Department of Endocrinology, Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, China.
Clin Drug Investig. 2013 Mar;33(3):185-91. doi: 10.1007/s40261-013-0054-4.
Diabetes mellitus has become a major public health problem in China. This open-label, prospective, multicentre, post-marketing surveillance study was conducted to investigate the efficacy and safety of nateglinide in combination with metformin in Chinese patients with type 2 diabetes (T2DM).
A total of 892 patients with T2DM were included in the study, of whom 361 subjects had been pretreated with metformin and 531 subjects had not previously been treated with any oral antihyperglycaemic agent. All enrolled patients received 120 mg of nateglinide three times daily within 15 minutes before meals together with metformin (with no restrictions on dosage or frequency of administration) for 12 weeks. Physical examination, laboratory tests and relevant tests in terms of efficacy were performed, and adverse events and subject compliance were documented and monitored.
From baseline to week 12, glycosylated haemoglobin (HbA1c) was reduced by 1.52 % ± 1.25 % (mean ± SD), fasting plasma glucose (FPG) by 1.92 ± 1.78 mmol/L, and 2-h post-prandial plasma glucose (2-h PPG) by 4.55 ± 2.93 mmol/L (all p < 0.01); 61.66 % of subjects achieved the HbA1c goals of <7 %. A total adverse events incidence of 2.47 % was observed, including an incidence of 1.68 % treatment-emergent adverse events. The incidence of hypoglycaemia was 1.57 %. Other nateglinide-related adverse events (including gastrointestinal disorders, rash and allergic dermatitis) were also reported. There were no serious adverse effects.
The combination of nateglinide and metformin is a safe and effective means of achieving glycaemic target in Chinese patients with T2DM.
糖尿病已成为中国主要的公共卫生问题。本开放性、前瞻性、多中心、上市后监测研究旨在评估那格列奈联合二甲双胍治疗中国 2 型糖尿病（T2DM）患者的疗效和安全性。
共纳入 892 例 T2DM 患者，其中 361 例患者曾接受二甲双胍治疗，531 例患者未曾接受任何口服降糖药治疗。所有患者接受那格列奈 120mg，每日 3 次，于餐前 15 分钟内服用，同时联合二甲双胍（剂量和服用频率不受限制）治疗 12 周。进行体格检查、实验室检查和疗效相关检查，并记录和监测不良事件和患者依从性。
自基线至第 12 周，糖化血红蛋白（HbA1c）降低 1.52%±1.25%（均数±标准差），空腹血糖（FPG）降低 1.92±1.78mmol/L，餐后 2 小时血糖（2-h PPG）降低 4.55±2.93mmol/L（均 p<0.01）；61.66%的患者达到 HbA1c<7%的目标。总不良事件发生率为 2.47%，包括 1.68%的治疗中出现的不良事件。低血糖发生率为 1.57%。其他与那格列奈相关的不良事件（包括胃肠道紊乱、皮疹和过敏性皮炎）也有报道。无严重不良事件。
那格列奈联合二甲双胍是中国 T2DM 患者实现血糖目标的安全有效手段。
