EMBARGOED FOR RELEASE: 6:00 PM EDT, 6/14/98
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STUDY DEMONSTRATES SMITHKLINE BEECHAM'S ROSIGLITAZONE LOWERS BLOOD SUGAR LEVELS IN TYPE 2 DIABETES
Novel Diabetes Drug Attacks an Underlying Cause of the Disease
Chicago, June 14, 1998 -- The investigational oral diabetes drug rosiglitazone maleate (Avandia(r), SmithKline Beecham) produces clinically and statistically significant lowering of blood sugar in type 2 diabetes patients, according to a study presented today at the annual meeting of the American Diabetes Association (ADA) 58th Annual Scientific Sessions. Blood sugar control is recognized by the ADA as the cornerstone for managing diabetes and preventing serious complications.
In the multi-center, placebo-controlled, phase III clinical trial, rosiglitazone 8 mg/day when used alone reduced blood sugar levels by up to 76 milligrams per deciliter (mg/dL) compared to the placebo group.
"This 76 mg/dL drop in blood sugar levels is impressive. In trials of this type, it is rare to see a reduction in blood sugar levels greater than 60 mg/dL with any single drug," says Barry Goldstein, MD, rosiglitazone study group investigator, and director, Division of Endocrinology, Diabetes and Metabolic Diseases, Department of Medicine, Jefferson Medical College, Philadelphia, PA. "Rosiglitazone's ability to improve blood sugar control may help patients better manage their disease. Improved control may delay or prevent some of the long-term complications of diabetes, such as blindness or kidney disease."
Diabetes mellitus is a chronic disease characterized by high blood sugar levels that result from defects in the body's ability to use and/or produce insulin. It can lead to blindness, heart disease, kidney failure and limb amputation. There are two main types of diabetes: type 1 and type 2. People with type 1 diabetes are usually diagnosed when they are children or young adults. The pancreas of a person with type 1 diabetes makes little or no insulin and these patients must inject insulin every day to live. Most people with diabetes have type 2, in which the pancreas keeps making insulin for some time, but the body can't use it very well. Eventually, many patients with type 2 diabetes will require insulin injections.
Rosiglitazone directly targets insulin resistance -- an underlying condition responsible for type 2 diabetes -- and is a member of a new class of diabetes agents called thiazolidinediones (TZDs), insulin sensitivity enhancers. In contrast to traditional type 2 diabetes medicines, which increase insulin production in the pancreas or decrease glucose output through the liver, rosiglitazone reduces the amount of insulin needed while improving glycemic control. In other studies, rosiglitazone has also been shown to have no clinically significant drug interactions with acarbose, digoxin, metformin, ranitidine, warfarin, and cytochrome P450-metabolized drugs, such as nifedipine and one of the most commonly prescribed oral contraceptives. Rosiglitazone Lowers Blood Sugar
The 26-week study included 493 patients, most of whom were receiving another oral diabetes drug at the time of study entry. Study participants were assigned to one of three groups: placebo, rosiglitazone 8 mg/day or rosiglitazone 4 mg/day. The study included periodic measurements of blood sugar and hemoglobin A1c (HbA1c) levels, which reflect average amounts of blood sugar over the preceding two to three months and are directly related to the risks of long-term complications.
Compared to placebo, blood sugar levels were reduced by up to 76 mg/dL in the group receiving the highest dose of rosiglitazone (8 mg/day). Results for the group receiving the lower dose (4 mg/day) demonstrated a 58 mg/dL reduction in blood sugar levels.
The effectiveness of rosiglitazone was further confirmed by measurement of HbA1c levels. In the study, HbA1c levels were reduced by 1.54 percent and 1.21 percent of total hemoglobin in the 8 mg/day and 4 mg/day dose, respectively.
"It is very exciting that we may soon have a new treatment option for type 2 diabetes," says Dr. Goldstein. "This treatment alternative -- which helps the body more effectively use its natural insulin -- may assist patients in managing their disease."
"This is a statistically and clinically significant drop in blood sugar levels, and may help patients meet the ADA treatment goals for blood sugar control," says James Gavin, MD, past ADA president and senior scientific officer of the Howard Hughes Medical Institute, Chevy Chase, MD. "Both patients and physicians recognize the importance of meeting the ADA goals, however, this has been difficult with current single-agent treatment regimens." Rosiglitazone Is Well Tolerated
Rosiglitazone was well tolerated. Overall, reported side effects occurred at similar frequencies in the placebo group and the rosiglitazone treatment groups. The most common adverse events reported in both groups included upper respiratory tract infections and headache. As is common practice, patients in the clinical trial were routinely tested for blood enzyme elevations that might suggest liver damage. "There have been no reported cases of idiosyncratic drug reactions leading to jaundice or liver failure in any of the ongoing phase III clinical trials," says Jai Patel, MD, group director, Diabetes and Metabolism, Clinical Research & Development, SmithKline Beecham. Of the nearly 5,500 type 2 diabetes patients enrolled in these trials, approximately 2,500 received rosiglitazone for a minimum of six months, with 1,400 receiving the drug for more than one year.
"In the study, rosiglitazone appeared to be free of clinically significant liver side effects," says Harold Lebovitz, MD, rosiglitazone study group investigator, and professor of medicine, chief, Endocrinology and Metabolism/Diabetes, and director of the Diabetes, Diagnostic and Treatment Center at State University of New York Health Science Center in Brooklyn. "This could potentially eliminate the need to perform costly and routine liver function tests on patients, if additional and continuing studies do not show evidence of any significant liver toxicity."
Discovered and developed by SmithKline Beecham, rosiglitazone is currently in phase III clinical trials.
SmithKline Beecham (NYSE: SBH) -- one of the world's leading health care companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products, and provides health care services including clinical laboratory testing, disease management and pharmaceutical benefit management.
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