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Pozzilli, P.* ; Bosi, E.* ; Cirkel, D.* ; Harris, J.* ; Leech, N.* ; Tinahones, F.J.* ; Vantyghem, M.C.* ; Vlasakakis, G.* ; Ziegler, A.-G. ; Janmohamed, S.*

Randomized 52-week phase 2 trial of albiglutide vs placebo in adult patients with newly diagnosed type 1 diabetes.

J. Clin. Endocrinol. Metab. 105, e2192–e2206 (2020)
Verlagsversion Postprint DOI
Open Access Green
Context: GLP-1 receptor agonists are an established therapy in patients with type 2 diabetes; however, their role in type 1 diabetes remains to be determined.Objective: 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.Design: 52-week, randomized, phase 2 study (NCT02284009).Methods: 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.Results: 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.Conclusion: In newly diagnosed patients with type 1 diabetes, albiglutide 30 to 50 mg weekly for 1 year had no appreciable effect on preserving residual beta-cell function versus placebo.
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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Schlagwörter Type 1 Diabetes Mellitus ; Albiglutide ; Glp-1 Receptor Agonist ; Insulin; Anti-cd3 Monoclonal-antibody; Beta-cell Function; Insulin-treatment; C-peptide; Efficacy; Safety; Onset; Preservation; Liraglutide; Association
ISSN (print) / ISBN 0021-972X
e-ISSN 1945-7197
Quellenangaben Band: 105, Heft: 6, Seiten: e2192–e2206 Artikelnummer: , Supplement: ,
Verlag Endocrine Society
Verlagsort Bethesda, Md.
Begutachtungsstatus Peer reviewed