Efficacy and safety of chiglitazar add‐on to metformin in type 2 diabetes mellitus ( RECAM study)
Authors' conclusion
Chiglitazar combined with metformin significantly improves glycaemic control and lipid metabolism in Chinese patients with T2DM who are inadequately managed with metformin and have a favourable safety profile.
Study context
- Population
- Patients with T2D inadequately controlled by metforminrandomised 1:1:1
- Participants
- 533 patients
- Comparison
- Chiglitazar 32 mg or 48 mg vs placebo, added to metformin
- Chiglitazar 32 mgn = 178
- Chiglitazar 48 mgn = 177
- Placebon = 178reference
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 24
Methodological detailsdouble-blind, phase III
- Double-blind
- Phase III
Primary result
As reported in the abstract
Change in HbA1c
Chiglitazar 32 mg
−0.91
least squares mean · 95% CI −1.03%–-0.79% · %
Chiglitazar 48 mg
−1.14
least squares mean · 95% CI −1.26%–-1.02% · %
Placebo
−0.49
least squares mean · 95% CI −0.62%–-0.36% · %
Chiglitazar 32 mg vs Placebo: P < 0.001 · Chiglitazar 48 mg vs Placebo: P < 0.001 · Chiglitazar 48 mg vs Chiglitazar 32 mg: P = 0.008
Further findings
FPG, 2-h postprandial glucose and lipids
- Chiglitazar significantly improved FPG and 2-h postprandial glucose, reduced TG and free fatty acids and increased HDL-C
Safety
- Incidence of adverse events comparable across groups; slight increase in weight gain and mild oedema with chiglitazar
Original publication
Efficacy and safety of chiglitazar add‐on to metformin in type 2 diabetes mellitus ( RECAM study). Diabetes Obes Metab. Published 22 August 2025. doi:10.
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