Study wrapper · #413
Efficacy and Safety of Intensifying Once-Weekly Insulin Icodec Treatment With Once-Weekly Semaglutide in Adults With Type 2 Diabetes: A Single-Arm, Open-Label, Treat-to-Target, Phase 3b Trial (ONWARDS 8).
Editor's note
This is a Phase 3b interventional trial (ONWARDS 8), but it is single-arm and open-label — there is no control group and no randomization, so results cannot be attributed to semaglutide against a comparator. In 148 adults with type 2 diabetes on weekly insulin icodec, 94 added weekly semaglutide (up to 1.0 mg) for a 26-week intensification phase. Researchers reported HbA1c fell by an estimated 1.23 percentage points (from 7.88% to 6.66%) from week 26 to 52, with improvements in self-measured and post-meal glucose, a 3.85 kg weight reduction, a 24% reduction in weekly insulin dose, and a low rate of clinically significant or severe hypoglycemia (0.24 events per person-year). The magnitude is meaningful and consistent with semaglutide's known glucose and weight effects, but the single-arm design, open-label knowledge, modest size and estimated endpoints limit inference. Read as supportive feasibility data for combining semaglutide with weekly insulin, not a controlled efficacy result.
Plain-language abstract
This trial tested whether adding weekly semaglutide to a weekly insulin (icodec) helps adults with type 2 diabetes whose blood sugar is not well controlled. It was a single-group study — everyone received the same treatment, with no comparison group. After a 26-week period on insulin alone, 94 of 148 participants added semaglutide for another 26 weeks. Average long-term blood sugar (HbA1c) dropped by about 1.2 percentage points, blood sugar readings including after meals improved, participants lost about 3.85 kg, and the amount of insulin needed fell by roughly a quarter. Serious low-blood-sugar episodes were uncommon. The researchers concluded the combination was feasible and generally well tolerated in this group. Because there was no comparison group and everyone knew what they were taking, the study cannot prove the improvements were due to semaglutide alone, and the number of participants was modest. Larger controlled studies would strengthen the findings.