OBJECTIVE To assess, in a randomized, double-blind, and placebo-controlled trial, the efficacy and safety of diacerein, an immune modulator anti-inflammatory drug, in improving glycemic control of patients with type 2 diabetes.

RESEARCH DESIGN AND METHODS Eighty-four patients with HbA_1c between 7.5 and 9.5% (58–80 mmol/mol) were randomized to 48-week treatment with placebo (n = 41) or diacerein 100 mg/day (n = 43). The primary outcome was the difference in mean HbA_1c changes during treatment. Secondary outcomes were other efficacy and safety measurements. A general linear regression with repeated measures, adjusted for age, sex, diabetes duration, and each baseline value, was used to estimate differences in mean changes. Both intention-to-treat (ITT) analysis and per-protocol analysis (excluding 10 patients who interrupted treatment) were performed.

RESULTS Diacerein reduced HbA_1c compared with placebo by 0.35% (3.8 mmol/mol; P = 0.038) in the ITT analysis and by 0.41% (4.5 mmol/mol; P = 0.023) in the per-protocol analysis. The peak of effect occurred at the 24th week of treatment (−0.61% [6.7 mmol/mol; P = 0.014] and −0.78% [8.5 mmol/mol; P = 0.005], respectively), but it attenuated toward nonsignificant differences at the 48th week. No significant effect of diacerein was observed in other efficacy and safety measures. Diarrhea occurred in 65% of patients receiving diacerein and caused treatment interruption in 16%. Seven patients in the diacerein group reduced insulin dosage, whereas 10 in the placebo group increased it; however, mild hypoglycemic events were equally observed.

CONCLUSIONS Diacerein reduced mean HbA_1c levels, with peak of effect at the 24th week of treatment. The drug was well tolerated and may be indicated as adjunct treatment in patients with type 2 diabetes, particularly in those with osteoarthritis.

目的在一项随机、双盲和安慰剂对照试验中评估双醋瑞因（一种免疫调节剂抗炎药）在改善 2 型糖尿病患者血糖控制方面的有效性和安全性。

研究设_{_} _ _ _ _ _ 主要结果是治疗期间平均 HbA _1c变化的差异。次要结果是其他疗效和安全性测量。使用重复测量的一般线性回归，调整年龄、性别、糖尿病病程和每个基线值，用于估计平均变化的差异。进行了意向治疗 (ITT) 分析和符合方案分析（不包括 10 名中断治疗的患者）。

结果在 ITT 分析中，与安慰剂相比，双醋瑞因降低了 HbA _{1c 0.35%（3.8 mmol/mol；} P = 0.038），在符合方案分析中降低了 0.41%（4.5 mmol/mol； P = 0.023）。效果峰值出现在治疗的第 24 周（-0.61% [6.7 mmol/mol；P = 0.014] 和 -0.78% [8.5 mmol/mol；P= 0.005]），但它在第 48 周时向不显着的差异减弱。在其他疗效和安全措施中未观察到双醋瑞因的显着影响。65% 接受双醋瑞因的患者出现腹泻，16% 的患者出现治疗中断。双醋瑞因组 7 名患者减少了胰岛素剂量，而安慰剂组 10 名患者增加了胰岛素剂量；然而，同样观察到轻度低血糖事件。

结论双醋瑞因降低了平均 HbA _1c水平，在治疗的第 24 周达到峰值。该药物耐受性良好，可作为 2 型糖尿病患者的辅助治疗，尤其是骨关节炎患者。