Efficacy and safety of bi‐weekly cofrogliptin treatment replacing daily dipeptidyl peptidase‐4 inhibitors in Chinese patients with type 2 diabetes mellitus: A multicenter, open‐label, randomized controlled phase 2 trial
Authors' conclusion
Bi-weekly cofrogliptin treatment, instead of daily DPP-4i, could effectively control blood glucose levels in a 24-week treatment period and their fluctuations and was well tolerated in Chinese patients with T2DM.
Study context
- Population
- Chinese patients with T2D on daily DPP-4irandomized 1:1
- Participants
- 64 patients
- Comparison
- Bi-weekly cofrogliptin 10 mg vs continued daily DPP-4i
- Cofrogliptinn = 31
- Daily DPP-4in = 33reference
- Primary endpoint
- Change in time in range (TIR) (3.9-10.0 mmol/L) from baseline
- Follow-up
- Week 24
Methodological detailsmulticentre, open-label, phase 2, Enrolment 31 January 2024 to 20 November 2024
- Multicentre
- Open-label
- Phase 2
- Enrolment 31 January 2024 to 20 November 2024
Primary result
Change in TIR from baseline · 24 weeks
Least squares (LS) mean difference
9.929 %
95% CI 3.064%–16.793%
P = 0.0046
Change by group
Cofrogliptin
0.037
LS mean · SE 2.506% · %
Daily DPP-4i
−9.891
LS mean · SE 2.435% · %
Between Cofrogliptin and Daily DPP-4i
LS mean difference 9.929 % (95% CI 3.064%–16.793%); P = 0.0046
As reported in the abstract
Safety
Adverse events
- Incidence, classification and severity of AEs similar between groups
Original publication
Efficacy and safety of bi‐weekly cofrogliptin treatment replacing daily dipeptidyl peptidase‐4 inhibitors in Chinese patients with type 2 diabetes mellitus: A multicenter, open‐label, randomized controlled phase 2 trial. Diabetes Obes Metab. Published 20 November 2025. doi:10.
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