Novo Nordisk’s weekly combined basal insulin Icodec and semaglutide product (IcoSema) was not inferior to daily injected insulin glargine U100 plus aspart in lowering A1c levels in people with type 2 diabetes, according to topline study data released by the company.
In the 52-week open-label, randomized clinical trial COMBINE 3 Phase 3a data, the once-weekly IcoSema injection was non-inferior to separate injections of once-daily mealtime insulin glargine U100 and insulin aspart. The study included 679 people with type 2 diabetes with average A1c levels of 8.3% who were receiving daily basal insulin and some also taking oral antidiabetic medications.
After 52 weeks, A1c reductions were 1.47 with IcoSema compared to 1.40 with daily glargine and aspart, meeting the primary non-inferiority endpoint. Participants taking IcoSema experienced a weight loss of 3.6 kg compared to a weight gain of 3.2 kg with the two insulins, based on a starting body weight of 85.8 kg.
The rates of clinically significant hypoglycemia, defined as events below 3.0 mmol/l (54 mg/dl) per patient-year of exposure, were 0.26 with once-weekly IcoSema versus 2.18 with daily glargine + aspart. The gastrointestinal side effects were consistent with those of the glucagon-like peptide-1 agonist class and were mostly mild to moderate, the company reported.
These COMBINE 3 data are the first to be released from the multicenter, multinational Phase 3a COMBINE study program. COMBINE 1, a 52-week study comparing once-weekly IcoSema with insulin icodec in approximately 1300 patients, and COMBINE 2, which compares IcoSema with semaglutide in about 700 patients, will be released later this year.
Miriam E. Tucker is a freelance journalist based in the Washington, DC area. She regularly contributes to Medscape Medical News, with additional work appearing in The Washington Post, NPR’s Shots blog, and Diabetes Forecast Magazine. She is on X (formerly known as Twitter) at: @MiriamETucker.