Study design and randomization
T2DM
TYPE 2 DIABETES MELLITUS
Patients with type 2 diabetes mellitus (T2DM) were randomized to receive fotagliptin, alogliptin or placebo. Subjects who met the inclusion criteria would enter the 4 weeks of placebo run-in period. At the end of the run-in period, a baseline enrollment evaluation was performed. Upon evaluation, all eligible subjects would enter the 24 weeks of double-blind treatment period and were randomized into the fotagliptin group (12 mg once daily) or alogliptin group (25 mg once daily) or placebo group at a 2:1:1 ratio. Randomization and drug dispensation were performed with an interactive web response system (IWRS;eBalance version 5.3.7). A stratified randomization method with the permuted block randomization algorithm was used. The blocks were dynamically allocated to each site and stratum from the randomization list. A unique ID number was provided by the vendor and marked on the medication box. Using central randomization, randomization codes were assigned to eligible participants by the IWRS system based on stratification factors (baseline HbA1c level < 8.5% or ≥ 8.5%) and the block size. After 24 weeks of double-blind treatment, subjects would enter the extended open-label treatment period. Subjects in the placebo group were to be switched to fotagliptin (12 mg once daily) treatment, while patients in the fotagliptin and alogliptin groups continued the same treatment until the end of the whole 52 weeks.The trial was conducted in accordance with the 