Aschner Pablo, Kipnes Mark S, Lunceford Jared K, Sanchez Matilde, Mickel Carolyn, Williams-Herman Debora E
Colombian Diabetes Association, Bogotá, Colombia.
Diabetes Care. 2006 Dec;29(12):2632-7. doi: 10.2337/dc06-0703.
To examine the efficacy and safety of once-daily oral sitagliptin as monotherapy in patients with type 2 diabetes.
In a randomized, double-blind, placebo-controlled study, 741 patients (baseline HbA(1c) [A1C] 8.0%) were randomized to sitagliptin 100 or 200 mg or placebo for 24 weeks.
Sitagliptin 100 and 200 mg produced significant (P < 0.001) placebo-subtracted reductions in A1C (-0.79 and -0.94%, respectively) and fasting plasma glucose (-1.0 mmol/l [-17.1 mg/dl] and -1.2 mmol/l [-21.3 mg/dl], respectively). Patients with baseline A1C >or=9% had greater reductions in placebo-subtracted A1C with sitagliptin 100 and 200 mg (-1.52 and -1.50%, respectively) than those with baseline A1C <8% (-0.57 and -0.65%) or >or=8 to <9.0% (-0.80 and -1.13%, respectively). In a meal tolerance test, sitagliptin 100 and 200 mg significantly decreased 2-h postprandial glucose (PPG) (placebo-subtracted PPG -2.6 mmol/l [-46.7 mg/dl] and -3.0 mmol/l [-54.1 mg/dl], respectively). Results for the above key efficacy parameters were not significantly different between sitagliptin doses. Homeostasis model assessment of beta-cell function and proinsulin-to-insulin ratio improved with sitagliptin. The incidence of hypoglycemia was similar, and overall gastrointestinal adverse experiences were slightly higher with sitagliptin. No meaningful body weight changes from baseline were observed with sitagliptin 100 (-0.2 kg) or 200 mg (-0.1 kg). The body weight change with placebo (-1.1 kg) was significantly (P < 0.01) different from that observed with sitagliptin.
In this 24-week study, once-daily sitagliptin monotherapy improved glycemic control in the fasting and postprandial states, improved measures of beta-cell function, and was well tolerated in patients with type 2 diabetes.
研究每日一次口服西格列汀单药治疗2型糖尿病患者的疗效和安全性。
在一项随机、双盲、安慰剂对照研究中，741例患者（基线糖化血红蛋白 [A1C] 8.0%）被随机分为接受100或200 mg西格列汀或安慰剂治疗24周。
100 mg和200 mg西格列汀使A1C较安慰剂显著降低（P < 0.001）（分别降低-0.79%和-0.94%），空腹血糖也显著降低（分别降低-1.0 mmol/L [-17.1 mg/dl]和-1.2 mmol/L [-21.3 mg/dl]）。基线A1C≥9%的患者，100 mg和200 mg西格列汀治疗后较安慰剂的A1C降低幅度（分别为-1.52%和-1.50%）大于基线A1C<8%的患者（分别为-0.57%和-0.65%）或基线A1C≥8%至<9.0%的患者（分别为-0.80%和-1.13%）。在一项进餐耐量试验中，100 mg和200 mg西格列汀显著降低餐后2小时血糖（PPG）（较安慰剂降低的PPG分别为-2.6 mmol/L [-46.7 mg/dl]和-3.0 mmol/L [-54.1 mg/dl]）。西格列汀不同剂量组上述关键疗效参数的结果无显著差异。西格列汀可改善β细胞功能的稳态模型评估及胰岛素原与胰岛素比值。低血糖发生率相似，西格列汀治疗的总体胃肠道不良事件略多。100 mg（-0.2 kg）或200 mg（-0.1 kg）西格列汀治疗后与基线相比体重无有意义的变化。安慰剂组体重变化（-1.1 kg）与西格列汀组相比有显著差异（P < 0.01）。
在这项为期24周的研究中，每日一次西格列汀单药治疗可改善2型糖尿病患者空腹和餐后血糖控制，改善β细胞功能指标，且耐受性良好。
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