A biweekly DPP-4 inhibitor cofrogliptin monotherapy in Chinese patients with impaired glucose tolerance: A phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial.

Aims: To assess the efficacy and safety of cofrogliptin for impaired glucose tolerance (IGT).

Methods: In this multicenter, double-blind, placebo-controlled phase 2 trial, IGT patients were randomized 1:1:1 to receive cofrogliptin 10 mg, cofrogliptin 25 mg or placebo once biweekly. The primary endpoint was the change from baseline in glucose total AUC_{0-3 h} during meal tolerance test (MTT) at week 12.

Results: Among 261 subjects screened, 99 were enrolled. At week 12, significant mean reductions from baseline in glucose total AUC_{0-3 h} during MTT were observed in cofrogliptin groups (10 mg: -1.75 mmol h/L, p = 0.01; 25 mg: -1.54 mmol h/L, p = 0.02) versus placebo (0.36 mmol h/L). Significant benefits were also seen with cofrogliptin for secondary endpoints of the change from baseline in C_max of glucose during MTT 0-3 h at week 12, and the change from baseline in glucose total AUC_{0-3 h} and C_max of glucose during OGTT 0-3 h at week 10 versus placebo. Additionally, more cofrogliptin-treated patients achieved normoglycaemia versus placebo at week 10. The incidence of AEs was generally comparable in all groups, and all of AEs were mild or moderate. No serious AEs or severe hypoglycaemia were reported.

Conclusion: A 12-week treatment with cofrogliptin provided significant glucose-lowering, and was safe, well tolerated.