Key result
Chiglitazar 32 mg and 48 mg were superior to placebo in reducing HbA1c at 24 weeks (LS mean difference -0.87% and -1.05%, respectively).
Why the study?
Following favorable phase 2 results, this trial aimed to compare the efficacy and safety of chiglitazar with placebo in patients with type 2 diabetes inadequately controlled with lifestyle interventions.
Does chiglitazar reduce HbA1c in patients with type 2 diabetes inadequately controlled with lifestyle interventions?
RCT (n=535)
Double-blind
Randomized
Does chiglitazar reduce HbA1c in patients with type 2 diabetes inadequately controlled with lifestyle interventions?
Mean Difference: -0.87 (95% CI -1.1–-0.65)
Chiglitazar, a novel PPAR pan-agonist, significantly improves glycemic control at 24 weeks compared to placebo in patients with type 2 diabetes inadequately controlled by lifestyle interventions.
Chiglitazar may expand oral options for type 2 diabetes; confirms efficacy versus placebo in an RCT.
Chiglitazar showed favorable effect on glycemic control and lipid modulation with well tolerated safety profile in phase 2 trials. This trial aimed to further compare the efficacy and safety of chiglitazar with placebo in patients with type 2 diabetes inadequately controlled with lifestyle interventions (ClinicalTrials.gov NCT02121717). Patients were randomly assigned to receive chiglitazar 32 mg or 48 mg, or placebo once daily. After 24-week treatment, patients in placebo group were randomly assigned to receive chiglitazar 32 mg or 48 mg, while others remained on the planned treatment till to 52 weeks. The primary endpoint was change in HbA1c at week 24 with superiority of each chiglitazar dose versus placebo. Analysis was done in all randomized patients who received at least one dose of study drug (n= 535). Chiglitazar was superior to placebo in HbA1c reduction at 24 weeks (LS mean difference -0.87% [95% CI -1.10 to -0.65] and -1.05% [95% CI -1.29 to -0.81] for 32 mg and 48 mg, respectively) and achieved sustainable effect till to 52 weeks. Overall adverse events were comparable across groups. The incidences of weight gain, edema, and hypoglycemia were relatively higher in chiglitazar groups. Chiglitazar showed superior and sustainable HbA1c lowering effect with well tolerated safety profile in patients with type 2 diabetes. Disclosure L. Ji: Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck KGaA, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi, Takeda Pharmaceutical Company Limited. Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Roche Pharma, Sanofi. W. Song: None. H. Fang: None. W. Li: None. J. Geng: None. Y. Xu: None. Y. Wang: None. L. Guo: None. H. Cai: None. T. Yang: None. H. Li: None. G. Yang: None. Q. Li: None. K. Liu: None. S. Li: None. Y. Liu: None. F. Shi: None. X. Li: None. X. Gao: None. Q. Ji: None. H. Tian: None. Q. Su: None. Z. Zhou: None. W. Wang: None. Z. Zhou: None. X. Li: None. Y. Xu: None. Z. Ning: None. X. Lu: None. W. Jia: None. Funding Ministry of Science and Technology of the People´s Republic of China (2013ZX09401301)
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Ji et al. (2019) conducted an RCT in Type 2 diabetes (n=535). Chiglitazar vs. Placebo was evaluated on Change in HbA1c at week 24 (MD -0.87% (32 mg) and -1.05% (48 mg), 95% CI -1.10 to -0.65 (32 mg) and -1.29 to -0.81 (48 mg)). Chiglitazar 32 mg and 48 mg were superior to placebo in reducing HbA1c at 24 weeks (LS mean difference -0.87% and -1.05%, respectively).
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