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

Paolo Pozzilli, Emanuele Bosi, Deborah Cirkel, Julia Harris, Nicola Leech, Francisco J. Tinahones, Marie Christine Vantyghem, Georgios Vlasakakis, Anette Gabriele Ziegler, Salim Janmohamed

Research output: Contribution to journalArticlepeer-review

Abstract

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 to50 mg at week 6) versus placebo together with insulin in patients with new-onset type 1diabetes 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 changefrom baseline in mixed meal tolerance test (MMTT) stimulated 2-h plasma C-peptide area underthe curve (AUC). Secondary endpoints included metabolic measures and pharmacokinetics ofalbiglutide.Results: 12/17 (70.6%, placebo) and 40/50 (80.0%, albiglutide) patients completed thestudy. Within our study, mean (standard deviation) change from baseline to week 52 inMMTT-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 studydata) 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 werereported in 82.0% (albiglutide) and 76.5% (placebo) of patients. Conclusion: In newly diagnosed patients with type 1 diabetes, albiglutide 30 to 50 mg weeklyfor 1 year had no appreciable effect on preserving residual ß-cell function versus placebo.

Original languageEnglish
JournalJournal of Clinical Endocrinology and Metabolism
Volume105
Issue number6
DOIs
Publication statusPublished - Jun 1 2020

Keywords

  • Albiglutide
  • GLP-1 receptor agonist
  • Insulin
  • Type 1 diabetes mellitus

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Biochemistry
  • Endocrinology
  • Clinical Biochemistry
  • Biochemistry, medical

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