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

BackgroundGlucagon-like peptide-1 receptor agonists (GLP-1 RAs) have demonstrated significant cardiovascular (CV) benefits, particularly in patients with diabetes mellitus, but the safety and efficacy of different GLP-1 RAs across diverse populations remain insufficiently defined.ObjectivesPrevious meta-analyses of GLP-1 RAs have been limited by restricted populations, omission of recent trials, or incomplete safety synthesis; this study integrates the latest evidence across 21 randomized controlled trials and diverse populations using advanced meta-analytic methods.MethodsRandomized controlled trials comparing GLP-1 RAs vs controls or placebo were included. Analyses were conducted in prespecified subgroups based on the GLP-1 RA used. Prespecified subgroups according to diabetes mellitus, kidney function, obesity, or heart failure were also performed. Main outcomes comprised mortality (all-cause and CV), trial-defined major adverse cardiovascular events (MACE) and serious adverse events. GRADE (Grading of Recommendations Assessment, Development and Evaluation) and trial sequential analyses were performed to evaluate certainty and conclusiveness of findings, respectively.ResultsA total of 21 trials encompassing 99,599 patients were included. Eight different GLP-1 RAs were used (lixisenatide, liraglutide, exenatide, semaglutide, efpeglenatide, dulaglutide, albiglutide, and tirzepatide), each administered at therapeutic doses and compared vs placebo or controls. Mean follow-up duration was 2.4 years. We found conclusive, high-certainty evidence that GLP-1 RAs reduced all-cause death (incidence rate ratio [IRR]: 0.88; 95% CI: 0.84-0.92; needed to treat [NNT] = 121), CV death (IRR: 0.87; 95% CI: 0.81-0.92; NNT = 170), and MACE (IRR: 0.87; 95% CI: 0.83-0.91; NNT = 66), compared with controls. GLP-1 RAs reduced serious adverse events (-9%), myocardial infarction (-15%), acute kidney failure (-9%), heart failure (-15%), and infections (-10%), but increased gastrointestinal (+63%) and gallbladder (+26%) disorders. There were no differences in stroke, pancreatitis, or neoplasm between groups. Results were mostly consistent across subgroups. Analysis by GLP-1 RA type revealed potential differences in efficacy and safety profiles.ConclusionsGLP-1 RAs reduce mortality and MACE in high-risk populations, highlighting benefits beyond glycemic control. These come at increased gastrointestinal and gallbladder risks. Variation in efficacy and tolerability supports tailoring GLP-1 RA therapy to individual patient characteristics and treatment goals. (PROSPERO [GLP-1 RAs Reduce Mortality and Cardiovascular Events Across the Spectrum of Treated Patients: A Systematic Review and Meta-Analysis]; CRD420251032222).

Abstract licence: CC BY-NC-ND

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

PurposeGlucagon-like peptide-1 receptor agonists (GLP-1 RAs), used to treat type 2 diabetes and obesity, may improve metabolic health before conception. However, their association to hypertensive disorders of pregnancy (HDP) after periconceptional or early pregnancy exposure remains unknown.MethodsWe performed a meta-analysis to investigating association between GLP-1 RAs preconception or first trimester of gestation exposure and HDP risk. Cochrane Central Register of Controlled Trials databases, ClinicalTrials.gov, PubMed, Scopus, and EMBASE databases were searched from inception through December 15, 2025. All eligible studies were observational cohorts. Case reports, reviews, editorials, and studies that lacked HDP data were excluded. We pooled odds ratios with 95% confidence intervals using a random-effects Mantel-Haenszel model. ROBINS-I tool was used to evaluate risk of bias.ResultsOf 75 records identified, 3 retrospective cohort studies met inclusion criteria with 10,880 pregnancies (4942 exposed to GLP-1 RAs and 5938 unexposed). All the studies were conducted in the United States between 2014-2025 and evaluated the semaglutide, liraglutide, dulaglutide, tirzepatide, exenatide, lixisenatide, and albiglutide exposure. Two studies showed a lower HDP risks among exposed pregnant, whereas one study found a higher risk. In the pooled analysis, GLP-1 RA exposure showed a HDP risk with an OR 0.91 (OR 0.91, CI 0.57-1.47) with no statistical significance.ConclusionPericonceptional or first-trimester exposure to GLP-1 RAs are not significantly associated with HDP risk. This available evidence is limited and indicating the need for large prospective studies to establish a possible association between GLP-1 RAs are not significantly associated with HDP risk.

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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.

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AbstractAims/hypothesisAdditional 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.MethodsIn 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/m2, 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.ResultsAt 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/interpretationAlbiglutide 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