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Contact: Will Sansom, (210) 567-2579

SAN FRANCISCO (June 11, 2008) — In a research study of hundreds of patients facing the prospect of developing type 2 diabetes, the oral drug pioglitazone (brand name: Actos®) reduced the rate of individuals being diagnosed with diabetes by 81 percent. The study compared patients taking the drug with those taking a placebo. The study leader, Ralph A. DeFronzo, M.D., reported the finding June 9 during the 68th Scientific Sessions of the American Diabetes Association in San Francisco.

Improved insulin production and blood sugar control
Individuals who took pioglitazone also improved their insulin production and their bodies became more sensitive to insulin, so that they were using insulin more efficiently to control their blood sugar, Dr. DeFronzo, professor and chief of diabetes at The University of Texas Health Science Center at San Antonio, said. He designed and led the four-year ACTos NOW for the Prevention of Diabetes (ACT NOW) Study that enrolled 602 individuals with impaired glucose tolerance, a prediabetic state, along with 102 healthy controls.

Currently no drug is approved by the U.S. Food and Drug Administration to treat prediabetes to prevent its progression to diabetes.

Ralph A. DeFronzo, M.D., led the study showing that pioglitazone (brand name: Actos®) significantly reduces the risk of prediabetic patients developing diabetes.

Study conducted at eight diabetes centers in U.S.
The maker of Actos®, Takeda Pharmaceuticals of Japan, funded the study but gave the researchers complete freedom to perform the study and interpret the results, whether positive or negative, Dr. DeFronzo said. The study was conducted at eight of the foremost centers for diabetes in the United States. The American Diabetes Association labeled the ACT NOW presentation late breaking and clinically relevant.

Pioglitazone corrects two major concerns in type 2 diabetes — insulin resistance and beta cell failure. Beta cells are the cells in the pancreas that secrete insulin. “The drug is the best insulin sensitizer we have and it also preserves beta-cell function,” Dr. DeFronzo said. “The clinical response in this study is next to astronomical, not 100 percent but obviously highly significant.”

First U.S. pioglitazone studies conducted at the Health Science Center in 2000
Pioglitazone was introduced to the U.S. in 2000 and the original studies to find out how it worked were conducted in the UT Health Science Center’s division of diabetes in the School of Medicine. The ACT NOW study was conducted with patients in the clinical research area of the Texas Diabetes Institute, a comprehensive diabetes treatment and research facility staffed by Health Science Center faculty physicians in a University Health System facility on San Antonio’s West Side.

About 1 in 10 individuals with impaired glucose tolerance shows signs of diabetic retinopathy (damage to blood vessels in the retina that may affect vision), and 5 percent to 10 percent of prediabetic individuals are estimated to have peripheral neuropathy (blood vessel damage in extremities). A drug to treat impaired glucose tolerance and prevent further decline is therefore of great importance. “Prediabetes, I believe, is really diabetes,” Dr. DeFronzo said.

In the ACT NOW study, 10 subjects with impaired glucose tolerance developed diabetes while taking pioglitazone. That compared to 45 subjects with impaired glucose tolerance who developed diabetes after receiving a placebo. Patients were randomly assigned to receive either pioglitazone or a placebo.

Forty-two percent of individuals in the pioglitazone group returned to normal glucose tolerance level at the end of the study versus 28 percent of those who were taking the placebo.

According to the study, pioglitazone was safe and well tolerated by patients. Weight gain and swelling were reported more frequently in the treatment group.

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The University of Texas Health Science Center at San Antonio is the leading research institution in South Texas and one of the major health sciences universities in the world. With an operating budget of $576 million, the Health Science Center is the chief catalyst for the $15.3 billion biosciences and health care sector in San Antonio’s economy. The Health Science Center has had an estimated $35 billion impact on the region since inception and has expanded to six campuses in San Antonio, Laredo, Harlingen and Edinburg. More than 23,000 graduates (physicians, dentists, nurses, scientists and allied health professionals) serve in their fields, including many in Texas. Health Science Center faculty are international leaders in cancer, cardiovascular disease, diabetes, aging, stroke prevention, kidney disease, orthopaedics, research imaging, transplant surgery, psychiatry and clinical neurosciences, pain management, genetics, nursing, allied health, dentistry and many other fields. For more information, visit www.uthscsa.edu.