Patient characteristics
Comorbidity
A total of 176 patients were enrolled and randomly allocated into sitagliptin (n = 88) and control groups (n = 88). Males numbered 47 (57.3%) and 45 (59.2%) in sitagliptin and control group, respectively (P = 0.87). Of the participants, 18 were excluded from the efficacy analysis because of protocol violation (n = 7), no baseline measurements (n = 5), and no follow-up measurements (n = 6). Two of the seven patients with protocol violation were treated with sitagliptin, despite being assigned to control group. These two patients were therefore only included in the safety analysis. Finally, 158 patients (n = 82 in sitagliptin group and n = 76 in control group) were included in the efficacy analysis, as shown in Fig. Flowchart of subject enrollment. A total of 176 patients were enrolled and randomly allocated into sitagliptin and control groups. Of the 176 participants, 18 were excluded from the efficacy analysis because of protocol violation, no baseline measurements, and no follow-up measurements. Two of the seven patients with protocol violation were treated with sitagliptin, despite being assigned to control group. These two patients who were treated with sitagliptin despite being assigned to control group were included in the safety analysis within sitagliptin group. The number of participants who completed blood tests of each follow-up visit is provided at the blocks of efficacy analysis.Physical and laboratory measurements at baseline.*Between-group differences based on unpaired t-test. Comorbidity and medication at baseline.*Between-group differences based on Fisher’s exact test. 