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Cited by 63Diabetes Management and ResearchDiabetes Treatment and ManagementDiabetes and associated disorders

Semaglutide in Adults with Type 1 Diabetes and Obesity

Shah, Viral N., Akturk, Halis K., Kruger, Davida, Ahmann, Andrew, Bhargava, Anuj, Bakoyannis, Giorgos, Pyle, Laura, Snell-Bergeon, Janet K.·2025·NEJM Evidence
DOI 10.1056/evidoa2500173
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Abstract

BACKGROUND: Once-weekly semaglutide is approved for the management of type 2 diabetes and obesity. The efficacy and safety of semaglutide in adults with type 1 diabetes are not established. METHODS: In this 26-week, double-blind trial, we randomly assigned 72 adults with type 1 diabetes using an automated insulin delivery (AID) system and with a body mass index of 30 or higher in a 1:1 ratio to receive once-weekly semaglutide up to 1 mg or placebo. The primary composite end point consisted of achieving all of the following elements: continuous glucose monitoring (CGM)-based time between 70 and 180 mg/dl of greater than 70% and time below 70 mg/dl of less than 4%; and weight reduction of at least 5%. RESULTS: A significantly greater percentage of patients in the semaglutide group than in the placebo group achieved the primary composite outcome (36% vs. 0%; between-group difference, 36 percentage points; 95% confidence interval [CI], 20.6 to 52.2; P<0.001). The difference in the least-squares mean change from baseline to week 26 for the semaglutide versus placebo group for glycated hemoglobin was -0.3 percentage points (95% CI, -0.6 to -0.05), for percentage of time with CGM glucose levels between 70 and 180 mg/dl it was 8.8 percentage points (95% CI, 3.9 to 13.7), and for body weight it was -8.8 kg (95% CI, -10.6 to -7.0). There were two severe hypoglycemia events in each group, and no diabetic ketoacidosis was reported. CONCLUSIONS: In adults with type 1 diabetes and obesity, semaglutide treatment, compared with AID use alone, significantly improved achievement of a composite of time in range of greater than 70%, with time below range of less than 4%, and a 5% body weight reduction. (Funded by Breakthrough T1D [Type 1 Diabetes]; ADJUST-T1D trial ; Clinicaltrials.gov number, NCT05537233).

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Authors
Shah, V. N., Akturk, H. K., Kruger, D., Ahmann, A., Bhargava, A., Bakoyannis, G., Pyle, L., & Snell-Bergeon, J. K.
Affiliations
  • Indiana University Indianapolis (US)
  • Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora
  • Henry Ford Health (US)
  • Oregon Health & Science University (US)
  • Iowa Diabetes Research, Des Moines
  • University of Washington (US)
ORCID
Venue
NEJM Evidence
Publisher
Massachusetts Medical Society
Published
2025-07-22
Volume
4
Issue
8
Pages
EVIDoa2500173-EVIDoa2500173
ISSN
2766-5526 (ISSN-L)
DOI
10.1056/evidoa2500173
OpenAlex
W4411548687
Cited by
62
References
26
Citations by year
2026: 48 · 2025: 14
FWCI
42.28
Type
journal article
Language
en
Open access
closed
Locations
  • NEJM Evidence (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
Keywords
semaglutide, type 1 diabetes, obesity, GLP-1 receptor agonists, artificial pancreas, continuous glucose monitoring, time in range, hypoglycemia, weight loss, HbA1c, diabetic ketoacidosis
MeSH terms
Semaglutide, Adult, Blood Glucose, Diabetes Mellitus, Type 1, Double-Blind Method, Glucagon-Like Peptides, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Male, Middle Aged, Obesity, Weight Loss, Body Mass Index, Treatment Outcome, Glucagon-Like Peptide 1

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