Statistical analysis
hypoglycemic
ADVERSE EVENTS
The primary objective was to determine the superiority of fotagliptin over placebo in the change of HbA1c from baseline to Week 24, and the two-sided test of superiority/non-inferiority design was adopted with α = 0.05 and β = 0.20. According to the phase 3 clinical trial results of other drugs in the same class, it is estimated that the primary efficacy endpoint of HbA1c difference between fotagliptin and placebo is 0.45% [The primary analysis was performed in the full analysis set (FAS), which received at least one dose of the study drug and had at least one posttreatment measurement of the endpoint during the double-blind treatment period. Missing data were imputed using the last observation carried forward (LOCF). HbA1c values at follow-up visits of subjects received rescue were treated as missing values. As a dependent variable, the change of HbA1c from baseline to Week 24 was analyzed using the analysis of covariance (ANCOVA) model. With the treatment group as the fixed effect and the baseline HbA1c as a linear covariate, we assessed the least squares mean and standard error of the primary efficacy endpoint of each treatment group, as well as the differences of the primary efficacy endpoint and its standard error or 95% confidence interval between groups.Descriptive statistics (frequency and percentage) were used to summarize the patient demographics, incidence of adverse events and hypoglycemic episodes by treatment group. Continuous variables, such as physical examination and clinical laboratory evaluations, were summarized by means ± standard deviation (SD) for normally distributed data or medians (interquartile ranges) for non-normally distributed data. All statistical tests were two-sided, with 