Cofrogliptin once every 2 weeks as add‐on therapy to metformin versus daily linagliptin in patients with type 2 diabetes in China: A randomized, double‐blind, non‐inferiority trial
Authors' conclusion
In Chinese patients with type 2 diabetes inadequately controlled on metformin, the glucose-lowering effect of cofrogliptin (Q2W) was non-inferior to linagliptin (daily), with a similar safety profile maintained over 52 weeks of treatment.
Study context
- Population
- Patients with T2D inadequately controlled on metformin in China; median age 57.0 yearsrandomized 1:1:1
- Participants
- 465 patients
- Comparison
- Cofrogliptin Q2W vs daily linagliptin, add-on to metformin
- Primary endpoint
- Change in HbA1c from baseline, non-inferiority margin 0.4% for cofrogliptin vs linagliptin
- Follow-up
- 24 weeks
Methodological detailsphase 3, double-blind, active-controlled, multicentre, non-inferiority, open-label extension, Open-label extension: eligible patients received cofrogliptin 25 mg Q2W for an additional 28 weeks
- Phase 3
- Double-blind
- Active-controlled
- Multicentre
- Non-inferiority
- Open-label extension
- Open-label extension: eligible patients received cofrogliptin 25 mg Q2W for an additional 28 weeks
Primary result
As reported in the abstract
Change in HbA1c from baseline · week 24
Cofrogliptin 10 mg
−0.96
least-squares mean · SE 0.063
Cofrogliptin 25 mg
−0.99
least-squares mean · SE 0.064
Linagliptin 5 mg
−1.07
least-squares mean · SE 0.065
Safety
Common adverse events (≥5% patients) · 24-week treatment period
- Incidence similar between treatment groups
Serious hypoglycaemic events
- No serious hypoglycaemic events
Original publication
Cofrogliptin once every 2 weeks as add‐on therapy to metformin versus daily linagliptin in patients with type 2 diabetes in China: A randomized, double‐blind, non‐inferiority trial. Diabetes Obes Metab. Published 23 September 2024. doi:10.
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