Scott Buzby , 2025-06-23 21:42:00
Key takeaways:
- Semaglutide improved time in glycemic range in patients with type 1 diabetes and obesity using an automated insulin delivery system.
- The GLP-1 also reduced body weight and maintained low hypoglycemia rates.
CHICAGO — Semaglutide improved time spent in glycemic range, time below rate and reduced body weight with low rates of hypoglycemia compared with placebo in patients with type 1 diabetes and obesity using an automated insulin delivery system.
Viral N. Shah, MD, professor of medicine in the division of endocrinology and metabolism and director of diabetes clinical research at Indiana University Center for Diabetes and Metabolic Diseases, presented results of the ADJUST-T1D trial at the American Diabetes Association Scientific Sessions that were simultaneously published in NEJM Evidence.
Adults with type 1 diabetes had a greater reduction in HbA1c and improvement in time in range with semaglutide than placebo. Image: Adobe Stock
ADJUST-T1D enrolled 72 adults with type 1 diabetes for at least 1 year who were using an automated insulin delivery system (Medtronic 770G; Tandem Control IQ; Omnipod 5 [Insulet Corp.]) for at least 3 months. Baseline HbA1c was 7% to 10% and BMI was 30 kg/m2 or higher. Participants were randomly assigned to also receive semaglutide (Ozempic, Novo Nordisk) or placebo.
Viral N. Shah
The trial featured a dose titration period of 0.25 mg semaglutide or placebo for 4 weeks, followed by 0.5 mg, after which participants continued at 1 mg for the rest of the clinical trial period, which ended at 26 weeks. The trial was fully concluded after a 2-week safety period, during which participants transitioned back to their pretrial automated insulin delivery system settings.
The average age of participants was approximately 40 years and more than half were women. The average diabetes duration among trial participants was around 22 years.
The primary composite endpoint comprised at least 70% of continuous glucose monitoring-based time between 70 mg/dL and 180 mg/dL of 70%, less than 4% of time spent below 70 mg/dL and 5% or greater reduction in body weight.
At 26 weeks, 36% of participants assigned to semaglutide met all three components of the primary composite outcome compared with none of the placebo group (P < .001), according to the results.
Participants in the semaglutide group also had a greater mean change from baseline in HbA1c compared with placebo (adjusted group difference, –0.3%; 95% CI, –0.6 to –0.05).
Participants assigned semaglutide spent nearly 9% more time in range vs. placebo (8.8%; 95% CI, 3.9-13.7), according to the presentation.
At baseline, the mean body weight of those assigned to semaglutide was 99 kg vs. 104 kg in the placebo group. Those assigned semaglutide experienced greater average weight loss vs. placebo (adjusted group difference, –8.8 kg; 95% CI, –10.6 to –7).
“We wanted to make sure that we are taking care of both glycemia as well as weight in these individuals,” Shah said during the press conference.
In an exploratory analysis, Shah and colleagues reported a 30% reduction in insulin dose by week 26 among those assigned semaglutide vs. placebo, which remained significant after adjusting for weight loss during the trial.
Overall, 53% of participants assigned semaglutide experienced gastrointestinal events vs. 25% of the placebo group. One serious adverse event occurred in the semaglutide group during the first injection; however, the patient continued in the trial.
“Semaglutide, in people with type 1 diabetes with a BMI of more than 30 kg/m2, was found to be very effective in improving time in range, reducing body weight and it appears to be safe and durable. Discontinuation was only in two participants out of 36 … which is very similar to other high-dose semaglutide and obesity trials,” Shah said during the press conference.
Reference:
Sources/Disclosures
Collapse
Shah VN, et al. Symposium – ADJUnct semaglutide treatment in type 1 diabetes (ADJUST-T1D) trial outcomes. Presented at: American Diabetes Association’s Scientific Sessions; June 20-23, 2025; Chicago.
Disclosures:
The ADJUST-T1D trial was funded by Breakthrough T1D. The study drug was provided by Novo Nordisk under an NNI investigator-initiated studies program. Shah reports consulting for Dexcom, Genomelink, Insulet Corp., Lilly Diabetes and Lumosfit; serving on advisory panels for Ascensia Diabetes Care, Embecta, Novo Nordisk, Sanofi, Tandem Diabetes Care; and receiving research support from Enable Bioscience.
