RT Journal Article
T1 Randomized 52-week Phase 2 Trial of Albiglutide Versus Placebo in Adult Patients With Newly Diagnosed Type 1 Diabetes.
A1 Pozzilli, Paolo
A1 Bosi, Emanuele
A1 Cirkel, Deborah
A1 Harris, Julia
A1 Leech, Nicola
A1 Tinahones, Francisco J
A1 Vantyghem, Marie-Christine
A1 Vlasakakis, Georgios
A1 Ziegler, Anette-Gabriele
A1 Janmohamed, Salim
K1 GLP-1 receptor agonist
K1 albiglutide
K1 insulin
K1 type 1 diabetes mellitus
AB 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. 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.
PB Oxford University Press
YR 2020
FD 2020-03-24
LK http://hdl.handle.net/10668/15294
UL http://hdl.handle.net/10668/15294
LA en
NO Pozzilli 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):dgaa149
NO Financial Support: Funding for this study (NCT02284009 available from www.clinicaltrials.gov) was provided by GlaxoSmithKline.
DS RISalud
RD Apr 6, 2025