Safety, tolerability, pharmacokinetics and pharmacodynamics of albiglutide, a long-acting GLP-1-receptor agonist, in Japanese subjects with type 2 diabetes mellitus

AbstractObjective:To investigate safety, pharmacokinetics and pharmacodynamics of albiglutide in Japanese subjects with type 2 diabetes mellitus.Research design and methods:This randomized, single-blind, placebo-controlled study examined four doses/dose schedules of subcutaneously (sc) administered albiglutide: 15 mg weekly, 30 mg weekly, 50 mg biweekly, and 100 mg monthly (cohorts A–D, respectively) in 40 subjects (mean age 54.5 years, mean range of glycosylated hemoglobin [HbA1c] 7.1–8.3%), over a 4-week treatment period.Main outcome measures:Safety parameters, including adverse events, clinical laboratory tests, vital signs, and 12-lead electrocardiogram; plasma concentrations of albiglutide; and pharmacodynamic parameters, including change from baseline and weighted mean AUC0–4 in plasma glucose, glucagon, insulin, and C-peptide levels.Clinical trial registration:NCT00530309.Results:At day 29, mean changes from baseline (vs. placebo) in fasting plasma glucose (FPG) were: cohort A, −1.92 mmol/L; B, −1....