DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

Publication No. FS 02-9

(FDA Web site: www.fda.gov)

February 2002

New Products to Treat Diabetes

FDA Helps Counter a Major Public Health Threat

Diabetes mellitus is one of the

most prevalent and serious diseases in the United States. A

chronic ailment that impairs the

production of or response to

insulin, a hormone that helps

convert food into energy, diabetes

is diagnosed each year in 800,000

Americans and affects 16 million

of them. Type 1 diabetes is

diagnosed mostly in children and

teenagers; type 2, which accounts

for over 90 percent of the cases, is

usually found in older and overweight adults. Together they

contribute to about 200,000 deaths

a year. Diabetes is also the leading

cause of end-stage renal disease,

blindness in adults, and lowerlimb amputations.

To combat this public health

hazard, the Food and Drug Administration helps the industry

develop, evaluate and make

available a variety of products that

improve the diagnosis of diabetes

and help achieve tighter control of

blood glucose levels. Recent

advances toward this goal, which

reduces the diabetes-associated

risk of eye, nerve and kidney

diseases, include the following:

• New drugs to treat insulin

deficiency and control the level of

of carbohydrates.

• New devices to test, monitor,

and administer medications for

the treatment of both types of

diabetes that are more accurate,

less invasive and easier for patients to use. Tighter control of

blood glucose levels has been

facilitated by the FDA’s approval

of more than 100 glucose meters,

test systems, insulin pumps and

other devices that enable patients

to better manage their diabetes.

Other new devices for treating

complications of diabetes include

wound dressings and a skin

substitute for foot ulcers.

• New medications to reduce the

risk of heart disease, which

people with diabetes develop at

rates 2-4 times higher than normal.

In recent years, there has been a

major effort to develop antihypertensive drugs that reduce the risk

of heart attacks, strokes, and

diabetes-related deaths, as well as

lipid-altering drugs that target

abnormalities of cholesterol and

triglycerides that are observed in

diabetes.

For more information, visit the

FDA’s Web site at www.fda.gov/

diabetes.

blood sugar. Until the early

1980s, insulin preparations for the

treatment of diabetes were made

from animal products; since then,

most of them have been synthesized by recombinant DNA

technology. In the last decade, the

FDA has approved more than ten

new insulin products for types 1

and 2 diabetes, as well as several

new classes of oral medications to

treat type 2 diabetes. These new

drugs lower the blood sugar by

improving the body’s effectiveness in using insulin, rapidly

stimulating the secretion of

insulin, and decreasing absorption

A Disease on the Rise

Type 2 diabetes is becoming more

common in children and teenagers,

but it primarily affects non-white

Americans who are older and

overweight. Hispanics, blacks and

American Indians are almost twice as

likely to have diabetes as nonHispanic whites of the same age.

Because these and other diabetesprone minorities are among the

fastest growing segments of the

United States population, and

because Americans are increasingly

overweight and sedentary, the

incidence of diabetes in the United

States is expected to rise to nearly

9 percent of the population by 2025.