Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announced study results comparing treatment with BYETTA(R) (exenatide) injection with insulin glargine in people with type 2 diabetes.
Study findings showed comparable improvements in blood sugar control with BYETTA and insulin glargine therapies, with weight loss and lower incidence of hypoglycemia associated with BYETTA.
Patients in the study were also taking one of two commonly used oral medications. These findings were presented at the 67th Annual Scientific Sessions of the American Diabetes Association (ADA) in Chicago.
This open-label crossover study of 114 people with type 2 diabetes compared treatment with BYETTA (5 mcg for 4 weeks and 10 mcg for 12 weeks) and oral medication (metformin or a sulfonylurea) with treatment with insulin glargine and oral medication on measures of blood sugar control, weight change and incidence of hypoglycemia during two 16-week periods. Treatment with BYETTA resulted in blood sugar control (measured by A1C reductions) comparable to treatment with insulin glargine (-1.43 percent vs. -1.41 percent, respectively).(1)
However, BYETTA treatment with metformin resulted in statistically significant lower risk of hypoglycemia (2.6 percent) than treatment with insulin glargine and metformin (17.4 percent). Additionally, there were seven episodes of severe hypoglycemia in three patients taking insulin glargine and no severe episodes during treatment with BYETTA, reflecting a lower overall risk of hypoglycemia. BYETTA treatment was also associated with a 5.7-pound weight loss from baseline, compared with a 1.3-pound weight gain among individuals in the insulin glargine group (a 7.0-pound difference between groups).
“Adding BYETTA to oral medication to achieve target blood sugar control levels can be an important next step in the management of type 2 diabetes,” said Michael Trautmann, MD, lead investigator of this study and Medical Fellow of Eli Lilly and Company. “This study shows that adding BYETTA to oral medication before insulin use may help people with type 2 diabetes obtain the same glucose control as insulin and yet lose weight with reduced risk of hypoglycemia.”
BYETTA was generally well-tolerated in this study, and side effects were consistent with those seen in previous studies. In clinical trials and post- approval adverse event reports, the most common side effect is mild-to- moderate nausea, which affects fewer than half of patients and usually decreases over time.
BYETTA is indicated for use as an adjunctive therapy for people with type 2 diabetes who are not achieving blood sugar control using metformin, a sulfonylurea, or a thiazolidinedione. Over three million prescriptions have been written in the U.S. since being approved by the Food and Drug Administration (FDA) in 2005.