PDF(Pubmed)
Abstract：
BACKGROUND: Due to the progressive decline in β-cell function, it is often necessary to utilize multiple agents with complementary mechanisms of action to address various facets and achieve glycemic control. Thus, this study aimed to evaluate the efficacy and safety of a fixed-dose combination (FDC) of metformin/sitagliptin/pioglitazone (MSP) therapy vs. metformin/sitagliptin (MS) in type 2 diabetes mellitus (T2DM).
METHODS: In this phase 3, multicenter, double-blind study, patients with T2DM who exhibited inadequate glycemic control with HbA1c of 8.0-11.0% while taking ≥1500 mg/day metformin for at least 6 weeks were randomized to receive either FDC of MSP (1000/100/15 mg) or MS (1000/100 mg) per day for 24 weeks. The primary outcome measure was the change in HbA1c, and secondary outcomes included changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and body weight from baseline to 24 weeks along with safety and tolerability.
RESULTS: Among the 236 patients randomized, 207 (87.71%) successfully completed the study. All baseline characteristics were comparable between the FDC of MSP and MS groups. There was a subsequent significant reduction of HbA1c in FDC of MSP (- 1.64) vs. MS (- 1.32); between groups was [- 0.32% (95% CI, - 0.59, - 0.05)], P = 0.0208. Similar reductions were found in FPG [- 13.2 mg/dL (95% CI, - 22.86, - 3.71)], P = 0.0068, and PPG [- 20.83 mg/dL (95% CI, - 34.11, - 7.55)], P = 0.0023. There were no significant changes in body weight. A total of 27 adverse effects (AEs) and one severe AE were reported, none of which were related to the study drug.
CONCLUSIONS: The FDC of MSP demonstrated significant efficacy in managing glycemic indices and could serve as a valuable tool for physicians in the management of Indian patients with T2DM.
BACKGROUND: Clinical Trials Registry of India, CTRI/2021/10/037461.
METHODS: In this phase 3, multicenter, double-blind study, patients with T2DM who exhibited inadequate glycemic control with HbA1c of 8.0-11.0% while taking ≥1500 mg/day metformin for at least 6 weeks were randomized to receive either FDC of MSP (1000/100/15 mg) or MS (1000/100 mg) per day for 24 weeks. The primary outcome measure was the change in HbA1c, and secondary outcomes included changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and body weight from baseline to 24 weeks along with safety and tolerability.
RESULTS: Among the 236 patients randomized, 207 (87.71%) successfully completed the study. All baseline characteristics were comparable between the FDC of MSP and MS groups. There was a subsequent significant reduction of HbA1c in FDC of MSP (- 1.64) vs. MS (- 1.32); between groups was [- 0.32% (95% CI, - 0.59, - 0.05)], P = 0.0208. Similar reductions were found in FPG [- 13.2 mg/dL (95% CI, - 22.86, - 3.71)], P = 0.0068, and PPG [- 20.83 mg/dL (95% CI, - 34.11, - 7.55)], P = 0.0023. There were no significant changes in body weight. A total of 27 adverse effects (AEs) and one severe AE were reported, none of which were related to the study drug.
CONCLUSIONS: The FDC of MSP demonstrated significant efficacy in managing glycemic indices and could serve as a valuable tool for physicians in the management of Indian patients with T2DM.
BACKGROUND: Clinical Trials Registry of India, CTRI/2021/10/037461.
摘要：
背景：由于β细胞功能的进行性下降，通常需要使用具有互补作用机制的多种药物来解决各个方面并实现血糖控制.因此，这项研究旨在评估二甲双胍/西格列汀/吡格列酮（MSP）治疗的固定剂量组合（FDC）的疗效和安全性。二甲双胍/西格列汀（MS）在2型糖尿病（T2DM）中的应用。
方法：在此阶段3，多中心，双盲研究,在服用二甲双胍≥1500mg/d至少6周的情况下,HbA1c为8.0~11.0%的血糖控制不佳的T2DM患者被随机分组接受FDC,每天MSP(1000/100/15mg)或MS(1000/100mg),共24周.主要结果指标是HbA1c的变化，次要结局包括空腹血糖（FPG）的变化，餐后血浆葡萄糖（PPG），从基线到24周的体重以及安全性和耐受性。
结果：在随机分组的236例患者中，207人(87.71%)成功完成研究。所有基线特征在MSP和MS组的FDC之间具有可比性。随后，MSP的FDC中HbA1c显着降低（-1.64）与MS（-1.32）；组间为[-0.32%（95%CI，-0.59，-0.05）]，P=0.0208。在FPG中发现了类似的减少[-13.2mg/dL（95％CI，-22.86，-3.71）]，P=0.0068，PPG[-20.83mg/dL（95%CI，-34.11，-7.55）]，P=0.0023。体重没有显著变化。共报告了27种不良反应（AE）和1种严重的AE。这些都与研究药物无关。
结论：MSP的FDC在控制血糖指数方面显示出显著的疗效，并且可以作为医生管理印度T2DM患者的有价值的工具。
背景：印度临床试验注册中心，CTRI/2021/10/037461。
方法：在此阶段3，多中心，双盲研究,在服用二甲双胍≥1500mg/d至少6周的情况下,HbA1c为8.0~11.0%的血糖控制不佳的T2DM患者被随机分组接受FDC,每天MSP(1000/100/15mg)或MS(1000/100mg),共24周.主要结果指标是HbA1c的变化，次要结局包括空腹血糖（FPG）的变化，餐后血浆葡萄糖（PPG），从基线到24周的体重以及安全性和耐受性。
结果：在随机分组的236例患者中，207人(87.71%)成功完成研究。所有基线特征在MSP和MS组的FDC之间具有可比性。随后，MSP的FDC中HbA1c显着降低（-1.64）与MS（-1.32）；组间为[-0.32%（95%CI，-0.59，-0.05）]，P=0.0208。在FPG中发现了类似的减少[-13.2mg/dL（95％CI，-22.86，-3.71）]，P=0.0068，PPG[-20.83mg/dL（95%CI，-34.11，-7.55）]，P=0.0023。体重没有显著变化。共报告了27种不良反应（AE）和1种严重的AE。这些都与研究药物无关。
结论：MSP的FDC在控制血糖指数方面显示出显著的疗效，并且可以作为医生管理印度T2DM患者的有价值的工具。
背景：印度临床试验注册中心，CTRI/2021/10/037461。
