Fasiglifam for glycaemic control in people with type 2 diabetes: A phase III, placebo-controlled study.

Aim: To investigate the effect of fasiglifam on glycaemic control in people with type 2 diabetes mellitus (T2DM).

Methods: In total, 421 people with T2DM and glycated haemoglobin (HbA1c) ≥7.0% and ≤10.5% who had received only diet and exercise treatment for ≥12 weeks prior to screening were randomized to receive fasiglifam 25 or 50 mg or placebo. The primary efficacy endpoint was change from baseline in HbA1c at week 24.

Results: The mean participant age was 53.5 years, mean baseline body mass index 32.3 kg/m , and mean baseline HbA1c level 8.05%. Least squares mean changes in HbA1c from baseline to week 24 were: -0.93% (fasiglifam 50 mg), -0.65% (fasiglifam 25 mg) and -0.17% (placebo). Treatment-emergent adverse events (TEAEs) occurred in 53.3%, 48.2% and 39.9% of participants receiving fasiglifam 25 mg, fasiglifam 50 mg, and placebo, respectively. Three participants in each group experienced a serious adverse event (AE). Nine participants had alanine aminotransferase (ALT) elevations >3× upper limit of normal: 5 (3.6%) in the fasiglifam 25-mg group, 4 (2.8%) in the fasiglifam 50-mg group, and none in the placebo group.

Conclusions: The data indicate that fasiglifam effectively reduced HbA1c from baseline for 24 weeks in participants with T2DM. The incidence of TEAEs was higher in the fasiglifam groups; however, the incidence of serious AEs was low overall and similar between groups. ALT elevations were observed only in the fasiglifam groups, which contributed to the decision to terminate the fasiglifam programme after completion of the present study.