Liraglutide enhances insulin secretion and prolongs the remission period in adults with newly diagnosed type 1 diabetes (the NewLira study): A randomized, double‐blind, placebo‐controlled trial

• Published in: Diabetes, obesity & metabolism Vol. 26; no. 11; pp. 4905 - 4915
• Main Authors: Dejgaard, Thomas F., Frandsen, Christian S., Kielgast, Urd, Størling, Joachim, Overgaard, Anne J., Svane, Maria S., Olsen, Markus Harboe, Thorsteinsson, Birger, Andersen, Henrik U., Krarup, Thure, Holst, Jens J., Madsbad, Sten
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-11-2024; Wiley Subscription Services, Inc
• Subjects: beta‐cell function; clinical trial; Diabetes; Diabetes mellitus (insulin dependent); GLP‐1 analogue; Glucagon; glycaemic control; Hypoglycemia; incretin therapy; Insulin; Insulin secretion; Peptides; Placebos; Remission; type 1 diabetes; clinical trial; type 1 diabetes; GLP‐1 analogue; remission; beta‐cell function; glycaemic control; incretin therapy
• ISSN: 1462-8902; 1463-1326; 1463-1326
• DOI: 10.1111/dom.15889

Aim
To test the effect of the glucagon‐like peptide‐1 receptor agonist, liraglutide, on residual beta‐cell function in adults with newly diagnosed type 1 diabetes.
Materials and Methods
In a multicentre, double‐blind, parallel‐group trial, adults with newly diagnosed type 1 diabetes and stimulated C‐peptide of more than 0.2 nmol/L were randomized (1:1) to 1.8‐mg liraglutide (Victoza) or placebo once daily for 52 weeks with 6 weeks of follow‐up with only insulin treatment. The primary endpoint was the between‐group difference in C‐peptide area under the curve (AUC) following a liquid mixed‐meal test after 52 weeks of treatment.
Results
Sixty‐eight individuals were randomized. After 52 weeks, the 4‐hour AUC C‐peptide response was maintained with liraglutide, but decreased with placebo (P = .002). Six weeks after end‐of‐treatment, C‐peptide AUCs were similar for liraglutide and placebo. The average required total daily insulin dose decreased from 0.30 to 0.23 units/kg/day with liraglutide, but increased from 0.29 to 0.43 units/kg/day in the placebo group at week 52 (P < .001). Time without the need for insulin treatment was observed in 13 versus two patients and lasted for 22 weeks (from 3 to 52 weeks) versus 6 weeks (from 4 to 8 weeks) on average for liraglutide and placebo, respectively. Patients treated with liraglutide had fewer episodes of hypoglycaemia compared with placebo‐treated patients. The adverse events with liraglutide were predominantly gastrointestinal and transient.
Conclusions
Treatment with liraglutide improves residual beta‐cell function and reduces the dose of insulin during the first year after diagnosis. Beta‐cell function was similar at 6 weeks postliraglutide treatment.