Albiglutide 30mg powder and solvent for solution for injection pre-filled disposable devices

Background: No meta-analysis has holistically analyzed and summarized the therapeutic efficacy and safety of albiglutide in type 2 diabetes (T2D). This meta-analysis addresses this knowledge gap. Methods: Randomized controlled trials involving patients with T2D receiving albiglutide in the intervention arm and either a placebo or an active comparator in the control arm were searched through electronic databases. The primary outcome was the change from baseline (CFB) in glycated hemoglobin (HbA1c); secondary outcomes included CFB in fasting plasma glucose, body weight, and adverse events (AE). Results: From 443 initially screened articles, data from 12 randomized controlled trials involving 6423 subjects were analyzed. Albiglutide, at both doses, outperformed placebo in terms of HbA1c reductions (for albiglutide 30 mg: mean differences −1.04%, 95% confidence interval [CI] [−1.37–−0.72], P < .00001, I 2 = 89%; and for albiglutide 50 mg: mean differences −1.10%, 95% CI [−1.45–−0.75], P < .00001, I 2 = 90%). Higher proportions of subjects achieved HbA1c < 7% in the albiglutide arm than in placebo (for albiglutide 30 mg: odds ratio 6.26, 95% CI [2.50–15.70], P < .0001, I 2 = 82%; and for albiglutide 50 mg: odds ratio 5.57, 95% CI [2.25–13.80], P = .0002, I 2 = 84%). Albiglutide had glycemic efficacy comparable to other glucose-lowering drugs. CFB in body weight was similar with albiglutide and placebo. AE profile, including gastrointestinal AE, was identical with albiglutide and placebo, except for higher drug-related AE and injection-site reaction with albiglutide. Conclusion: Albiglutide provides reassuring data on good glycemic efficacy, tolerability, and safety over an extended period of clinical use in patients with T2D. Albiglutide 30 mg has comparable efficacy and safety profiles to albiglutide 50 mg.

Abstract licence: CC BY-NC 4.0

Type 2 diabetes mellitus (T2DM) markedly increases the risk of cardiovascular and renal complications, emphasizing the need for therapies that extend benefits beyond glycemic control. Injectable glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have demonstrated both cardioprotective and renoprotective potential, but the comparative efficacy of individual agents remains uncertain. This network meta-analysis (NMA) evaluated and ranked the effects of GLP-1 RAs on major adverse cardiovascular events (MACE) and renal composite outcomes, both prespecified as co-primary endpoints. A systematic search of PubMed, Scopus, ScienceDirect, Web of Science, and the Cochrane Library was conducted from inception to January 2024. Eligible randomized controlled trials enrolled adults with T2DM, including those with or without established cardiovascular disease or chronic kidney disease. Renal composite outcomes were defined as a decline in estimated glomerular filtration rate (eGFR) and/or onset of macroalbuminuria. Direct and indirect evidence were synthesized using a frequentist NMA framework to generate odds ratios (ORs) with 95% confidence intervals (CIs), while treatment hierarchy was assessed with Surface Under the Cumulative Ranking Curve (SUCRA) values. Transitivity and consistency assumptions were tested and satisfied, and the risk of bias was assessed with the Cochrane RoB2 tool. Fifteen randomized trials involving a pooled sample of more than 90,000 participants were included. Efpeglenatide ranked highest for both MACE (OR: 0.74; 95% CI: 0.62-0.87; SUCRA: 81.5%) and renal outcomes (OR: 0.68; 95% CI: 0.57-0.81; SUCRA: 81.33%), underscoring its clinical significance over other effective agents such as albiglutide and semaglutide. Albiglutide, semaglutide, dulaglutide, and liraglutide also provided significant benefits, albeit with lower rankings. No major inconsistency or publication bias was detected. In conclusion, this NMA reinforces the class-wide cardiorenal benefits of GLP-1 receptor agonists while emphasizing variations in efficacy among individual agents, the limited evidence base for certain drugs, and the need for future head-to-head trials specifically designed to evaluate cardiovascular and renal endpoints.

Abstract licence: CC BY

AIMS/HYPOTHESIS: Additional safe and effective therapies for type 2 diabetes are needed, especially ones that do not cause weight gain and have a low risk of hypoglycaemia. The present study evaluated albiglutide as monotherapy. METHODS: In this placebo-controlled study, 309 patients (aged ≥ 18 years) with type 2 diabetes inadequately controlled by diet and exercise and who were not using a glucose-lowering agent (HbA1c 7.0-10.0% [53.00-85.79 mmol/mol], body mass index 20-45 kg/m(2), and fasting C-peptide ≥ 0.26 nmol/l) were randomised (1:1:1 on a fixed randomisation schedule using an interactive voice response system) to receive once-weekly albiglutide 30 mg (n = 102) or 50 mg (n = 102) or matching placebo (n = 105). The study treatments were blinded to both patients and study personnel. All study data were collected at individual patient clinic visits. The primary efficacy endpoint was change in HbA1c from baseline to week 52. The primary analysis was applied to the intent-to-treat population. Additional efficacy and safety endpoints were assessed. RESULTS: At week 52, both albiglutide 30 mg and 50 mg were superior to placebo in reducing HbA1c. The least-squares means treatment difference from placebo was -0.84% (95% CI -1.11%, -0.58%; p < 0.0001) with albiglutide 30 mg and -1.04% (-1.31%, -0.77%; p < 0.0001) with albiglutide 50 mg. Injection-site reactions were reported more frequently with albiglutide (30 mg: 17.8%; 50 mg: 22.2%) than with placebo (9.9%). Other commonly reported adverse events included nausea, diarrhoea, vomiting and hypoglycaemia; the incidences of these were generally similar across treatment groups. CONCLUSIONS/INTERPRETATION: Albiglutide is safe and effective as monotherapy and significantly lowered HbA1c levels over 52 weeks, did not cause weight gain, and had good gastrointestinal tolerability and a low rate of hypoglycaemia compared with placebo. Trial registration ClinicalTrials.gov NCT00849017 Funding This study was sponsored by GlaxoSmithKline.

Abstract licence: CC BY 4.0