AstraZeneca's Bydureon BCise Demonstrates Positive Phase 3 Results in Pediatric and Adolescent Patients with Type 2 Diabetes

Compiled & Translated | newborn

In the GLP-1 receptor agonist (GLP-1RA) segment of the type 2 diabetes market, AstraZeneca's market position has been steadily declining. Due to intense competitive pressure from later entrants such as Eli Lilly/Boehringer Ingelheim's Trulicity (dulaglutide), Novo Nordisk's Victoza (liraglutide), and Ozempic (semaglutide), sales of AstraZeneca's two exenatide products, Byetta and Bydureon, have continued to decline.

Sixteen years after the market launch of exenatide, its long-acting sustained-release formulation, Bydureon BCise, became the first once-weekly GLP-1RA to complete a Phase 3 clinical trial in pediatric and adolescent patients with type 2 diabetes.

Recently, at the opening day of the 81st Scientific Sessions of the American Diabetes Association (ADA), AstraZeneca presented robust Phase 3 clinical trial results, which the company hopes will pave the way for an FDA submission by the end of this year.

Many consider type 2 diabetes an adult-onset disease. However, the number of younger patients continues to rise. Trials with Bydureon demonstrate that in younger patients with type 2 diabetes, 24 weeks of treatment with this medication effectively lowers blood glucose levels.

The primary method physicians use to diagnose type 2 diabetes is measuring glycated hemoglobin (A1C), which reflects blood glucose levels. Currently, the A1C threshold for diagnosing type 2 diabetes is 6.5%. An A1C level ≥6.5% indicates type 2 diabetes. In clinical trials, pediatric and adolescent patients treated with Bydureon demonstrated a 0.85% reduction in A1C levels compared to those in the placebo group.

Data presented at the ADA meeting showed that: after 24 weeks of treatment, A1C levels decreased by 0.36% in the Bydureon treatment group, while they increased by 0.49% in the placebo group. This represents a substantial difference, as the patients enrolled in the trial were still receiving concomitant metformin and insulin therapy, underscoring the aggressiveness of the disease in this patient population.

Additionally, a modest difference was observed in weight change, with patients in the Bydureon treatment group experiencing a mean weight loss of 0.59 kg (1.3 lb), compared to a mean weight gain of 0.63 kg (1.4 lb) in the placebo group.

In 2005, when Byetta's original manufacturer, Amylin, launched the drug to market, physicians were excited about the benefits brought by the first GLP-1RA. Since then, however, the drug has undergone two changes in administration procedures and three changes in delivery methods.

Exenatide’s first product, Byetta, was launched in April 2005 and requires twice-daily injections. In January 2012, Bydureon was introduced as the first once-weekly GLP-1 receptor agonist (GLP-1RA). However, its administration was inconvenient, as the drug powder required reconstitution with the supplied diluent to prepare an injectable suspension prior to use. Subsequently, under AstraZeneca’s leadership, a Bydureon injection pen was launched; however, this specific device has since been withdrawn from the market. Currently, Bydureon is administered to patients using a more convenient auto-injector pen.

Source: ADA 2021: AstraZeneca touts Bydureon trial win in children and adolescents with type 2 diabetes