Efficacy and safety of an albiglutide liquid formulation compared with the lyophilized formulation: A 26-week randomized, double-blind, repeat-dose study in patients with type 2 diabetes mellitus.
AIMS
Compare the efficacy and safety of albiglutide from a ready-to-use, single-dose, auto-injector system with the lyophilized product in patients with type 2 diabetes mellitus (T2DM).


METHODS
In this phase 3 study, 308 patients between 18 and 80 years with T2DM and experiencing inadequate glycemic control on their current regimen of diet/exercise alone or in combination with metformin were randomized 1:1 to weekly injections for 26 weeks with an active albiglutide auto-injector and placebo lyophilized dual-chamber cartridge (DCC) pen injector (n = 154) or active albiglutide lyophilized DCC pen injector and placebo liquid auto-injector (n = 154). Participants received liquid or lyophilized albiglutide 30 mg for 4 weeks, and then 50 mg for the remaining 22 weeks. Change in HbA1c and fasting plasma glucose (FPG), pharmacokinetics, and safety were assessed.


RESULTS
In the albiglutide liquid and lyophilized drug product groups, 55.6% (85/153) and 45.5% of patients (70/154) had a baseline HbA1c ≥ 8.0%, respectively. The model-adjusted least squares (LS) mean change in HbA1c from baseline at week 26 was -1.1% (95% CI: -1.3, -1.0) and -1.2% (95% CI: -1.3, -1.0; noninferiority P = 0.0002) in the albiglutide liquid and lyophilized product groups, respectively. Similarly, the model-adjusted LS mean change in FPG from baseline at week 26 in the albiglutide liquid and lyophilized product groups was -2.2 (95% CI: -2.6, -1.8) mmol/L and -1.9 (95% CI: -2.3, -1.5) mmol/L, respectively. No new safety concerns were identified.


CONCLUSION
Change from baseline in HbA1c for albiglutide liquid was noninferior to lyophilized drug product in patients with T2DM.
['Shaddinger|Bonnie C|BC|', 'Soffer|Joseph|J|', 'Vlasakakis|Georgios|G|', 'Shabbout|Mayadah|M|', 'Weston|Cindy|C|', 'Nino|Antonio|A|']
D000293:Adolescent D000328:Adult D000368:Aged D000369:Aged, 80 and over D001786:Blood Glucose D003924:Diabetes Mellitus, Type 2 D004305:Dose-Response Relationship, Drug D004311:Double-Blind Method D004334:Drug Administration Schedule D004339:Drug Compounding D005260:Female D005612:Freeze Drying D052216:Glucagon-Like Peptide 1 D006442:Glycated Hemoglobin A D006801:Humans D007004:Hypoglycemic Agents D008297:Male D008687:Metformin D008875:Middle Aged D012996:Solutions D016896:Treatment Outcome D055815:Young Adult
Albiglutide Liquid formulation Type 2 diabetes mellitus GLP-1 receptor agonist