Pill stops move to Type 2 diabetes

A pill called pioglitazone helped people at high risk of developing Type 2 diabetes avoid the disease during a study described Thursday in the New England Journal of Medicine.
Tyrone Harvey talks with Dr. Gail Nunlee-Bland about managing his diabetes. The drug pioglitazone works to control blood sugar by making patients more sensitive to their own insulin, researchers say. (Jacquelyn Martin/Associated Press)

A pill called pioglitazone helped people at high risk of developing Type 2 diabetes avoid the disease during a study described Thursday in the New England Journal of Medicine.

Based on the results of the study, the researchers estimated that one case of diabetes could be prevented if 18 high-risk people were treated for a year with pioglitazone, which is sold under the brand name Actos.

This was the largest reduction shown by any intervention, whether through diet, exercise or medication, said the study's senior author, Dr. Ralph DeFronzo, chief of the diabetes division at the University of Texas Health Science Center in San Antonio.

For the manufacturer-sponsored study, the researchers randomly assigned 602 people — all at high-risk of Type 2 diabetes — to receive either pioglitazone or a placebo and then followed them for an average of 2.4 years. The longest monitoring time was four years.

Fasting glucose was measured quarterly, and oral glucose tolerance tests were performed every year.

The average age of the participants was 52. Factors such as obesity, family history and impaired glucose tolerance put them at risk of diabetes.

In Type 2 diabetes, the body is inefficient at responding to the hormone insulin. Eventually, beta cells in the pancreas die, resulting in less insulin to handle demands. Sugar levels progressively increase, and blood vessels and organs can be damaged.

Pioglitazone is in the same class as rosiglitazone, a drug sold under the name Avandia whose use has been restricted by the U.S. Food and Drug Administration and Health Canada because of cardiovascular risks. Rosiglitazone was pulled from the market in Europe.

Weight gain a side-effect

While Ontario researchers have found pioglitazone less dangerous to the heart than rosiglitazone, it has been linked to weight gain, fluid retention and fractures related to bone loss. In the University of Texas study, those taking pioglitazone gained an average of 3.6 kilograms or 7.9 pounds. 

A total of 90 patients on pioglitazone and 71 on the placebo dropped out of the study.

The researchers said pioglitazone stimulates appetite while shifting fat around in the body, taking it out of muscle and the liver and beta cells in the pancreas and putting it in fat deposits under the skin.

The drug works to control blood sugar by making patients more sensitive to their own insulin, the researchers said.

Dr. Vivian Fonseca, president-elect of medicine and science for the American Diabetes Association, said diet and exercise are still the best therapies against developing Type 2 diabetes, followed by a drug called metformin.

The results with pioglitazone were excellent, Fonseca told Health Day News, but she noted a lack of long-term safety information for the drug in people with pre-diabetes.

Metformin is also cheaper and available as a generic and its side-effects are well known, she said.

"No drug is perfect," DeFronzo said of pioglitazone. "This particular medication does two things — improves insulin resistance and improves beta cell function, which are the two core defects of diabetes."

The study was funded by the drug's manufacturer, Takeda Pharmaceuticals.