Article Dans Une Revue Journal of Clinical Endocrinology and Metabolism Année : 2020

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

Paolo Pozzilli
  • Fonction : Auteur
Emanuele Bosi
  • Fonction : Auteur
Deborah Cirkel
  • Fonction : Auteur
Julia Harris
  • Fonction : Auteur
Nicola Leech
  • Fonction : Auteur
Francisco J Tinahones
  • Fonction : Auteur
Georgios Vlasakakis
  • Fonction : Auteur
Anette-Gabriele Ziegler
  • Fonction : Auteur
Salim Janmohamed
  • Fonction : Auteur

Résumé

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.

Dates et versions

hal-04746263 , version 1 (21-10-2024)

Identifiants

Citer

Paolo Pozzilli, Emanuele Bosi, Deborah Cirkel, Julia Harris, Nicola Leech, et al.. Randomized 52-week Phase 2 Trial of Albiglutide Versus Placebo in Adult Patients With Newly Diagnosed Type 1 Diabetes.. Journal of Clinical Endocrinology and Metabolism, 2020, Journal of Clinical Endocrinology and Metabolism, 105, pp.e2192-e2206. ⟨10.1210/clinem/dgaa149⟩. ⟨hal-04746263⟩

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