Efficacy and safety of chiglitazar add-on to metformin in type 2 diabetes mellitus (RECAM study)
Abstract
Aims: Chiglitazar is a novel peroxisome proliferator-activated receptor pan-agonist regulating glucose and lipid metabolism. The RECAM study aimed to evaluate the efficacy and safety of chiglitazar add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM).
Materials and methods: In this randomised, double-blind, phase III trial (NCT04807348), 533 patients with T2DM inadequately controlled by metformin were randomly assigned in a 1:1:1 ratio to receive chiglitazar 32 mg (n = 178), chiglitazar 48 mg (n = 177), or placebo (n = 178) for 24 weeks, in addition to metformin. The primary endpoint was the change in glycosylated haemoglobin (HbA1c) from baseline to week 24.
Results: At week 24, the least squares mean changes in HbA1c were -0.91% (95% CI: -1.03% to -0.79%) in the chiglitazar 32 mg group, -1.14% (95% CI: -1.26% to -1.02%) in the chiglitazar 48 mg group, and -0.49% (95% CI: -0.62% to -0.36%) in the placebo group. Both chiglitazar 32 mg and 48 mg significantly reduced HbA1c compared to placebo (both p < 0.001), with the reduction being greater in the 48 mg group than in the 32 mg group (p = 0.008). Chiglitazar significantly improved fasting plasma glucose and 2-h postprandial glucose while reducing triglyceride and free fatty acid levels and increasing high-density lipoprotein cholesterol levels. The incidence of adverse events was comparable across groups, with a slight increase in weight gain and mild oedema observed in the chiglitazar groups.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 533 participants or records.
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