Amylin Submits First GLP-1/Basal Insulin Combination to the FDA
Although the GLP-1 agonist drug class (like Byetta and Victoza) and basal insulins (like Lantus and Levemir) have been around for some time, only recently have the two drugs been examined as a combination therapy for type 2 diabetes. We know from our advisory team and all the talks we have attended over the past several years that GLP-1/basal insulin combination therapies make a lot of sense for several reasons: 1) GLP-1s reduce food intake (they make you less hungry! – this is often termed “increasing satiety”) and promote weight loss, so they can counteract the weight gain often observed with basal insulin therapy; and 2) GLP-1s and basal insulins work in complementary ways to control glucose levels – basal insulins act over a long interval and at a slow rate to cover background insulin needs while GLP-1 agonists only stimulate insulin secretion when blood glucose levels are high, allowing for improved glycemic control after meals without increasing the risk for hypoglycemia (for more on how GLP-1 agonists work, please see our Learning Curve column in diaTribe issue #1). As was discussed in diaTribe issue #24’s New Now Next column, a study examining Byetta in combination with Lantus confirmed much of this thinking, as type 2 patients achieved a greater reduction in A1c and weight loss (instead of weight gain) on both therapies than on Lantus alone. We have also learned from conversations with healthcare providers that--although not approved by the FDA or other regulatory agencies, not promoted by companies, and not covered by many insurance companies--this combination is still quite commonly prescribed today.
As such, following these results, Amylin Pharmaceuticals and Eli Lilly, the maker of Byetta, filed an application with the FDA in late December 2010 asking the agency to approve the use of Byetta as an add-on to basal insulin therapy for type 2 patients. Usually, the FDA takes around 10 months to review such applications, placing possible approval in October 2011. We’re excited by this development because if the combination is approved, Byetta could become an attractive (and reimbursable) option for many who do not want to take “mealtime insulin” to control post-meal glucose levels.
With the success of the Byetta trial above, other companies have also begun investigating additional GLP-1/basal insulin combinations. Novo Nordisk is conducting clinical trials for its GLP-1 agonist Victoza in combination with its long-acting analog insulin Levemir, and plans to begin trials later this year to combine Victoza and Degludec, the company’s ultra-long acting insulin that is now in phase 3 trials. Meanwhile, sanofi-aventis is finalizing plans for trials for its own candidate GLP-1 agonist lixisenatide with Lantus. Unlike for Byetta, the Victoza/Degludec and lixisenatide/Lantus combinations will be dosed using a single pen, reducing the number of injections needed. Both of t
