mars. It couldn't withstand heat, so other compounds were used in testing.

Levin then saw potential in the $2 billion artificial-sweetener market because tagatose resembled cane sugar but had 40 percent fewer calories. "Naturlose" was patented in the 1980s and won approval in the 1990s by the U.S. Food and Drug Administration for use in food.

Its big break in the United States came in 2003 with the Diet Pepsi Slurpees. A Pepsi spokeswoman said they were sold for about three years. The Danish company that Spherix licensed to make tagatose stopped production because the product didn't sell well in Europe and Australia; that made it no longer available to Pepsi.

Spherix blamed inadequate marketing. But tagatose was also expensive, making it better suited to the pharmaceutical industry that often spends hundreds of millions to develop a drug.

So Spherix dropped the sweetener business, but Levin said all the consumption proved tagatose wasn't toxic, a pitfall in many drug trials. And he'd still like to see the drug delivered in a patient-pleasing chocolate bar.

Levin said the current trial will take another year. If results are good, Levin said, he hopes to partner with a well-heeled pharmaceutical firm to take the drug to market. His small biotech firm has already sold an unrelated subsidiary and launched a consulting business to get this far.

"This could be a wonderful example of how a small company that is really determined can be successful, if we are successful," he said. "We've already gotten to a place many major companies haven't gotten."

Donner, also medical director of UM's Joslin Diabetes Center, said that if the drug works on diabetes, there could be more trials to prove it works on fat. He has already found, to his surprise, that people in past trials lost weight.

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