Hassanein Mohamed, Abdallah Khalifa, Schweizer Anja
Betsi Cadwaladr University Health Board, Wales, United Kingdom.
Clinical Research Center, Alexandria University Hospital, Alexandria, Egypt.
Vasc Health Risk Manag. 2014 May 28;10:319-26. doi: 10.2147/VHRM.S64038. eCollection 2014.
Several observational studies were conducted with vildagliptin in patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan, showing significantly lower incidences of hypoglycemia with vildagliptin versus sulfonylureas, including gliclazide. It was of interest to complement the existing real-life evidence with data from a randomized, double-blind, clinical trial.
NCT01758380.
This multiregional, double-blind study randomized 557 patients with T2DM (mean glycated hemoglobin [HbA1c], 6.9%), previously treated with metformin and any sulfonylurea to receive either vildagliptin (50 mg twice daily) or gliclazide plus metformin. The study included four office visits (three pre-Ramadan) and multiple telephone contacts, as well as Ramadan-focused advice. Hypoglycemic events were assessed during Ramadan; HbA(1c) and weight were analyzed before and after Ramadan.
The proportion of patients reporting confirmed (<3.9 mmol/L and/or severe) hypoglycemic events during Ramadan was 3.0% with vildagliptin and 7.0% with gliclazide (P=0.039; one-sided test), and this was 6.0% and 8.7%, respectively, for any hypoglycemic events (P=0.173). The adjusted mean change pre- to post-Ramadan in HbA(1c) was 0.05%±0.04% with vildagliptin and -0.03%±0.04% with gliclazide, from baselines of 6.84% and 6.79%, respectively (P=0.165). In both groups, the adjusted mean decrease in weight was -1.1±0.2 kg (P=0.987). Overall safety was similar between the treatments.
In line with the results from previous observational studies, vildagliptin was shown in this interventional study to be an effective, safe, and well-tolerated treatment in patients with T2DM fasting during Ramadan, with a consistently low incidence of hypoglycemia across studies, accompanied by good glycemic and weight control. In contrast, gliclazide showed a lower incidence of hypoglycemia in the present interventional than the previous observational studies. This is suggested to be linked to the specific circumstances of this study, including frequent patient-physician contacts, Ramadan-focused advice, a recent switch in treatment, and very well-controlled patients, which is different from what is often seen in real life.
针对在斋月期间禁食的2型糖尿病（T2DM）患者开展了多项使用维格列汀的观察性研究，结果显示与磺脲类药物（包括格列齐特）相比，维格列汀导致低血糖的发生率显著更低。用一项随机、双盲临床试验的数据补充现有实际生活证据很有意义。
NCT01758380。
这项多中心、双盲研究将557例T2DM患者（糖化血红蛋白[HbA1c]均值为6.9%）随机分组，这些患者之前接受过二甲双胍和任何一种磺脲类药物治疗，分别接受维格列汀（每日两次，每次50 mg）或格列齐特加二甲双胍治疗。该研究包括四次门诊就诊（三次在斋月前）和多次电话联系，以及针对斋月的建议。在斋月期间评估低血糖事件；在斋月前后分析HbA1c和体重。
在斋月期间报告确诊低血糖事件（血糖<3.9 mmol/L和/或严重低血糖）的患者比例，维格列汀组为3.0%，格列齐特组为7.0%（P=0.039；单侧检验），任何低血糖事件的比例分别为6.0%和8.7%（P=0.173）。斋月前后HbA1c的调整后平均变化，维格列汀组为0.05%±0.04%，格列齐特组为-0.03%±0.04%，基线分别为6.84%和6.79%（P=0.165）。两组的体重调整后平均减轻均为-1.1±0.2 kg（P=0.987）。两种治疗的总体安全性相似。
与之前观察性研究的结果一致，在这项干预性研究中，维格列汀被证明是在斋月期间禁食的T2DM患者中一种有效、安全且耐受性良好的治疗方法，在各项研究中低血糖发生率始终较低，同时血糖和体重控制良好。相比之下，在本干预性研究中格列齐特的低血糖发生率低于之前的观察性研究。这可能与本研究的特定情况有关，包括患者与医生的频繁接触、针对斋月的建议、近期治疗方案的转换以及患者控制良好，这与现实生活中常见的情况不同。
