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Most patients saw improvements in three critical measures of blood glucose control Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced detailed findings from a study that showed BYETTA(R) (exenatide) injection lowered blood glucose levels for people with type 2 diabetes who had not achieved target blood glucose levels despite the use of a thiazolidinedione (TZD) with or without metformin. Patients using BYETTA showed improvements in three important measures of blood glucose control: fasting blood glucose, postprandial blood glucose and hemoglobin A1C (A1C), which improved by approximately 0.9 percent compared to the control group. Sixty-two percent of study participants using BYETTA who completed the full study reached target A1C of 7 percent or less. Less than 7 percent is the target for good glucose control as recommended by American Diabetes Association (ADA).
BYETTA treatment also resulted in a reduction in average body weight. BYETTA-treated patients lost an average of approximately three pounds of body weight, while those treated with placebo lost on average approximately one-half pound.
"In the context of treating the underlying defects in people with type 2 diabetes — beta-cell dysfunction and insulin resistance — using combination therapies is a sensible approach for patients," said Bernard Zinman, MD, Director of the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital in Toronto, Ontario and a lead author of the study. "These data indicate that the addition of BYETTA to TZDs can be a clinically meaningful treatment for patients."
These findings were presented at the 66th Annual Scientific Sessions of the ADA in Washington, DC. BYETTA (pronounced bye-A-tuh), was approved in April 2005 as an adjunctive therapy for patients with type 2 diabetes who are not achieving blood sugar control on metformin and/or a sulfonylurea.
Key Findings: A1C reduction:* At the end of the study, patients on BYETTA experienced an average reduction in A1C of 0.8 percent from baseline compared to an increase of 0.1 percent in the control group. Of patients completing the full study, 62 percent treated with BYETTA as a combination therapy achieved an A1C of 7 percent or less, compared to approximately 16 percent in the control group.
Patients treated with BYETTA had average fasting glucose, measured before breakfast, that was 27 mg/dL lower than the control group. As measured by 7-point glucose monitoring, BYETTA significantly reduced average 2-hour post-meal glucose surges following breakfast and dinner by 34 mg/dL from baseline. 7-point glucose monitoring throughout the day demonstrated a significant reduction in average glucose concentrations in patients receiving BYETTA.
Weight change:Patients in the BYETTA arm showed an average weight reduction of 3.3 pounds compared with an average weight reduction of 0.4 pounds during treatment in the control arm. Rates of mild and moderate hypoglycemia (low blood sugar) were similar between the BYETTA and placebo treatments. No severe hypoglycemia was reported. The most common adverse event was mild to moderate nausea reported by approximately 40 percent of the patients in the BYETTA group, compared to 15 percent of patients receiving placebo.
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DID YOU KNOW:
Cost of medical care for a person with diabetes: $10,071 per year, compared with $2,669 for a person without diabetes. Diabetes In Control Dot Com: American Diabetes Association Publication date: 2002-10-24.
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