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Issue 106 Item 6 Starlix Prevents Type 2 Diabetes

A possible treatment for “Pre-diabetes was presented at the World Congress of Cardiology in Sydney, Australia. New research says Starlix, the brand name for nateglinide, restores the normal pattern of insulin secretion in people with impaired glucose tolerance (IGT).

The study was funded by Novartis Pharmaceuticals Corp., the maker of Starlix, and was presented at the recent World Congress of Cardiology in Sydney, Australia.

This is the first study to assess Starlix in treating IGT. It also shows the merit of evaluating the drug in a new large-scale international trial, says Dr. Richard Pratley, director of clinical research and development for Novartis.

IGT is called pre-diabetes because people with the condition have blood glucose levels higher than normal but not high enough for a diagnosis of diabetes.

It’s estimated that as many as 150 million people worldwide, including 16 million Americans, have IGT. These people are at high risk for Type II diabetes, with a 40 percent to 50 percent chance of developing the disease within 10 years. IGT is also a major risk factor for cardiovascular disease.

The Starlix study included 288 people with IGT in six European countries. The subjects were randomly selected to take 30 milligrams, 60 milligrams or 120 milligrams of Starlix or a placebo before main meals for eight weeks.

At the start and the end of the study, the subjects’ blood glucose and insulin levels were measured at intervals for three hours after a standard meal. Insulin is necessary for the body to break down sugar, the basic fuel for the cells in the body.

The results showed Starlix enhanced early insulin secretion, and reduced both the size of blood glucose peaks and the total increase of blood glucose during the three-hour period following the meal.

The average insulin levels increased by 33 percent, to 60 percent, compared to the baseline in the three groups that received Starlix.

Starlix is one of two drugs — the other is valsartan — at the center of the largest trial ever to look at the prevention of diabetes and related cardiovascular disease. The international study, called NAVIGATOR, involves 7,500 patients in 40 countries, and is being conducted by Novartis, which makes both drugs.

"We did [the Starlix study] to determine the right dose of Starlix to be used in our NAVIGATOR trial," Pratley says. Based on the study results, the 60 milligram dose was selected for NAVIGATOR, he says.

The NAVIGATOR trial was launched in late 2001 and is expected to run until 2007. It will determine whether early detection of IGT and long-term use of the drugs nateglinide and valsartan can reduce or delay the development of Type II diabetes and cardiovascular disease in people who have IGT.

Valsartan is a drug used to treat high blood pressure. However, there’s growing evidence it may also improve insulin sensitivity and reduce the risk of developing Type II diabetes.

All the people enrolled in NAVIGATOR will start with a 30 milligram dose of Starlix for the first two weeks, and then move to the 60 milligram dose. People who can’t tolerate the 60 milligram dose have the option of going back to the 30 milligram dose, Pratley says.

Dr. Francine Kaufman, president-elect of the American Diabetes Association, says the Starlix study shows the drug may be beneficial in treating IGT, but more long-term research is needed.

"It’s encouraging that this can improve insulin secretion. Whether that, over time, will be sustained, whether it will be sufficient to avert diabetes progression obviously needs to be studied," says Kaufman, who is director of the Comprehensive Diabetes Center at Children’s Hospital of Los Angeles.

This type of drug research is one part of a larger effort to find ways to prevent people who have IGT from developing diabetes, Kaufman says. While drugs may someday prove useful, one of the best ways of controlling IGT is through healthy eating and exercise, she adds.

While this is a society that likes to find drugs for everything, that may not be the answer for IGT, Kaufman says.

"I think there is not going to be a quick and easy way to do this," she says.

The study was funded by Novartis Pharmaceuticals Corp