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Bend clinic part of an international study on drugs to ward off diabetes

Published: July 6, 2003
Kelly Kearsley
The Bulletin

The Bend Memorial Clinic is participating in an international study to see whether taking two different drugs could delay or prevent the development of Type 2 Diabetes.

"With the epidemic of obesity, we are seeing (an increase in diabetes) here as well as everywhere else," said Dr. Michael Harris, the primary investigator for the study.

Type 2 Diabetes occurs when the body doesn't produce enough insulin on its own or ignores insulin that it does produce.

Type 2 is different from Type 1 Diabetes, sometimes called Juvenile Diabetes, in which the body produces no insulin.

To keep the disease in check, people with Type 2 Diabetes monitor their blood sugar levels and control their diet, exercise and blood sugar every day, according to the American Diabetic Association.

About 17 million Americans are afflicted with the disease. People with diabetes are also at increased risk for heart attacks, strokes and other cardiovascular problems, Harris said.

The research study, if successful, means a combination of medications could result in reducing the number of those who are at risk for developing full-blown diabetes from ever getting there — and decrease their risk for cardiovascular problems in the process.

The study, sponsored by the Swiss-based pharmaceutical company Novartis, uses people who have a condition known as "pre-diabetes," meaning these people have higher than normal blood sugar levels, but do not have diabetes.

About 16 million Americans have this condition.

People who are 50-years-old or older and have any of the following elements in their life history may be at risk of developing diabetes and eligible to participate in Bend Memorial Clinic's research study:

Kim Callahan, spokeswoman for Novartis, said the clinical trial has already attracted 9,150 participants and is taking place in 30 to 40 countries. About 240 sites are taking part in the study in the United States.

Pam Bousquet, a research coordinator at Bend Memorial Clinic, said the clinic has seven people now enrolled in the study, but would like to have at least 12 people involved.

The clinical trial uses two drugs, both already on the market for other purposes, to see whether each could help those with pre-diabetes from progressing further into the disease, said Harris, the study's investigator.

One of the drugs is Starlix, the brand name of a drug used to lower blood sugar levels in patients who already have Type 2 Diabetes

The second drug is Diovan, the brand name of a drug used to treat hypertension, or high blood pressure.

Harris said people participating in the study will be taking a combination of Starlix and Diovan, while others will be taking one of the drugs and a placebo — an inactive substance — or two placebos.

The Bend Memorial Clinic will track the research participants for seven years after they begin the program, unless, Harris said, results surface earlier that the drugs are effective in preventing diabetes or are harmful to the patient.

However, Harris and Allison McCormack, the clinic's research manager, stressed that patient safety is a top priority in the clinic's research.

"This is pretty safe," Harris said. Both drugs have minimal side effects, he added.

Bend Memorial Clinic has been doing research since 1996.

There are three other active research studies going on now, said Dr. Keith Harless, medical director for the clinic's research department, and there may be more in the future.

The studies, Harless said, can benefit both Central Oregon patients and the medical clinic.

"Our patients who become research subjects generally enjoy the experience," he said.

Participants usually receive information on whatever condition they have or what the study is about, he said, and receive thorough and regular exams by physicians and, if needed, additional nutritional and fitness advice.

By joining such studies, Harless said the clinic's physicians get to participate in research, have access to the newest advances in medicine and the clinic gets paid by Novartis for its work.

Harless stressed that no doctors have a financial stake in any of the research.

For Harris, the research helps him help his patients using the newest medicine.

"I like being on the cutting edge in a safe environment," he said. "And it really affords patients access to the cutting edge medications as well."

Those interested in becoming part of the Navigator research study can contact Bousquet, at 318-3168.

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