Authors: Viral N. Shah, M.D., Halis K. Akturk, M.D., Davida Kruger, N.P., Andrew Ahmann, M.D., Anuj Bhargava, M.D., Giorgos Bakoyannis, Ph.D., Laura Pyle, Ph.D., and Janet K. Snell-Bergeon, Ph.D.

 

Published June 23, 2025

NEJM Evid 2025;4(8)

DOI: 10.1056/EVIDoa2500173

 

 

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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Studien diskuteras i Dagens Medicin 20/8 liksom i fet stil på framsidan av tidningen, Semiglutide gav resultat vid typ 1 diabetes”

 

 

Prof Mona Landin-Olsson, Lund tar upp kortfattat i artikeln av journalist Malin Pääjärvi

• tidigare finns små men ofta ej randomiserade studier med läkemedlet vid typ 1 diabetes

• det är en liten men välgjord studie med 72 patienter följda under 26 v, dubbel blint, RCT

• den visar en klar spositiv killnad, signifikant

• det finns en rädsla för DKA men i studien hade alla patienter BMI över 30, bra grupp, har högre insulindoser med mindre risk för ketoacidos

• de vanligaste biverkningarna var gastrointestinala, 57 fall i behandlingsgruppen, 13 i placebogruppen

• relativt kort uppföljningstid och litet antal patienter – allvarligare biverkningar kan därför ha missats

• studien utfördes på 4 centra i USA och finansierades av  icke-vinstgivande organisation

 

 

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