National Stroke Foundation

Amaryl (Glimepiride)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved December 1995

Specific Treatments:

type II diabetes

Therapeutic Areas

General Information

Amaryl is an insulin-sparing sulfonylurea agent for the treatment of type II diabetes. It is indicated as a first-line therapy to lower blood glucose in people with type II diabetes whose high blood glucose cannot be controlled by diet and exercise alone.

Clinical Results

Clinical research supports the recommendation that Amaryl be used as a monotherapy or in combination with insulin, a unique distinction among members of the sulfonylurea class of diabetes drugs. Amaryl provided highly effective glucose control with a once daily dosing schedule, which helped many type II diabetes subjects achieve 24-hour glucose control, without putting subjects at undue risk for low blood sugar, a complication of overly rigorous control. Highly effective glucose control was observed in a range of subjects including obesity and hypertension--and in traditional at risk populations such as Hispanics and African Americans.

Additional Information

The incidence of diabetes in the United States is on the rise. The National Institute of Diabetes and Digestive Kidney Diseases estimates that 16 million Americans have diabetes mellitus, which represents an increase of five million compared with incidence of the disease 10 years ago. Yet, only half of the people believed to have diabetes have been diagnosed. Diabetes is the fourth-leading cause of death by disease in United States.

Type II diabetes, the more prevalent form of the disease, is often referred to as late-onset or non-insulin dependent diabetes mellitus (NIDDM). Of the eight million people diagnosed with diabetes, nearly 7.5 million have type II diabetes, and most of them require oral medication alone or in combination with insulin to keep blood sugar levels under control.

Studies on type I (insulin-dependent) diabetics in the landmark Diabetes Control and Complications Trial indicate that tight control reduced some of the devastating complications of the disease, such as retinopathy, kidney damage, and damage to the nerves that can lead to amputations. According to the American Diabetes Association, it is reasonable to recommend tighter glucose control for the millions of NIDDM subjects because it is presumed that the mechanisms by which glucose causes complications are the same in both forms of diabetes.