Insulet Data Backs Omnipod 5 for Type 2 Diabetes, Seeks Expanded FDA OK

Insulet presented results from its Omnipod 5 automated insulin delivery (AID) system type 2 diabetes pivotal trial at the American Diabetes Association (ADA) 84th Scientific Sessions.
 
The study assessed the impact of AID in a diverse range of participants with type 2 diabetes who need insulin. SECURE-T2D results demonstrated glycemic improvements using Omnipod 5 compared to prior treatments of insulin injections or pump therapy.
 
The trial’s main objective was to evaluate change in HbA1c with Omnipod 5 in adults aged 18-75 years, living with type 2 diabetes with a current insulin regimen for at least three months. Other criteria included a baseline HbA1c between 7% and 12% for those using basal insulin only, and 12% or less for those using basal and bolus or pre-mixed insulin.
 
305 participants from 21 U.S. sites were evaluated, including 24% Black and 22% Hispanic participants. More than half (55%) were on a stable dose of GLP-1 receptor agonists, and 73% used multiple daily injections of insulin, while 21% used basal-only insulin at baseline, and only 5.6% used an insulin pump at baseline.
 
After an initial 14 days of standard therapy, the study participants used the Omnipod 5 AID system for 13 weeks. They could eat and exercise with no restrictions and were given the option to bolus for blood glucose corrections only, for actual carbohydrate intake, or for a set carbohydrate regimen.
 
Significant reductions (0.8%) were shown in mean HbA1c, lowering from 8.2% to 7.4%. Those with higher baseline HbA1c had a larger decrease. These improvements were seen regardless of prior therapy.
 
Time in range increased by 20%, or 4.8 hours per day, from 45% to 66%. Time below 54 mg/dL (%) and time below 70 mg/dL (%) were shown to be non-inferior (within a 0.5% and 2.0% margin, respectively).
 
Insulin use dropped from an average of 0.80 U/kg/day during standard therapy to 0.57 U/kg/day during AID. This corresponds to an average decrease of 23 U/day.
 
There was also a significant and clinically meaningful improvement reported in diabetes distress, according to Insulet. There were no instances of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome.
 
Insulet recently submitted these study results to the FDA to expand Omnipod 5’s indications for use for people with type 2 diabetes and, subject to FDA clearance, expects to commercially launch in the U.S. in early 2025.
 
“These data demonstrate that simple, easy-to-use AID technology, such as Omnipod 5, can be adopted by a broad population of people with type 2 diabetes and improve their lives,” said Dr. Trang Ly MBBS, FRACP, Ph.D., Insulet’s senior VP and medical director. “A major strength of this study is the diversity of the enrolled population in terms of varying education level, income, ethnicity, and race. 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.”
 
Last week, Insulet began full U.S. commercial launch of the Omnipod 5 automated insulin delivery (AID) system with Dexcom G7 continuous glucose monitor (CGM).