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|                                   | ## News Feature |                |
| **Veterans Affairs**              |                 |                |
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October 2000

#### For Diabetics, VA Study Could Hold Key to Better Treatment

As an Army mechanic in the 1960s, Joseph Komaerk used to fix jeeps,
trucks, bulldozers---"I worked on just about anything that had a motor
in it," he says. In civilian life, he built a successful auto-repair
business, now run by his sons.

At 58, the Iowa man should be looking forward to retirement with
grandchildren, fishing, lazy afternoons. But for Komaerk, the future is
anything but care-free.

Joseph Komaerk has type-II diabetes. His body can't properly use
insulin, the hormone that helps convert sugar from food into energy. As
a result, too much sugar stays in his blood. The short-term symptoms
include dehydration, blurred vision, headaches, fatigue. Over time, the
excess sugar can damage the cardiovascular system, eyes, kidneys or
nerves. Each day of his life, the Iowa mechanic must take medicine to
control his blood sugar. He monitors his body carefully. Every meal
eaten---or missed---can raise or drop his sugar to uncomfortable levels.
Low sugar could make him jittery, tired, hungry.

"It all depends on what I eat, how active I am," says Komaerk about his
blood sugar, which he checks twice daily at home by pricking his finger
with a lancet, wiping the blood onto a test strip, and reading the strip
in a small glucose meter with a digital read-out. "Right now, I'm having
a problem keeping it down. It stays close to 200 \[milligrams per
deciliter of blood\]." His target, when testing after meals, is 180
mg/dl or less.

Komaerk is already on near-maximum doses of two medications. The drugs
lower his blood sugar and help his body use insulin. How far can his
drug therapy safely be pushed? Does he also need insulin injections,
which are usually prescribed only after pills alone prove inadequate?
And if his sugar can be controlled, will that help prevent deadly
complications such as heart attack or stroke?

\- more -

VA clinical study - 2

These questions are at the core of a new clinical trial by the
Department of Veterans Affairs. The seven-year, \$57 million VA Diabetes
Trial will divide 1,700 diabetics into two groups: one group will be on
standard medication; the other will receive more intensive drug

therapy with similar medications. Patients will be watched closely for
changes in their health, especially cardiovascular disease. Chairing the
study are Carlos Abraira, M.D., of the VA Medical Center in Miami, and
William Duckworth, M.D., of the VA Medical Center in Phoenix. The study
is being conducted by the Cooperative Studies Program of the VA Research
Service and coordinated by its center at the Hines VA Hospital in
Chicago.

"Macrovascular complications, such as coronary heart disease and
peripheral vascular disease, are some of the greatest questions we face
in diabetes care, if not all health care," says Duckworth. "If we can
find a way to reduce these complications, it would have a major impact
on health care in the United States."

According to the American Diabetes Association, which is helping to
sponsor the VA research, diabetes costs the nation \$80 billion per
year. There are more than 16 million Americans with diabetes. At least
90 percent of them have type-II diabetes. In the VA health system, the
impact of diabetes is huge. Diabetes affects about one in six patients
seen in the VA health system, and accounts for more than 25 percent of
VA's pharmacy costs. The majority of diabetes-related hospitalizations
and deaths are due to cardiovascular complications such as heart attack
and stroke.

More aggressive treatment to stem cardiovascular disease for diabetics,
though, is not without risks. The likelihood of drug side-effects, such
as upset stomach, increases. And insulin therapy can have adverse
effects on people who are older, overweight and in poor cardiac
health---the typical profile of the type-II diabetic in the United
States. Both drugs and insulin, pushed too far, can drop blood-sugar too
low, causing shakiness, dizziness, sweating and other symptoms. That's
why scientists until now have not tested the benefits of intensive
glycemic control in this population.

"If it were easy to get glucose under control, this wouldn't be such an
important study," says Duckworth. "There are problems with therapy, and
we need to know what the limitations are. We hope the benefits outweigh
the costs---not only the financial costs, but the complications and the
effect on patients' quality of life."

\- more -

VA clinical study - 3

Added Abraira: "We're looking at care in the type of patient about whom
there has been a lot of debate. There's uncertainty as to what are safe
and effective glycemic goals for these patients. That's the main
question we're addressing."

For patients like Joseph Komaerk, the study could provide important
answers. He is a big man---6-feet-4 and more than 300 pounds---and has
already been through a triple bypass operation. His doctor recently
increased the dosage on one of his diabetes drugs, Metformin. The next
step would be insulin. Komaerk knows what that entails---his wife is
also diabetic, and has given herself insulin shots for years---and hopes
he can avoid it. More exercise would help; he walks and rides a
stationary bicycle when he can, but so far hasn't achieved a steady
routine. "A lot of times I'm on the go," he says. "It's hard to fit in
exercise."

Abraira and Duckworth believe the VA Diabetes Trial will contribute
important knowledge to help them and other physicians care for diabetics
and keep their cardiovascular systems healthy. But Duckworth added: "We
guide patients, help them along, encourage them, follow-up, catch things
as they happen---but ultimately everything depends on them."

*The VA Diabetes Trial is supported by the VA Cooperative Studies
Program, the American Diabetes Association, and four pharmaceutical
companies: SmithKline Beecham, Novo Nordisk, Aventis, and Roche
Diagnostics.*

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