Byetta approved for use with insulin
pharmafile | October 19, 2011 | News story | | Amylin, GLP-1, diabetes, lilly
The FDA has approved the use of Lilly and Amylin’s diabetes treatment Byetta as an add-on therapy to insulin glargine.
The US regulator has approved its use with insulin with or without metformin and/or a thiazolidinedione, in conjunction with diet and exercise type II diabetes patient whose blood sugar is not controlled by insulin glargine (Sanofi’s Lantus) alone.
The decision makes Byetta the first GLP-1 receptor agonist to gain US approval for use with insulin glargine, and will help it in the highly competitive diabetes market.
“This expanded use for Byetta is important for clinical care, in that it provides a new option for the many patients with type II diabetes who are not achieving treatment goals,” said John Buse, professor of medicine, director of the Diabetes Care Center and chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill.
“Byetta is well-suited for use with insulin glargine, offering a simple fixed-dose regimen that can help improve control of blood sugar overall and after meals. In a clinical trial, patients using Byetta with insulin glargine achieved better glycaemic control, without weight gain or an increased risk of hypoglycaemia, compared to patients using insulin glargine alone.”
Patients on the trial received insulin glargine, with or without metformin and/or a thiazolidinedione, and were randomised to receive Byetta or placebo in addition to aggressive insulin titration.
After 30 weeks of treatment, A1C blood sugar levels fell by 1.7 percentage points in patients adding Byetta, compared with a 1.0 percentage point decrease in patients treated with insulin glargine alone. Nausea was the most common adverse event, and occurred in 41% of patients treated with Byetta compared with 8% of patients treated with insulin glargine alone.
Byetta was approved in 2005, and was the first-in-class GLP-1 receptor agonist on the market. Novo Nordisk’s Victoza (liraglutide) followed with launches in the EU in 2009 and the US in 2010.
The double-blind clinical trial evaluating Byetta as an add-on therapy to insulin glargine was published in Annals of Internal Medicine, and looked at 261 patients receiving insulin glargine with or without metformin and/or a TZD, randomised to receive Byetta 10 micrograms or placebo.
Patients who may have been at increased risk of hypoglycaemia (A1C≤8 percent) reduced their dose of insulin glargine by 20 percent. Five weeks after randomisation, 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, hypoglycaemia and patient-reported outcomes.
After 30 weeks of treatment, the proportion of participants achieving the target A1C≤7 percent was 60% in the Byetta group and 35% in the insulin glargine group. For the target A1C≤6.5 percent, the proportions were 40% and 12%, respectively. 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.
The greater improvement in A1C with Byetta was not accompanied by an increase in hypoglycaemia, compared to insulin glargine alone.
Thirteen exenatide recipients and one placebo recipient (9% vs. 1%) discontinued the study because of adverse events; rates of nausea (41% vs. 8%), diarrohea (18% vs. 8%), vomiting (18% vs. 4%), headache (14% vs. 4%) and constipation (10% vs. 2%) were higher with exenatide than with placebo. Hypoglycaemia was similar for both groups; major hypoglycaemia occurred twice in one patient receiving insulin glargine alone.
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