Nino A, et al. - The clinicians aimed to evaluate the efficacy and safety of albiglutide compared with placebo in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled by diet and exercise with or without a single oral antidiabetic drug in this phase 3, randomized, double-blind 24-week study with extension to 1 year. In these patients, albiglutide monotherapy achieved clinically significant decreases in HbA1c and fasting plasma glucose with good tolerability.

• For this study, patients received weekly albiglutide 30 mg (n=160), albiglutide 50 mg (n=150), or placebo switched to albiglutide 30 mg after 24 weeks (n=77).
• The clinicians included open-label daily liraglutide 0.9 mg (n=103) as a reference.
• Before baseline, oral antidiabetic drug use was discontinued.
• 24-week change from baseline in HbA1c was the primary endpoint.
• Fasting plasma glucose, body weight, and adverse events (AEs) were included as secondary endpoints.

• For albiglutide 30 mg, 50 mg, and placebo, mean HbA1c changes from baseline were -1.10%, -1.30%, and 0.25%, respectively (p vs. placebo <0.0001 for both albiglutide doses), -1.19% for liraglutide at 24 weeks.
• With albiglutide, decreases in HbA1c were sustained through the study.
• Across groups, mean fasting plasma glucose decreased by ≥20 mg/dL and mean change in body weight was ≤0.5 kg through 1 year.
• Nasopharyngitis, constipation, and nausea were the most commonly reported AEs.
• In active treatment groups, incidence of AEs was higher than placebo.
• The clinicians observed few hypoglycemia events.
• No patient withdrew because of hypoglycemia.
• There were no new safety signals.