Titre :

Randomized 52-week Phase 2 Trial of Albiglutide Versus Placebo in Adult Patients With Newly Diagnosed Type 1 Diabetes.

Auteur(s) :

Pozzilli, Paolo [Auteur]
Bosi, Emanuele [Auteur]
Cirkel, Deborah [Auteur]
Harris, Julia [Auteur]
Leech, Nicola [Auteur]
Tinahones, Francisco J [Auteur]
Vantyghem, Marie-Christine [Auteur]
Recherche translationnelle sur le diabète (RTD) - U1190
Vlasakakis, Georgios [Auteur]
Ziegler, Anette-Gabriele [Auteur]
Janmohamed, Salim [Auteur]

Titre de la revue :

Journal of Clinical Endocrinology and Metabolism

Nom court de la revue :

J. Clin. Endocrinol. Metab.

Numéro :

105

Pagination :

e2192–e2206

Date de publication :

2020-06

ISSN :

1945-7197

Mot(s)-clé(s) en anglais :

type 1 diabetes mellitus
albiglutide
GLP-1 receptor agonist
insulin

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

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 ...
Lire la suite >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 β-cell function versus placebo.Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Recherche translationnelle sur le diabète (RTD) - U1190

Date de dépôt :

2024-01-19T23:32:43Z
2024-10-21T10:59:21Z