Lu C-H, Chang C-C, Chuang L-M, Wang C Y, Jiang Y D, Wu H P
Department of Internal Medicine, Chiayi Christian Hospital, Chiayi, Taiwan.
Diabetes Obes Metab. 2006 Mar;8(2):184-91. doi: 10.1111/j.1463-1326.2005.00501.x.
Gliclazide-modified release (gliclazide MR) is a new formulation of the sulfonylurea gliclazide designed for once-daily administration. The hydrophilic matrix of hypromellose-based polymer in the new formulation induces a progressive drug release, which parallels the 24-h glycaemic profile in type 2 diabetic patients. The aim of this study was to compare the efficacy and safety of gliclazide MR (once-daily administration) versus gliclazide (twice-daily administration) in Chinese type 2 diabetic patients.
Sixty-three type 2 diabetic Chinese patients who had been on diet control alone or on treatment with metformin or on low dose of sulfonylurea were randomized to either gliclazide MR taken once daily or gliclazide taken twice daily. Dosage of metformin was maintained throughout the study, and the sulfonylurea was stopped. The dose of gliclazide MR was increased at 1-month intervals from 30 mg to 120 mg, while that of gliclazide from 80 mg to 320 mg until metabolic control was achieved [fasting plasma glucose (FPG) < or = 7.7 mmol/l] or the maximum dose reached. Efficacy was mainly evaluated by levels of haemoglobin A1c (HbA1c) and FPG.
The mean baseline characteristics of the full analysis set 1 (FAS1) (HbA1c, n = 58) and the FAS2 (FPG, n = 61) were comparable in both groups. The levels of HbA1c decreased similarly in both groups over the treatment period: -1.6 +/- 1.6% (p < 0.001) on gliclazide MR (n = 31) and -1.6 +/- 1.4% (p < 0.001) on gliclazide (n = 27). Decrease in HbA1c was observed irrespective of pre-existing therapy for diabetes: -2.3 +/- 1.5% for patients on diet alone; -0.6 +/- 1.3% for patients switched from sulfonylurea to study drug and -1.4 +/- 0.8% for patients on metformin in combination with study drug. FPG decreased significantly from 177.5 +/- 63.5 to 136.7 +/- 42.2 (p < 0.001, n = 32) on gliclazide MR and not significant from 188.2 +/- 62.6 to 163.7 +/- 67.9 (p = 0.059, n = 29) on gliclazide. Both treatments were very well tolerated with no major hypoglycaemic episodes requiring external assistance; only three patients experienced mild hypoglycaemic episodes.
Once-daily gliclazide MR showed a better trend in improving blood glucose control in comparison with gliclazide in type 2 diabetic Chinese patients irrespective of the pre-existing anti-diabetic treatment. The safety profiles of gliclazide MR and gliclazide were similar with a small number of patients having reported hypoglycaemic episodes. Once-daily dosing with gliclazide MR should improve patient compliance, an important factor in long-term glycaemic control.
格列齐特缓释片（gliclazide MR）是磺脲类药物格列齐特的一种新剂型，设计为每日服用一次。新剂型中基于羟丙甲纤维素的亲水性基质可使药物逐步释放，这与2型糖尿病患者的24小时血糖曲线相平行。本研究的目的是比较格列齐特缓释片（每日一次给药）与格列齐特（每日两次给药）对中国2型糖尿病患者的疗效和安全性。
63例仅接受饮食控制、或正在接受二甲双胍治疗、或正在接受低剂量磺脲类药物治疗的中国2型糖尿病患者，被随机分为每日服用一次格列齐特缓释片组或每日服用两次格列齐特组。在整个研究过程中维持二甲双胍的剂量不变，并停用磺脲类药物。格列齐特缓释片的剂量每隔1个月从30mg增加至120mg，而格列齐特的剂量从80mg增加至320mg，直至达到代谢控制（空腹血糖（FPG）≤7.7mmol/L）或达到最大剂量。疗效主要通过糖化血红蛋白（HbA1c）和FPG水平进行评估。
两组的全分析集1（FAS1）（HbA1c，n = 58）和FAS2（FPG，n = 61）的平均基线特征具有可比性。在治疗期间，两组的HbA1c水平下降情况相似：格列齐特缓释片组（n = 31）下降了-1.6±1.6%（p < 0.001），格列齐特组（n = 27）下降了-1.6±1.4%（p < 0.001）。无论糖尿病的原有治疗方案如何，均观察到HbA1c下降：仅接受饮食治疗的患者下降了-2.3±1.5%；从磺脲类药物转换为研究药物的患者下降了-0.6±1.3%；接受二甲双胍联合研究药物治疗的患者下降了-1.4±0.8%。格列齐特缓释片组的FPG从177.5±63.5显著降至136.7±42.2（p < 0.001, n = 32），而格列齐特组的FPG从188.2±62.6降至163.7±6,7.9，差异无统计学意义（p = 0.059, n = 29）。两种治疗的耐受性均良好，未发生需要外部协助处理的严重低血糖事件；仅有3例患者发生轻度低血糖事件。
在中国2型糖尿病患者中，无论原有抗糖尿病治疗方案如何，每日一次服用格列齐特缓释片在改善血糖控制方面比格列齐特显示出更好的趋势。格列齐特缓释片和格列齐特的安全性相似，仅有少数患者报告发生低血糖事件。每日一次服用格列齐特缓释片应能提高患者的依从性，这是长期血糖控制的一个重要因素。
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