COMUNICADO: New Study Shows Exenatide Improves Blood Sugar Levels as Effectively as Insulin Glargine (1)

Actualizado 16/09/2006 15:46:41 CET

COPENHAGEN, Denmark, September 16 /PRNewswire/ --

-- Patients Taking Exenatide Lost Weight While Patients Taking Insulin Glargine Gained Weight

Eli Lilly and Company (NYSE: LLY) and Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced results from a study indicating that exenatide improves blood sugar levels as effectively as insulin glargine (Lantus(R), Sanofi Aventis) for people with type 2 diabetes failing to achieve acceptable blood sugar control on metformin or a sulfonylurea, two common oral diabetes medications. This is the third study demonstrating that exenatide can control blood sugar as effectively as insulin.(1)(2)

In this 32-week cross-over study, each patient received treatment with exenatide and insulin glargine for 16 weeks. Patients experienced similar reductions in hemoglobin A1C (HbA1C), or blood sugar levels, when treated with exenatide or insulin glargine. Forty percent of study participants reached target HbA1C of 7 percent or less when treated with exenatide compared to forty-one percent when they were treated with insulin glargine. Less than 7 percent is the target for good glucose control as recommended by American Diabetes Association (ADA). Twenty-four percent of patients on exenatide achieved target HbA1C of less than 6.5 percent compared with 14 percent when treated with glargine. The International Diabetes Federation (IDF) recommends a target HbA1C of 6.5 percent or less. These findings were presented at the 42nd annual meeting of the European Association of the Study of Diabetes (EASD) in Copenhagen, Denmark.

Exenatide treatment also resulted in an average reduction in body weight. After taking exenatide, patients on exenatide lost an average of 1.95 kilograms (4.3 pounds), but after taking insulin glargine, patients gained an average of 0.35 kilograms (0.77 pounds). In addition, exenatide significantly reduced postprandial glucose levels (peak levels after meals) compared to insulin glargine. Exenatide and insulin glargine treatment resulted in similar rates of hypoglycemia (low blood sugar) with a sulfonylurea, a therapy known to cause hypoglycemia when used alone. In combination with metformin, patients receiving exenatide treatment experienced fewer cases of hypoglycemia than when they were treated with insulin glargine.

"The results of this study demonstrate that exenatide could potentially be an effective treatment option for the management of type 2 diabetes patients who cannot control their blood sugar using oral medications," said Professor Anthony Barnett of the University of Birmingham and Birmingham Heartlands Hospital in the United Kingdom and a lead author of the study. "In addition to helping patients lower their HbA1C as effectively as insulin glargine, exenatide also helped patients lose weight -- an important factor in the management of type 2 diabetes."

Exenatide is the first in a new class of medicines known as incretin mimetics and was approved for use in the United States by the U.S. Food and Drug Administration in April 2005 for the treatment of type 2 diabetes. Exenatide is injected twice daily. The U.S. is the first country that has received regulatory approval for exenatide. In late 2005, Lilly submitted exenatide for approval in the European Union.

Key Findings

A1C reduction:

--- Both treatments achieved similar HbA1C reductions. Exenatide lowered HbA1C by 1.43 percent while insulin glargine lowered HbA1C by 1.41 percent.

--- When measured against the target HbA1C of less than or equal to 7 percent, 40 percent of patients achieved target HbA1C level of less than or equal to 7 percent when treated with exenatide, compared to 41 percent when treated with insulin glargine.

--- When measured against the target HbA1C level of less than or equal to 6.5 percent, 24 percent of patients receiving exenatide achieved this level compared to 14 percent when receiving insulin glargine.

Glucose measurements:

--- As measured by seven-point glucose monitoring, exenatide reduced postprandial excursions, the rise of glucose after meals, following breakfast and dinner.

--- The fasting blood glucose was significantly decreased from baseline for both treatments (exenatide, 3.04 mmol/L; insulin glargine, 4.17 mmol/L).

Weight change:

--- Weight loss in the exenatide arm: Patients treated with exenatide experienced an average weight reduction of 1.95 kilograms (4.3 pounds).

--- Weight gain in the insulin glargine arm: On average, patients treated with insulin glargine gained 0.35 kilograms (0.77 pounds).


--- Hypoglycemia occurred in a greater percentage of patients treated with a sulfonylurea (30 percent exenatide, 35 percent insulin glargine) compared with patients treated with metformin (3 percent exenatide, 17 percent insulin glargine).

Other adverse events:

--- The most common adverse event for exenatide was nausea (33.1 percent for exenatide, 3.9 percent for insulin glargine), which was generally mild-to-moderate and tended to decrease in frequency and severity over time.

Study Design/Protocol

141 patients were enrolled in the 32-week, multi-center, open-label, randomized, two-arm, cross-over trial. The trial was designed to determine if exenatide can be used as safely and effectively as insulin glargine in type 2 diabetes patients inadequately treated with metformin or a sulfonylurea.

Study participants were randomized during two, 16-week treatment periods. One group first received a dose of exenatide (5 micrograms twice-a-day for first four weeks, then 10 micrograms twice-a-day for 12 weeks), in conjunction with metformin or a sulfonylurea, and then crossed over to insulin glargine. The second group first received insulin glargine (iterated using a treat-to-target algorithm to a fasting blood glucose of less than or equal to 5.6 mmol/L) for 16 weeks, again with metformin or a sulfonylurea, and then crossed over to exenatide. The average HbA1C at baseline was 8.9 percent.

About exenatide

Exenatide is the first incretin mimetic, a new class of drugs for the treatment of type 2 diabetes. Exenatide exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1, secreted in response to food intake, has multiple effects on the intestine, liver, pancreas and brain that work in concert to regulate blood sugar.(3)

About Incretin Mimetics

Incretin mimetics are a distinct class of treatment in the fight against diabetes. An incretin mimetic works to mimic the anti-diabetic or glucose-lowering actions of naturally occurring human hormones called incretins. These actions include stimulating the body's ability to produce insulin in response to elevated levels of blood sugar, inhibiting the release of a hormone called glucagon following meals, slowing the rate at which nutrients are absorbed into the bloodstream and reducing food intake. Exenatide is the first FDA-approved incretin mimetic.

About Diabetes


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