Pozzilli, PaoloBosi, EmanueleCirkel, DeborahHarris, JuliaLeech, NicolaTinahones, Francisco JVantyghem, Marie-ChristineVlasakakis, GeorgiosZiegler, Anette-GabrieleJanmohamed, Salim2023-02-082023-02-082020-03-24Pozzilli P, Bosi E, Cirkel D, Harris J, Leech N, Tinahones FJ, et al. Randomized 52-week Phase 2 Trial of Albiglutide Versus Placebo in Adult Patients With Newly Diagnosed Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Jun 1;105(6):dgaa149http://hdl.handle.net/10668/15294GLP-1 receptor agonists are an established therapy in patients with type 2 diabetes; however, their role in type 1 diabetes remains to be determined. Determine efficacy and safety of once-weekly albiglutide 30 mg (up-titration to 50 mg at week 6) versus placebo together with insulin in patients with new-onset type 1 diabetes and residual insulin production. 52-week, randomized, phase 2 study (NCT02284009). A prespecified Bayesian approach, incorporating placebo data from a prior study, allowed for 3:1 (albiglutide:placebo) randomization. The primary endpoint was 52-week change from baseline in mixed meal tolerance test (MMTT) stimulated 2-h plasma C-peptide area under the curve (AUC). Secondary endpoints included metabolic measures and pharmacokinetics of albiglutide. 12/17 (70.6%, placebo) and 40/50 (80.0%, albiglutide) patients completed the study. Within our study, mean (standard deviation) change from baseline to week 52 in MMTT-stimulated 2-h plasma C-peptide AUC was -0.16 nmol/L (0.366) with placebo and -0.13 nmol/L (0.244) with albiglutide. For the primary Bayesian analysis (including prior study data) the posterior treatment difference (95% credible interval) was estimated at 0.12 nmol/L (0-0.24); the probability of a difference ≥0.2 nmol/L between treatments was low (0.097). A transient significant difference in maximum C-peptide was seen at week 28. Otherwise, no significant secondary endpoint differences were noted. On-therapy adverse events were reported in 82.0% (albiglutide) and 76.5% (placebo) of patients. In newly diagnosed patients with type 1 diabetes, albiglutide 30 to 50 mg weekly for 1 year had no appreciable effect on preserving residual β-cell function versus placebo.enGLP-1 receptor agonistalbiglutideinsulintype 1 diabetes mellitusAdolescentAdultBiomarkersBlood GlucoseDiabetes Mellitus, Type 1FemaleFollow-Up StudiesGlucagon-Like Peptide 1HumansIncretinsMalePrognosisYoung Adultresearch article32219329open accessBiomarcadoresDiabetes mellitus tipo 1Estudios de seguimientoGlucemiaIncretinasPéptido 1 similar al glucagón10.1210/clinem/dgaa1491945-7197https://academic.oup.com/jcem/article-pdf/105/6/e2192/41829538/jcem_105_6_e2192.pdf