Results
T2DM, SD
REGRESSION, EVENTS, SECONDARY, ADVERSE EVENTS
In all, a total of 836 patients with T2DM from 56 sites were screened for eligibility. After the run-in period, 458 patients were randomized in the double-blind period as follows: 230 patients in the fotagliptin group, 113 patients in the alogliptin group, and 115 patients in the placebo group. In the fotagliptin group, alogliptin group and placebo group, 19 (8.2%), 14 (12.3%), and 9 (7.8%) patients prematurely discontinued the study and the most common reason for study discontinuation was voluntary withdrawal (9, 10, and 9 patients, respectively). There were 91% (416/458) patients compliant with the study drug dosing throughout the double-blind period while 94% (389/416) of these patients completed the whole 52-week treatment period. Details of the patients’ disposition are showed in Fig. Study patient dispositionDemographic and clinical characteristics of the patients at baseline1 Data were means ± SD or medians (interquartile ranges) for skewed variables or numbers (proportions) for categorical variables2 P for trend was calculated for the linear regression analysis tests across the groups. 3 The primary efficacy endpoint was change from baseline in HbA1c at Week 24. As shown in Fig. Differences in primary clinical end points (Full-analysis-set). Compared with subjects with placebo, significantly more patients with fotagliptin and alogliptin achieved the HbA1c targets (< 7.0% and ≤ 6.5%) after 24 weeks of treatment: 20.7%, 20.0% and 4.4% patients achieved HbA1c ≤ 6.5% in the fotagliptin group, alogliptin group and placebo group, respectively; 37.0%, 35.5% and 15.5% patients achieved HbA1c < 7.0% in the fotagliptin group, alogliptin group and placebo group, respectively (Fig. Differences in secondary endpoints. (Full-analysis-set). In contrast to placebo, fotagliptin and alogliptin resulted in significantly greater decrease in mean FBG after 24 weeks of treatment (Fig. Changes in additional efficacy measures from baseline to Week 24 and Week 52 are provided in Table Change in additional secondary measures of efficacy from baseline to week 24 and week 52Table Summary of clinical adverse events in the treated set of safety population1 The safety population was defined as patients who took at least one dose of therapeutic drug or placebo2 Data are number (% of total participants in treatment group)3 *4 This table lists serious adverse events that were present in more than 2% of the patients in either trial group, adverse events that were considered to be related to therapeutic drug or placebo in more than 5% of the patients in either trial group, and any other safety events of special interest