一项双盲随机试验，包括患者与医生的频繁接触以及针对斋月的建议，评估维格列汀和格列齐特在斋月期间禁食的2型糖尿病患者中的应用：STEADFAST研究。
A double-blind, randomized trial, including frequent patient-physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST study.
作者信息
Hassanein Mohamed, Abdallah Khalifa, Schweizer Anja
机构信息
Betsi Cadwaladr University Health Board, Wales, United Kingdom.
Clinical Research Center, Alexandria University Hospital, Alexandria, Egypt.
出版信息
Vasc Health Risk Manag. 2014 May 28;10:319-26. doi: 10.2147/VHRM.S64038. eCollection 2014.
BACKGROUND
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.
CLINICAL TRIALS IDENTIFIER
NCT01758380.
METHODS
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.
RESULTS
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.
CONCLUSION
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.
背景
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。
临床试验标识符
NCT01758380。
方法
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。
结果
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。
结论
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。
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