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New diabetes drug improved glycemic control with little risk for hypoglycemia
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Compared with those assigned a placebo, approximately twice as many patients with type 2 diabetes assigned the novel agent TAK-875 achieved a target HbA1c of less than 7%, with as few as 2% experiencing hypoglycemia, recent data indicate.
TAK-875 is an oral, selective free fatty acid receptor 1 (FFAR1) agonist, also known as a G-protein-coupled receptor 40 agonist (GPR40), designed to enhance insulin secretion in a glucose-dependent manner by boosting the release of insulin from pancreatic beta cells when glucose and fatty acids rise in the blood.
In a study sponsored by Takeda Global Research and Development, Charles F. Burant, MD, of the University of Michigan Medical School, and colleagues randomly assigned 426 patients with type 2 diabetes who had not responded to diet or treatment with metformin to receive placebo, 4 mg glimepiride (Amaryl, Sanofi-Aventis) or 6.25 mg, 25 mg, 50 mg, 100 mg or 200 mg TAK-875 once daily for 12 weeks. Results were previously presented at the American Diabetes Association 71st Scientific Sessions.
At the study’s conclusion, the researchers noted significant reductions in HbA1c in the TAK-875 (ranging from –1.12% with 50 mg to –0.65% with 6.25 mg) and glimepiride (–1.05%) groups compared with the placebo group (–0.13%). Further, whereas only 19% of patients assigned placebo reached HbA1c levels less than 7%, between 33% and 48% of patients assigned TAK-875 reached this goal in 12 weeks. Results were comparable in the glimepiride group (40%).
The number of hypoglycemic events in all TAK-875 groups was significantly lower than in the glimepiride group (2% vs. 19%) and was similar to the number observed in the placebo group (3%), according to the researchers. Additionally, the overall incidence of treatment-related adverse effects was lower in the placebo and TAK-875 study arms (48% and 49%, respectively), but higher in the glimepiride arm due to the increased risk for hypoglycemia.
“In view of the frequent hypoglycemia after treatment with sulfonylureas, the low risk of hypoglycemia after treatment with TAK-875 suggests that there may be therapeutic advantage of targeting FFAR1 in treating people with type 2 diabetes,” the researchers said in a press release. “We are truly excited about the potential of TAK-875 and are eager to conduct larger trials to find out how well this drug works, how safe it is and what its place is in the treatment of diabetes.”
Despite these promising results, Clifford J. Bailey, PhD, FRCP, FRCPath, of the School of Life and Health Sciences at Aston University, Birmingham, United Kingdom, and Birmingham Children’s Hospital, said, moving forward, this class of drugs will be under scrutiny.
“On the journey to approval of a new class of treatment for type 2 diabetes, many questions will be asked of the FFAR1 agonists. Can they unlock the secretion-shy beta cells, provide durable efficacy and avoid off-target safety issues?” he wrote in an accompanying editorial. “We travel hopefully.”
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Disclosure: The study was funded by Takeda Global Research and Development. Dr. Burant is an unpaid consultant and adviser to Takeda Global Research and Development. The other researchers are employed by Takeda Global Research and Development. Dr. Bailey has consulted for or received research grants, speaker fees and travel reimbursement from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Merck Serono, Merck Sharpe & Dohme, Novo Nordisk, Prosidion and Sanofi-Aventis.
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