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
Authors' conclusion
A 12-week treatment with cofrogliptin provided significant glucose-lowering, and was safe, well tolerated.
Study context
- Population
- Chinese patients with impaired glucose tolerance (IGT)randomized 1:1:1
- Participants
- 99 patients
- Comparison
- Cofrogliptin 10 mg or 25 mg once biweekly vs placebo
- Primary endpoint
- Change from baseline in glucose total AUC0-3 h during meal tolerance test (MTT)
- Follow-up
- Week 12
Methodological detailsphase 2, multicenter, double-blind, placebo-controlled, parallel-group, 261 screened, 99 enrolled
- Phase 2
- Multicenter
- Double-blind
- Placebo-controlled
- Parallel-group
- 261 screened, 99 enrolled
Primary result
As reported in the abstract
Mean change from baseline in glucose total AUC0-3 h during MTT
10 mg
−1.75
mean · mmol h/L
25 mg
−1.54
mean · mmol h/L
Placebo
0.36
mean · mmol h/L
10 mg vs Placebo: P = 0.01 · 25 mg vs Placebo: P = 0.02
Secondary outcomes
Change from baseline in Cmax of glucose during meal tolerance test (MTT) 0-3 h · week 12
- Significant benefit with cofrogliptin vs placebo
Change from baseline in glucose total AUC0-3 h and Cmax of glucose during OGTT 0-3 h · week 10
- Significant benefit with cofrogliptin vs placebo
Normoglycaemia · week 10
- More cofrogliptin-treated patients achieved normoglycaemia vs placebo
Safety
Adverse events
- Serious AEs or severe hypoglycaemia
- 0
- Incidence of AEs generally comparable in all groups; all AEs mild or moderate
Original publication
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. Diabetes Obes Metab. Published 4 December 2024. doi:10.
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