A double-blind randomized comparison of meal-related glycemic control by repaglinide and glyburide in well-controlled type 2 diabetic patients
A double-blind randomized comparison of meal-related glycemic control by repaglinide and glyburide in well-controlled type 2 diabetic patients
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DOI：
10.2337/diacare.22.5.789
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发表时间：
1999-05-01
期刊：
影响因子：
16.2
通讯作者：
Windfeld, K
中科院分区：
文献类型：
--
作者：
Damsbo, P;Clauson, P;Windfeld, K
目的-本研究旨在比较瑞格列奈或格列本脲治疗控制良好的2型糖尿病患者的昼夜血糖波动和意外饮食不依从性的影响。研究设计和方法-本单中心双盲随机研究包括2型糖尿病患者，其在瑞格列奈/格列本脲治疗后的平均空腹血糖值。格列本脲滴定和稳定的范围为90-140 mg/dl。研究包括初始筛选日、3周滴定期、1周稳定期和研究期。在为期3天的研究期间，每组一半的患者在第一天吃两餐，在接下来的2天吃三餐，另一半则相反。瑞格列奈每餐前给药，格列本脲按照当前标签中的建议给药，即，早餐和晚餐前每日服用一次或两次，无论是否省略了午餐。两组之间的一天，其中三餐吃的昼夜血糖波动进行了比较，和最低血糖浓度（BG（分钟））的测量进行了比较，午餐和晚餐的日子，三餐和两餐。结果-的83名随机患者，43进入为期3天的研究期间，并完成了试验。结果显示，瑞格列奈组和格列本脲组的平均血糖偏离空腹血糖无显著差异（P = 0.44）。瑞格列奈组和格列本脲组之间，禁食对平均BG、的影响存在显著差异（P = 0.014）。在后一组中，由于不吃午餐，BG（min）从77降至61 mg/dl，而瑞格列奈组中，两餐日（78 mg/dl）和三餐日（76 mg/dl）的BG（min）不变。所有低血糖事件（n = 6）均发生在格列本脲组的两餐日，与不吃午餐有关。瑞格列奈组无低血糖事件记录。结论-这些结果表明，瑞格列奈治疗控制良好的2型糖尿病患者谁错过或延迟进餐是上级治疗长效磺酰脲类药物（如格列本脲）方面的低血糖发作的风险。
OBJECTIVE - This study was designed to compare diurnal blood glucose excursions and the effects of accidental dietary noncompliance in type 2 diabetic patients who are well-controlled on either repaglinide or glyburide treatment.RESEARCH DESIGN AND METHODS - This single-center double-blind randomized study comprised type 2 diabetic patients whose mean fasting blood glucose value after repaglinide/glyburide titration and stabilization was in the range of 90-140 mg/dl. The study consisted of an initial screening day, a titration period of 3 weeks, a 1-week stabilization period, a study period. and an end-of-study day During the 3-day study period, half the patients of each group received two meals on the first day and three meals on the next 2 days, and in the other half, this sequence was reversed. Repaglinide was administered preprandially with each meal, and glyburide was administered as recommended in current labeling, i.e., either one or two daily doses before breakfast and dinner, regardless of whether lunch had been omitted. The diurnal blood glucose excursions on a day in which three meals were eaten were compared between the two groups, and the minimum blood glucose concentration (BG(min)) measurements were compared between lunch and dinner on days with three and two meals.RESULTS - Of the 83 randomized patients, 43 entered into the 3-day study period and completed the trial. The results showed no significant differences between the repaglinide and glyburide groups in average blood glucose excursions from fasting blood glucose (P = 0.44). The influence on the mean BG,,, of omitting a meal differed significantly between the repaglinide and glyburide groups (P = 0.014). In the latter group, BG(min) decreased from 77 to 61 mg/dl as a result of omitting lunch, whereas in the repaglinide group, BG(min) was unchanged for the two-meal day (78 mg/dl) and the three-meal day (76 mg/dl). All hypoglycemic events (n = 6) occurred in the glyburide group on the two-meal day, in connection with omitting lunch. No hypoglycemic events were recorded in the repaglinide group.CONCLUSIONS - These results suggest that treatment with repaglinide in well-controlled type 2 diabetic patients who miss or delay a meal is superior to treatment with longer-acting sulfonylurea drugs (such as glyburide) with respect to the risk of hypoglycemic episodes.