Chiglitazar(Carfloglitazar)is a novel non-thiazolidinedione(TZD)structured peroxisome proliferatoractivated receptor(PPAR)pan-agonist that has shown promising effects on glycemic control and lipid regulation in patien...Chiglitazar(Carfloglitazar)is a novel non-thiazolidinedione(TZD)structured peroxisome proliferatoractivated receptor(PPAR)pan-agonist that has shown promising effects on glycemic control and lipid regulation in patients with type 2 diabetes in previous clinical studies.This randomized phase 3 trial aimed to compare the efficacy and safety of chiglitazar with placebo in patients with type 2 diabetes with insufficient glycemic control by strict diet and exercise alone.Eligible patients were randomly assigned to receive chiglitazar 32 mg(n=167),chiglitazar 48 mg(n=166),or placebo(n=202)once daily.The primary endpoint was the change in glycosylated hemoglobin A_(1c)(HbA_(1c))at week 24 with superiority of chiglitazar over placebo.The results showed that both chiglitazar 32 and 48 mg resulted in significant and clinically meaningful reductions in HbA_(1c),and placebo-adjusted estimated treatment differences at week 24 for chiglitazar 32 and 48 mg were-0.87%(95%confidential interval(CI):-1.10 to-0.65;P<0.0001)and-1.05%(95%CI:-1.29 to-0.81;P<0.0001),respectively.Secondary efficacy parameters including glycemic control,insulin sensitivity and triglyceride reduction were also significantly improved in the chiglitazar groups.The overall frequency of adverse events and study discontinuation attributable to adverse events were similar among the groups.Low incidences of mild edema and body weight gain were reported in the chiglitazar dose groups.The results from this phase 3 trial demonstrated that the PPAR pan-agonist chiglitazar possesses an overall good efficacy and safety profile in patients with type 2 diabetes inadequately controlled with lifestyle interventions,thereby providing adequate supporting evidence for using this PPAR pan-agonist as a treatment option for type 2 diabetes.展开更多
目的研究高抗性淀粉(resistant starch,RS)宜糖米对2型糖尿病患者血糖的影响。方法 60例2型糖尿病患者,随机分为抗性淀粉组和拜唐苹组,在口服降糖药物和胰岛素治疗不变的情况下,第1天普通饮食,第2、3天给予高抗性淀粉宜糖米饮食和拜唐苹...目的研究高抗性淀粉(resistant starch,RS)宜糖米对2型糖尿病患者血糖的影响。方法 60例2型糖尿病患者,随机分为抗性淀粉组和拜唐苹组,在口服降糖药物和胰岛素治疗不变的情况下,第1天普通饮食,第2、3天给予高抗性淀粉宜糖米饮食和拜唐苹,试验前患者佩戴动态血糖监测仪,比较3天平均血糖,早、中、晚餐后平均血糖,血糖波动系数,高血糖、低血糖时间比的差异。结果两组患者第2、3天血糖平均水平明显降低(P<0.01),单日平均血糖、空腹、早餐后、中餐后、晚餐后平均血糖均明显降低(P<0.05),最高血糖水平降低(P<0.01),最低血糖水平较前无明显变化,最高低血糖差减小(P<0.01),单日>7.8 m m ol/l及>11.1 m m ol/l高血糖时间比较饮食治疗前明显降低(P<0.01,P<0.05),血糖波动系数降低(P<0.01)。结论高抗性淀粉宜糖米和拜唐苹均能显著降低2型糖尿病患者血糖平均水平,显著降低餐后血糖,减少血糖波动。展开更多
基金grants from Chinese National and Provincial Major Project for New Drug Innovation(National:2008ZX09101-002 and 2013ZX09401301Provincial:2011A080501010)Shenzhen Municipal Major Project(2010-1746)。
文摘Chiglitazar(Carfloglitazar)is a novel non-thiazolidinedione(TZD)structured peroxisome proliferatoractivated receptor(PPAR)pan-agonist that has shown promising effects on glycemic control and lipid regulation in patients with type 2 diabetes in previous clinical studies.This randomized phase 3 trial aimed to compare the efficacy and safety of chiglitazar with placebo in patients with type 2 diabetes with insufficient glycemic control by strict diet and exercise alone.Eligible patients were randomly assigned to receive chiglitazar 32 mg(n=167),chiglitazar 48 mg(n=166),or placebo(n=202)once daily.The primary endpoint was the change in glycosylated hemoglobin A_(1c)(HbA_(1c))at week 24 with superiority of chiglitazar over placebo.The results showed that both chiglitazar 32 and 48 mg resulted in significant and clinically meaningful reductions in HbA_(1c),and placebo-adjusted estimated treatment differences at week 24 for chiglitazar 32 and 48 mg were-0.87%(95%confidential interval(CI):-1.10 to-0.65;P<0.0001)and-1.05%(95%CI:-1.29 to-0.81;P<0.0001),respectively.Secondary efficacy parameters including glycemic control,insulin sensitivity and triglyceride reduction were also significantly improved in the chiglitazar groups.The overall frequency of adverse events and study discontinuation attributable to adverse events were similar among the groups.Low incidences of mild edema and body weight gain were reported in the chiglitazar dose groups.The results from this phase 3 trial demonstrated that the PPAR pan-agonist chiglitazar possesses an overall good efficacy and safety profile in patients with type 2 diabetes inadequately controlled with lifestyle interventions,thereby providing adequate supporting evidence for using this PPAR pan-agonist as a treatment option for type 2 diabetes.
文摘目的研究高抗性淀粉(resistant starch,RS)宜糖米对2型糖尿病患者血糖的影响。方法 60例2型糖尿病患者,随机分为抗性淀粉组和拜唐苹组,在口服降糖药物和胰岛素治疗不变的情况下,第1天普通饮食,第2、3天给予高抗性淀粉宜糖米饮食和拜唐苹,试验前患者佩戴动态血糖监测仪,比较3天平均血糖,早、中、晚餐后平均血糖,血糖波动系数,高血糖、低血糖时间比的差异。结果两组患者第2、3天血糖平均水平明显降低(P<0.01),单日平均血糖、空腹、早餐后、中餐后、晚餐后平均血糖均明显降低(P<0.05),最高血糖水平降低(P<0.01),最低血糖水平较前无明显变化,最高低血糖差减小(P<0.01),单日>7.8 m m ol/l及>11.1 m m ol/l高血糖时间比较饮食治疗前明显降低(P<0.01,P<0.05),血糖波动系数降低(P<0.01)。结论高抗性淀粉宜糖米和拜唐苹均能显著降低2型糖尿病患者血糖平均水平,显著降低餐后血糖,减少血糖波动。
