Randomized 52-week phase 2 trial of albiglutide versus placebo in adult patients with newly diagnosed type 1 diabetes
Open accessAbstract
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.
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Only two randomized controlled trials assessed GLP-1RA discontinuation in type 1 diabetes.
“Notably, only two RCTs assessed GLP-1RA discontinuation in type 1 diabetes.24,25”
From Metabolic rebound after GLP-1 receptor agonist discontinuation: a systematic review and meta-analysis (2025) · cites this paper as [25]
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- Authors
- Pozzilli, P., Bosi, E., Cirkel, D., Harris, J., Leech, N., Tinahones, F. J., Vantyghem, M.-C., Vlasakakis, G., Ziegler, A.-G., & Janmohamed, S.
- Affiliations
- Università Campus Bio-Medico (IT)
- Vita-Salute San Raffaele University (IT)
- GlaxoSmithKline (United Kingdom) (GB)
- Newcastle upon Tyne Hospitals NHS Foundation Trust (GB)
- Instituto de Salud Carlos III (ES)
- Inserm (FR)
- TUM Klinikum (DE)
- Corresponding author
- Pozzilli, Paolo
- ORCID
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2020-03-27
- Volume
- 105
- Issue
- 6
- Pages
- e2192-e2206
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W3013558293
- Cited by
- 45
- References
- 25
- Citations by year
- 2026: 8 · 2025: 10 · 2024: 2 · 2023: 10 · 2022: 6 · 2021: 6 · 2020: 3
- FWCI
- 4.71
- Type
- journal article
- Language
- en
- Open access
- green
- hdl.handle.net
- Licence
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed (publishedVersion)
- RISalud Institutional Health Repository of Andalucía (submittedVersion, other-oa)
- HAL (submittedVersion)
- mediaTUM (Technical University of Munich) (submittedVersion)
- Site cant be reached (submittedVersion, other-oa)
- PuSH - Publication Server of Helmholtz Zentrum München (submittedVersion)
- Funders
- GlaxoSmithKline
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Keywords
- albiglutide, type 1 diabetes, GLP-1 receptor agonists, residual beta-cell function, C-peptide, newly diagnosed diabetes, insulin therapy, pharmacokinetics, adverse events
- MeSH terms
- Adolescent, Adult, Blood Glucose, Diabetes Mellitus, Type 1, Female, Follow-Up Studies, Humans, Male, Prognosis, Biomarkers, Glucagon-Like Peptide 1, Incretins, Young Adult
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