Dive Brief:

• Insulet is looking to expand the label for its Omnipod 5 insulin pump for people with Type 2 diabetes. The company said Friday it recently filed with the Food and Drug Administration. 
• Insulet presented study results at the American Diabetes Association’s 84th Scientific Sessions that evaluated Omnipod 5 in people with Type 2 diabetes who were taking basal insulin or multiple daily injections. The results showed “substantial improvements in blood glucose outcomes and overall quality of life,” said study chair Francisco Pasquel, an associate professor of endocrinology at Emory School of Medicine.
• Insulet’s filing comes as other diabetes technology companies look to expand their offerings for people with Type 2 diabetes. Tandem Diabetes Care has published results showing how its T:slim x2 pump with Control IQ improved time in range for people with Type 2 diabetes, and Dexcom and Abbott recently gained FDA clearance for continuous glucose monitors tailored for people with Type 2 who don’t take insulin.

Dive Insight:

Insulet wants to target the 30 million people in the U.S. who have Type 2 diabetes with the label expansion. 

Omnipod 5 is currently cleared in the U.S. for people with Type 1 diabetes. Insulet hopes to expand the pump to people with Type 2 diabetes, with an expected launch in early 2025. 

The FDA has not yet cleared any automated insulin delivery systems for people with Type 2 diabetes, Insulet said. The company has a basal-only insulin pump, called Omnipod Go, that was cleared for people with Type 2 diabetes last year, but it does not connect to other devices. 

Insulet studied Omnipod 5 in 305 people across 21 sites. The majority (73%) were taking multiple daily injections of insulin, 21% were taking basal insulin only and nearly 6% had been using an insulin pump. After 14 days of this standard therapy, they used Insulet’s Omnipod 5 insulin pump for 13 weeks.

The participants’ mean HbA1c, the study’s primary endpoint, decreased from 8.2% to 7.4%. Time in range, which shows how long a user stays in their target blood glucose range during the day, increased from 45% to 66%, equal to nearly five hours per day. The study also showed reductions in total daily insulin dose and time in hyperglycemia and a clinically meaningful improvement in diabetes distress.  

The results were “in line with, and several metrics better than, smaller real-world and early-stage data sets previously presented,” William Blair analyst Margaret Kaczor Andrew wrote in a research note on Monday.

A strength of the study was the diversity of enrollment, Insulet Medical Director Trang Ly said. About 24% of participants were Black and 22% were Hispanic. 

“These results could have a particularly striking impact among Black and Hispanic people, who experience a higher prevalence of [Type] 2 diabetes and increased mortality rates,” Ly said. 

Even though Omnipod 5 is not currently indicated for Type 2 diabetes, doctors prescribe it for their patients with full reimbursement since the pharmacy channel doesn’t distinguish between Type 1 or Type 2 patients, J.P. Morgan analyst Robbie Marcus wrote in a research note on Sunday. 

“However, we think the bulk of acceleration will come from the fully approved label expansion when Insulet is able to aggressively market the product at the sub-specialty practice level starting early next year,” Marcus said, adding that use of Omnipod in Type 2 patients will likely remain high given the pump’s ease of use and simple learning curve.