Efficacy and safety of chiglitazar add‐on to metformin in type 2 diabetes mellitus ( RECAM study)
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Le résumé fourni par la source
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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04807348).
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé, mais le titre doit être comparé manuellement.
- Titre Crossref
- Efficacy and safety of chiglitazar add‐on to metformin in type 2 diabetes mellitus ( <scp>RECAM</scp> study)
- Date Crossref
- 22/08/2025
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Peking University Department of Endocrinology and Metabolism pays non établi dans la noticeUniversité ou école supérieure
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Peking University People's Hospital pays non établi dans la noticeÉtablissement de santé
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Jinan Central Hospital Department of Endocrinology pays non établi dans la noticeÉtablissement de santé
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Harbin Medical University Department of Endocrinology and Metabolism pays non établi dans la noticeUniversité ou école supérieure
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Fourth Affiliated Hospital of Harbin Medical University pays non établi dans la noticeÉtablissement de santé
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Yueyang Second People's Hospital pays non établi dans la noticeÉtablissement de santé
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Nanjing First Hospital Department of Endocrinology pays non établi dans la noticeÉtablissement de santé
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Chenzhou First People's Hospital Department of Endocrinology pays non établi dans la noticeÉtablissement de santé
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Second Affiliated Hospital of Nanjing Medical University pays non établi dans la noticeÉtablissement de santé
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Nanjing Medical University Department of Endocrinology pays non établi dans la noticeUniversité ou école supérieure
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Zhuzhou Central Hospital Department of Endocrinology pays non établi dans la noticeÉtablissement de santé
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Henan University Huaihe Hospital and Huaihe Clinical Institute pays non établi dans la noticeÉtablissement de santé
Department of Endocrinology and Metabolism — Peking University, Peking University People's Hospital et Department of Endocrinology — Jinan Central Hospital, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.