Amylin (AMLN), Lilly (LLY) Get FDA Approval for BYETTA Use as Add-On to Insulin in Certain Cases
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Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved a new use for BYETTA (exenatide) injection. BYETTA is now approved as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione (TZD), in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone.
In the study supporting the expanded use, patients receiving insulin glargine, with or without metformin and/or a TZD, were randomized to receive BYETTA or placebo in addition to aggressive insulin titration. After 30 weeks of treatment, A1C decreased by 1.7 percentage points in patients adding BYETTA, compared with a decrease of 1.0 percentage point in patients treated with insulin glargine alone (p<0.001). A1C is a measure of average blood sugar over three months. Nausea, which was the most common adverse event, occurred in 41 percent of patients treated with BYETTA compared with 8 percent of patients treated with insulin glargine alone.
The double-blind clinical trial evaluating BYETTA as an add-on therapy to insulin glargine was published in Annals of Internal Medicine.(i) In the study, 261 patients receiving insulin glargine with or without metformin and/or a TZD were randomized to receive BYETTA 10 micrograms or placebo. Patients who may have been at increased risk of hypoglycemia (A1C≤8 percent) reduced their dose of insulin glargine by 20 percent. Five weeks after randomization, all patients had insulin doses aggressively titrated to target fasting blood glucose. The primary endpoint was reduction in A1C; secondary endpoints included change in body weight along with other parameters of glucose control, cardiovascular health, hypoglycemia and patient-reported outcomes.
After 30 weeks of treatment, the proportion of participants achieving the target A1C≤7 percent was 60 percent in the BYETTA group and 35 percent in the insulin glargine group (p<0.001). For the target A1C≤6.5 percent, the proportions were 40 percent and 12 percent, respectively (p<0.001). Both groups showed lower fasting plasma glucose concentrations; however, after morning and evening meals, when BYETTA was administered, postprandial glucose control was significantly improved in patients treated with BYETTA, compared to placebo. On average, weight decreased by 4 pounds in patients adding BYETTA, compared with an increase of 2 pounds in patients treated with insulin glargine alone (p<0.001). (BYETTA is not a weight-loss product.) The greater improvement in A1C with BYETTA was not accompanied by an increase in hypoglycemia, compared to insulin glargine alone.
Thirteen exenatide recipients and one placebo recipient (9 percent vs. 1 percent) discontinued the study because of adverse events (p<0.010); rates of nausea (41 percent vs. 8 percent), diarrhea (18 percent vs. 8 percent), vomiting (18 percent vs. 4 percent), headache (14 percent vs. 4 percent) and constipation (10 percent vs. 2 percent) were higher with exenatide than with placebo. Hypoglycemia was similar for both groups; major hypoglycemia occurred twice in one patient receiving insulin glargine alone.
In the study supporting the expanded use, patients receiving insulin glargine, with or without metformin and/or a TZD, were randomized to receive BYETTA or placebo in addition to aggressive insulin titration. After 30 weeks of treatment, A1C decreased by 1.7 percentage points in patients adding BYETTA, compared with a decrease of 1.0 percentage point in patients treated with insulin glargine alone (p<0.001). A1C is a measure of average blood sugar over three months. Nausea, which was the most common adverse event, occurred in 41 percent of patients treated with BYETTA compared with 8 percent of patients treated with insulin glargine alone.
The double-blind clinical trial evaluating BYETTA as an add-on therapy to insulin glargine was published in Annals of Internal Medicine.(i) In the study, 261 patients receiving insulin glargine with or without metformin and/or a TZD were randomized to receive BYETTA 10 micrograms or placebo. Patients who may have been at increased risk of hypoglycemia (A1C≤8 percent) reduced their dose of insulin glargine by 20 percent. Five weeks after randomization, all patients had insulin doses aggressively titrated to target fasting blood glucose. The primary endpoint was reduction in A1C; secondary endpoints included change in body weight along with other parameters of glucose control, cardiovascular health, hypoglycemia and patient-reported outcomes.
After 30 weeks of treatment, the proportion of participants achieving the target A1C≤7 percent was 60 percent in the BYETTA group and 35 percent in the insulin glargine group (p<0.001). For the target A1C≤6.5 percent, the proportions were 40 percent and 12 percent, respectively (p<0.001). Both groups showed lower fasting plasma glucose concentrations; however, after morning and evening meals, when BYETTA was administered, postprandial glucose control was significantly improved in patients treated with BYETTA, compared to placebo. On average, weight decreased by 4 pounds in patients adding BYETTA, compared with an increase of 2 pounds in patients treated with insulin glargine alone (p<0.001). (BYETTA is not a weight-loss product.) The greater improvement in A1C with BYETTA was not accompanied by an increase in hypoglycemia, compared to insulin glargine alone.
Thirteen exenatide recipients and one placebo recipient (9 percent vs. 1 percent) discontinued the study because of adverse events (p<0.010); rates of nausea (41 percent vs. 8 percent), diarrhea (18 percent vs. 8 percent), vomiting (18 percent vs. 4 percent), headache (14 percent vs. 4 percent) and constipation (10 percent vs. 2 percent) were higher with exenatide than with placebo. Hypoglycemia was similar for both groups; major hypoglycemia occurred twice in one patient receiving insulin glargine alone.
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